presentation on regulatory affairs 30032013
DESCRIPTION
Invited lecture by Institute of Research & Development, Gujarat Forensic Science University and Lab.TRANSCRIPT
Dr Nishodh Saxena
30th March 2013
Regulatory Affairs
What is the product
Is the quality presented acceptable on grounds of safety and
efficacy
Is the quality presented reproducible
How long can the quality be maintained
Quality must ensure consistency of safety and efficacy during the shelf life of all
batches produced
Data in the dossier should enable us to answer
the following questions
Requirements of Documents for Marketing Authorization in INDIA
1 Duly filled and signed form as per the requirement
2 Copy of the challan of Fee paid
3 Land possession document
4 List of Directors
5 Memorandum of article of association
6 Authority letter for authorized signatury
7 Copy of the form 46 (approval of CT)
8 Copy of the approved plant layout
9 Site Master File
10Copy of NOC of Pollution control board
11Water system P amp I diagram
12HVAC details and Area qualification report
13Process flow chart
14List of SOPs
15Specification
16Copy of approval and contract of Waste disposal
Requirements of Documents for Marketing Authorization in INDIA
17 List of equipments for Manufacturing
18 List of equipments for Quality Control
19 List of Products in 6 copies
20 Draft Label
21 List of Technical Staff
22 Any other document as required eg Inspection report
Compliance report Check compliance report CoAs Undertaking
etc
Commonly used forms as per D amp C Act 1940
1 Form 24 Application for products of C C (1) and X
2 Form 25 License C C (1) and X
3 Form 27 Application for products excluding C C (1) and X
4 Form 28 License for products excluding C C (1) and X
5 Form 29 License for purpose of examination test or analysis
6 Form 30 Application for purpose of examination test or analysis
7 Form 35 Inspection book
8 Form 46 Permissionapproval for manufacture of New Drug
Formulation
Track sheet for the documents required for filling and approvals
1 Product-Brand
2 Product-Generic
3 Npd Form for the country
4 IDR Proof
5 DCI-Domestic
6 NOC-Export
7 Mfg Lic
8 COPP
9 BMR
10BPR
11RM SpecSTP
12FP SpecSTP
13PM SpecSTP
14RM COA
15FP COA
16API COA
Track sheet for the documents required for filling and approvals
17 AMV-FP
18 PVPPVR
19 Stability Acc Study data
20 Stability Real Time Study data
21 BEBA or CT Report
22 FP Samples
23 API Open Part DMF
24 FP Chromatogram
25 API Chromatogram
26 Working Standard
27 Literature
International Conference of Harmonization (ICH)
bull European Union
bull USA
bull Japan
The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
Non-ICH countries covers all countries outside ICH includes also
Canada Switzerland Australia and ASEAN
ICH Non-ICH countries
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
What is the product
Is the quality presented acceptable on grounds of safety and
efficacy
Is the quality presented reproducible
How long can the quality be maintained
Quality must ensure consistency of safety and efficacy during the shelf life of all
batches produced
Data in the dossier should enable us to answer
the following questions
Requirements of Documents for Marketing Authorization in INDIA
1 Duly filled and signed form as per the requirement
2 Copy of the challan of Fee paid
3 Land possession document
4 List of Directors
5 Memorandum of article of association
6 Authority letter for authorized signatury
7 Copy of the form 46 (approval of CT)
8 Copy of the approved plant layout
9 Site Master File
10Copy of NOC of Pollution control board
11Water system P amp I diagram
12HVAC details and Area qualification report
13Process flow chart
14List of SOPs
15Specification
16Copy of approval and contract of Waste disposal
Requirements of Documents for Marketing Authorization in INDIA
17 List of equipments for Manufacturing
18 List of equipments for Quality Control
19 List of Products in 6 copies
20 Draft Label
21 List of Technical Staff
22 Any other document as required eg Inspection report
Compliance report Check compliance report CoAs Undertaking
etc
Commonly used forms as per D amp C Act 1940
1 Form 24 Application for products of C C (1) and X
2 Form 25 License C C (1) and X
3 Form 27 Application for products excluding C C (1) and X
4 Form 28 License for products excluding C C (1) and X
5 Form 29 License for purpose of examination test or analysis
6 Form 30 Application for purpose of examination test or analysis
7 Form 35 Inspection book
8 Form 46 Permissionapproval for manufacture of New Drug
Formulation
Track sheet for the documents required for filling and approvals
1 Product-Brand
2 Product-Generic
3 Npd Form for the country
4 IDR Proof
5 DCI-Domestic
6 NOC-Export
7 Mfg Lic
8 COPP
9 BMR
10BPR
11RM SpecSTP
12FP SpecSTP
13PM SpecSTP
14RM COA
15FP COA
16API COA
Track sheet for the documents required for filling and approvals
17 AMV-FP
18 PVPPVR
19 Stability Acc Study data
20 Stability Real Time Study data
21 BEBA or CT Report
22 FP Samples
23 API Open Part DMF
24 FP Chromatogram
25 API Chromatogram
26 Working Standard
27 Literature
International Conference of Harmonization (ICH)
bull European Union
bull USA
bull Japan
The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
Non-ICH countries covers all countries outside ICH includes also
Canada Switzerland Australia and ASEAN
ICH Non-ICH countries
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Requirements of Documents for Marketing Authorization in INDIA
1 Duly filled and signed form as per the requirement
2 Copy of the challan of Fee paid
3 Land possession document
4 List of Directors
5 Memorandum of article of association
6 Authority letter for authorized signatury
7 Copy of the form 46 (approval of CT)
8 Copy of the approved plant layout
9 Site Master File
10Copy of NOC of Pollution control board
11Water system P amp I diagram
12HVAC details and Area qualification report
13Process flow chart
14List of SOPs
15Specification
16Copy of approval and contract of Waste disposal
Requirements of Documents for Marketing Authorization in INDIA
17 List of equipments for Manufacturing
18 List of equipments for Quality Control
19 List of Products in 6 copies
20 Draft Label
21 List of Technical Staff
22 Any other document as required eg Inspection report
Compliance report Check compliance report CoAs Undertaking
etc
Commonly used forms as per D amp C Act 1940
1 Form 24 Application for products of C C (1) and X
2 Form 25 License C C (1) and X
3 Form 27 Application for products excluding C C (1) and X
4 Form 28 License for products excluding C C (1) and X
5 Form 29 License for purpose of examination test or analysis
6 Form 30 Application for purpose of examination test or analysis
7 Form 35 Inspection book
8 Form 46 Permissionapproval for manufacture of New Drug
Formulation
Track sheet for the documents required for filling and approvals
1 Product-Brand
2 Product-Generic
3 Npd Form for the country
4 IDR Proof
5 DCI-Domestic
6 NOC-Export
7 Mfg Lic
8 COPP
9 BMR
10BPR
11RM SpecSTP
12FP SpecSTP
13PM SpecSTP
14RM COA
15FP COA
16API COA
Track sheet for the documents required for filling and approvals
17 AMV-FP
18 PVPPVR
19 Stability Acc Study data
20 Stability Real Time Study data
21 BEBA or CT Report
22 FP Samples
23 API Open Part DMF
24 FP Chromatogram
25 API Chromatogram
26 Working Standard
27 Literature
International Conference of Harmonization (ICH)
bull European Union
bull USA
bull Japan
The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
Non-ICH countries covers all countries outside ICH includes also
Canada Switzerland Australia and ASEAN
ICH Non-ICH countries
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Requirements of Documents for Marketing Authorization in INDIA
17 List of equipments for Manufacturing
18 List of equipments for Quality Control
19 List of Products in 6 copies
20 Draft Label
21 List of Technical Staff
22 Any other document as required eg Inspection report
Compliance report Check compliance report CoAs Undertaking
etc
Commonly used forms as per D amp C Act 1940
1 Form 24 Application for products of C C (1) and X
2 Form 25 License C C (1) and X
3 Form 27 Application for products excluding C C (1) and X
4 Form 28 License for products excluding C C (1) and X
5 Form 29 License for purpose of examination test or analysis
6 Form 30 Application for purpose of examination test or analysis
7 Form 35 Inspection book
8 Form 46 Permissionapproval for manufacture of New Drug
Formulation
Track sheet for the documents required for filling and approvals
1 Product-Brand
2 Product-Generic
3 Npd Form for the country
4 IDR Proof
5 DCI-Domestic
6 NOC-Export
7 Mfg Lic
8 COPP
9 BMR
10BPR
11RM SpecSTP
12FP SpecSTP
13PM SpecSTP
14RM COA
15FP COA
16API COA
Track sheet for the documents required for filling and approvals
17 AMV-FP
18 PVPPVR
19 Stability Acc Study data
20 Stability Real Time Study data
21 BEBA or CT Report
22 FP Samples
23 API Open Part DMF
24 FP Chromatogram
25 API Chromatogram
26 Working Standard
27 Literature
International Conference of Harmonization (ICH)
bull European Union
bull USA
bull Japan
The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
Non-ICH countries covers all countries outside ICH includes also
Canada Switzerland Australia and ASEAN
ICH Non-ICH countries
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Commonly used forms as per D amp C Act 1940
1 Form 24 Application for products of C C (1) and X
2 Form 25 License C C (1) and X
3 Form 27 Application for products excluding C C (1) and X
4 Form 28 License for products excluding C C (1) and X
5 Form 29 License for purpose of examination test or analysis
6 Form 30 Application for purpose of examination test or analysis
7 Form 35 Inspection book
8 Form 46 Permissionapproval for manufacture of New Drug
Formulation
Track sheet for the documents required for filling and approvals
1 Product-Brand
2 Product-Generic
3 Npd Form for the country
4 IDR Proof
5 DCI-Domestic
6 NOC-Export
7 Mfg Lic
8 COPP
9 BMR
10BPR
11RM SpecSTP
12FP SpecSTP
13PM SpecSTP
14RM COA
15FP COA
16API COA
Track sheet for the documents required for filling and approvals
17 AMV-FP
18 PVPPVR
19 Stability Acc Study data
20 Stability Real Time Study data
21 BEBA or CT Report
22 FP Samples
23 API Open Part DMF
24 FP Chromatogram
25 API Chromatogram
26 Working Standard
27 Literature
International Conference of Harmonization (ICH)
bull European Union
bull USA
bull Japan
The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
Non-ICH countries covers all countries outside ICH includes also
Canada Switzerland Australia and ASEAN
ICH Non-ICH countries
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Track sheet for the documents required for filling and approvals
1 Product-Brand
2 Product-Generic
3 Npd Form for the country
4 IDR Proof
5 DCI-Domestic
6 NOC-Export
7 Mfg Lic
8 COPP
9 BMR
10BPR
11RM SpecSTP
12FP SpecSTP
13PM SpecSTP
14RM COA
15FP COA
16API COA
Track sheet for the documents required for filling and approvals
17 AMV-FP
18 PVPPVR
19 Stability Acc Study data
20 Stability Real Time Study data
21 BEBA or CT Report
22 FP Samples
23 API Open Part DMF
24 FP Chromatogram
25 API Chromatogram
26 Working Standard
27 Literature
International Conference of Harmonization (ICH)
bull European Union
bull USA
bull Japan
The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
Non-ICH countries covers all countries outside ICH includes also
Canada Switzerland Australia and ASEAN
ICH Non-ICH countries
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Track sheet for the documents required for filling and approvals
17 AMV-FP
18 PVPPVR
19 Stability Acc Study data
20 Stability Real Time Study data
21 BEBA or CT Report
22 FP Samples
23 API Open Part DMF
24 FP Chromatogram
25 API Chromatogram
26 Working Standard
27 Literature
International Conference of Harmonization (ICH)
bull European Union
bull USA
bull Japan
The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
Non-ICH countries covers all countries outside ICH includes also
Canada Switzerland Australia and ASEAN
ICH Non-ICH countries
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
International Conference of Harmonization (ICH)
bull European Union
bull USA
bull Japan
The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
Non-ICH countries covers all countries outside ICH includes also
Canada Switzerland Australia and ASEAN
ICH Non-ICH countries
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
ASEAN Association of South-East Asian Nations
Population 500 millions
Member countries (10)
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2 Ukrain
3 Kazakhastan
4 Belarus (Head Quarter)
5 Uzbekistan
6 Turmenistan (associate member)
7 Azerbaijan
8 Georgia
9 Armenia
10 Kyrgyzstan
11 Tajakistan
12 Moldova
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
RoW (Rest of the World)
RoW is Rest of the World excluding
UK USA Other Euro American Countries (OEAC) including
Australia New Zealand amp Canada
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
ICH-CTD Dossier
Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada Switzerland Australia Croatia)
Organization of ICH-CTD
ICH-CTD dossier (Module 1 2 3 4 and 5)
Module 1 Administrative documents Labeling texts and mock-ups
Module 2 Overviews and Summaries
Module 3 Quality Data
Module 4 Preclinical Data
Module 5 Clinical Data
General requirements for marketing authorization application for
Biosimilars ndashICH-CTD
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
ASEAN Association of South-East Asian Nations non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format
Organization of A-CTD
A-CTD dossier (Part I II III and IV)
Part I Administrative Information
Part II Quality Document
Part III Preclinical Safety Document
Part IV Clinical Efficacy Document
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
ASEAN Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
ASEAN Association of South-East Asian Nations
Main differences are the organization of data and the numbering of sections
Organization of A-CTD ASEAN-CTD and ICH-CTD
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both
Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD
Part II
Quality Summary
amp
Body of Data
ICH-CTD
Module 2
Quality Overall Summary
Module 3
Quality
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
ICH-CTD Module 3
Module 3
31 MODULE 3 TABLE OF CONTENTS
32 BODY OF DATA
32S DRUG SUBSTANCE
32S1 General Information
32S2 Manufacture
32S3 Characterisation
32S4 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P DRUG PRODUCT
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Control of Drug Product
32P6 Reference Standards or Materials
32P7 Container Closure System
32P8 Stability
Module 3 (Cont)
32A APPENDICES
32A1 Facilities and Equipment
32A2 Adventitious Agents Safety Evaluation
32A3 Novel Excipients
32R REGIONAL INFORMATION
33 LITERATURE REFERENCES
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Section C Body of Data
S DRUG SUBSTANCE
S 1 General Information
S 11 Nomenclature
S 12 Structural formula
S 13 General Properties
S 2 Manufacture
S 21 Manufacturer(s)
S 22 Description of Manufacturing Process and Process Controls
S 23 Control of Materials
S 24 Controls of Critical Steps and Intermediates
S 25 Process Validation andor Evaluation
S 26 Manufacturing Process Development
S 3 Characterization
S 31 Elucidation of Structure and Characteristic
S 32 Impurities
S 4 Control of Drug Substance
S 41 Specification
S 42 Analytical Procedures
S 43 Validation of Analytical Procedures
S 44 Batch Analyses
S 45 Justification of Specification
S 5 Reference Standards or Materials
S 6 Container Closure System
S 7 Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability
Commitment
Stability Data
A-CTD Part II Section C (DRUG SUBSTANCE)
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
P DRUG PRODUCT
P 1 Description and Composition
P 2 Pharmaceutical Development
P 21 Information on Development Studies
P 22 Component of Drug Product
P 221 Active Ingredients
P 222 Excipients
P 23 Finished Product
P 231 Formulation Development
P 232 Overages
P 233 Physicochemical and Biological Properties
P 24 Manufacturing Process Development
P 25 Container Closure System
P 26 Microbiological Attributes
P 27 Compatibility
P 3 Manufacture
P 31 Batch Formula
P 32 Manufacturing Process and Process Control
P 33 Controls of Critical Steps and Intermediates
P 34 Process Validation andor Evaluation
P 4 Control of Excipients
P 41 Specification
P 42 Analytical Procedures
P 43 Excipients of Human and Animal Origin
P 44 Novel Excipients
P 5 Control of Finished Product
P 51 Specification
P 52 Analytical Procedures
P 53 Validation of Analytical Procedures
P 54 Batch analyses
P 55 Characterization of Impurities
P 56 Justification of Specification
P 6 Reference Standards or Materials
P 7 Container closure system
P 8 Product Stability
Stability Summary and Conclusion
Post-approval stability protocol and stability
commitment
Stability Data
P 9 Product Interchangeability
Section D Key Literature References
A-CTD Part II Section C (DRUG PRODUCT)
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
bull API specification as per EP
bull STP of DS as per specification
Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required Method Validation is not required
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
1048708 Special documents requested
Appendix 8 Singapore Quality Overall Summary for Biologic
Validation sheet
Singapore Stability sheet
Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 EU approval letters
1048708 EU Assessment Reports (from benchmarking countries)
1048708 TGA approval letters if available
1048708 Patent declaration form
1048708 COAs of DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
1048708 Plant Master File registration required before MAA can be submitted
1048708 Administrative documents eg
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 COAs of DS and DP
1048708 Batch Records requested for DP
1048708 Detailed information about quality part requested even very
confidential information
Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
1048708 Detailed information about quality part requested even very confidential
information
1048708 Administrative documents eg
1048708 Application Forms
1048708 CPP
1048708 GMP certificates
1048708 Letter of authorizations (Power of Attorneys)
1048708 Labeling documents
1048708 SOPs for test methods
1048708 COAs of DS and DP
1048708 Only one manufacturer can be registered for DS and DP
Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Important web sites
DCGI-CDSCO httpwwwcdsconicin
DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-
abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5
50001c17psy-
ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb
iw=1280ampbih=923
eg
cdsconicinCDSCO-GuidanceForIndustrypdf
wwwcdsconicinGuidance_for_New_Drug_Approval-23072011
WHO httpwwwwhointen
ICH wwwichorg
US-FDA wwwfdagov
CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp
MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)
EMA wwwemaeuropaeu
TGA wwwtgagovau ( Therapeutic Goods Administration Australias)
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena
Thanks
Contact details Phone 9824443676
Mail ID nishodhsaxenayahocom
Profile inlinkedincomindrnishodhsaxena