ctd - mcc - medicines control council€¦ · photocopies are legible • ctd sections identified...
Post on 09-Jul-2018
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Overview• Registration process
• What is the CTD
• Requirements
• Presentation of submission
• Module 1
• Screening
2
Registration process
Reject
Not accept
Return to applicant
Screening Final application
Dispatch to evaluators
Complies
Reports to Committees
Applicant response
Product to MCC
Register
Yes
No
Accept
Back to relevant CommitteeComplies
Recommendation to applicant
Not comply
4
Committees involved in the registration process
• Complementary Medicines Committee- QSE
• Pharmaceutical & Analytical Committee- Quality- Bioavailability- GMP
• Names and Scheduling Committee• Clinical Committee• Biological Medicines Committee (for biological medicines)• Veterinary Clinical Committee (for veterinary medicines)
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Application and registration number
• The alphabet was used (excluding I and O) as the first part, and thereafter continued from number 27
• Application number- 2 components, 6 digits in total
• First part indicates year of submission – 2 digits• 2nd part is sequential number – 4 digitse.g. 2015: Numbers start with 50D500020 will mean the 20th CM application received in 2015
• Registration number- The pharmacological classification number is included
e.g. D50/32.3/00206
CTD“Common Technical Document”
- Signed-off by ICH in November 2000- Common harmonised FORMAT for the
submission of information to the regulatory authorities in the 3 ICH regions + South Africa
- Compulsory June 2011 for orthodox medicines
Format of submission
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CTD is only a FORMAT • a TEMPLATE for presenting data in the dossier
It is not a “single” dossier, with a “single” content
It is not a process
Format of submission cont.
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QualityOverall
Summary2.3
Non-clinicalOverview
2.4
ClinicalOverview
2.5
Non-clinicalSummaries
2.6
ClinicalSummary
2.7
Module 3
Quality3.0
Module 4Non-clinical
Study Reports4.0
Module 5Clinical
Study Reports5.0
Module 2
CTD Table of Contents2.1
CTD Introduction2.2
Module 1Regional
Information1.0
Module 2-5CTD
Module 1:Not Part of the CTD Content to be determined by authorities
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Module 2Module 2
Modules 3 - 5
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Requirements
Quality, Safety, EfficacyGuidelines• Main guideline
• Other guidelines referred to- Limit duplication
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• 7.03 Complementary Medicines - Use of the ZA-CTD Format in the Preparation of a Registration Application- Summary CTD structure- Appendix 1 - Quality
• 7.01 Complementary Medicines – Quality, Safety, Efficacy• 7.04 Heath Supplements - QSE• 2.24 Guidance for ZA CTD General and Module 1• 1.01 General Information• 2.25 Pharmaceutical and Analytical (P&A) CTD• 2.05 Stability• 2.07 Dissolution• 2.06 Biostudies• 2.08 Amendments
Requirements cont.
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• 2.04 Post-Importation testing• 2.03 Alcohol content• 2.14 Patient Information Leaflets (PILs)• 2.16 Package Inserts for Human Medicines• 2.15 Proprietary Names for Medicines• 4.01 Guide to Good Manufacturing Practice for Medicines in South
AfricaForms, e.g.• Application Form in the CTD (module 1.2.1)• 6.15 Screening Template for new application for registration• 6.10 Licence Application to Manufacture, Import or Export Medicine
Requirements cont.
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Guidance for the submission of the South African CTD/eCTD – General & Module 1General InformationThickness and binding of ALL documents • Left-hand margin - sufficiently large that information is not obscured
through binding• Avoid shading and/or coloured filling/background and/or print, e.g. in
tables and headers• Binders – no metal file fasteners• Units not to exceed 4 cm including binder
Presentation
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ToCs• CTD has specific slots• Guidelines describe the requirements• ToC page numbers of reports linked to
document as numbered by applicant
Presentation cont.
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• Photocopies are legible• CTD sections identified with tabs, dividers or page numbers• Application form signed by pharmacist• Each volume identified on front cover• Font at least Arial 10 pt (preferably 12)• Sentence case
- Not underlined, upper case, all bold• Pages not reduced to add own headers and footers text
smaller than minimum / illegible• Legibility of chromatograms include the text
Presentation cont.
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• Header clear, not cluttered
• Official forms - Footer & version unchanged – not to be deleted
• Dossier page number ideally bottom right as in footer
• Tabbed dividers- Direction of text on tabs- Title of attachment rather than “Attachment 1”
• Double-sided copies excl Package insert & PIL
• No shading and/or coloured filling/background and/or print, e.g. in tables and headers, across pages
• No foreign languages
Presentation cont.
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• S.I. requirements – metric units- documents completed locally conform –
includes Package Insert and label- Not documents compiled / originating from
elsewhere
• Official headings unchanged- to ensure that all information has been submitted
Presentation cont.
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A well-presented dossier complying with the requirements of the guidelines
will result not only in a speedier outcome but also in trust being built.
Presentation cont.
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Module 1.2.1
• Pharmacist responsible/authorised to communicate with SA Regulatory Authority- Letter of authorisation in Annex 1.2.2.2 – for pharmacist responsible for the
dossier- Not required for Responsible Pharmacist (reg 25(3) of Pharmacy Act)- Should be in the permanent employ of the company
• Particulars of the medicine - Product‐ Category: D “In the case of a complementary medicine, also state the relevant
discipline.”‐ Pharmacological classification: Regulation 25
• 32.3 Slimming preparations (weight reduction products)• 7.1, 21.7, 21.8, 21.9 Sexual stimulation products
‐ Approved name – not to be confused with Proprietary Name39
Module 1.2.1 cont.
• Manufacturing, packaging, testing sites- If more than one site is involved, clearly identify the site for each stage.
• Declaration and signature‐ …. that all the information herein…. are correct and true and relevant to this
particular medicine….‐ Annex 1.2.2.1 fees paid‐ Signature of pharmacist – original signature – not “pp”, not scanned
• Type of application‐ New Application – include only the relevant table for either orthodox or
complementary medicine
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Module 1.7.12 Inspection Flow Diagramme
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2.24 page 32
MRF1/CTD
Product release –FPRR = local applicant
Labelling
What do you have to do now?In terms of the provisions of Regulation 8 of the Medicines and Related Substances Act, 1965 all medicines falling in Category D must comply with the labelling requirements. All complementary or alternative medicines not yet called up for evaluation by the Medicines Control Council must comply with the labelling requirements within 6 months from the date of the Gazette publication. This implies that the label of each complementary medicine shall
• be written in English and at least one other official language
• state on the product label:- the category of medicine- the pharmacological classification of the medicine- the discipline of medicine- the words “This medicine has not been evaluated by the Medicines Control
Council. This medicine is not intended to diagnose, treat, cure or prevent any disease”
• no other information not called for by Regulation 8 except when Council has authorised the inclusion of any such additional information
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Labelling cont.
• “This medicine is to be evaluated by the MCC. This medicine is not intended to diagnose, treat, cure or prevent a disease.”
• “This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.”
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