Complementary Medicines

CTD

Screening and PresentationModule 1

Estelle Taute31 August 2015

Overview• Registration process

• What is the CTD

• Requirements

• Presentation of submission

• Module 1

• Screening

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CTD and registration process

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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

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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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CTD

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What Guides the Submission & Evaluation?

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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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Presentation

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How will the evaluator find the documents in the CTD?

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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Presentation

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23

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Presentation – practical examples

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Binding

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27

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29

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31

1.0

32

Document name in footer changed

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Left margin too narrow

CTD – Module 1

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Read with 2.24 Guidance General & Module 1

Granularity of Module 1

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2.24: Page 16 of 33

Identification of volumes

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2.24 page 15

Identification of volumes

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??

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1.2.2.2

Incomplete

Incorrect title

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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X

X

Module 1.2.1

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Version?

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Orthodox or Complementary?

Module 1.7.12 Inspection Flow Diagramme

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2.24 page 32

MRF1/CTD

Product release –FPRR = local applicant

Screening

• 6.15 Screening template

6.15_Screening_template_SA_Jun14_v8.docx

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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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CTD

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Conclusion

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