Complementary Medicines. Registration: Process, Format and Requirements

Transcription

1 Complementary Medicines Registration: Process, Format and Requirements Feb 2014 Estelle Taute

2 Overview Registration process Dossier format Requirements - Guidelines - Technical Quality, Safety, Efficacy - Administrative Presentation Slide 2

3 Registration Process Slide 3

4 Registration Process Screening Complies Yes Final application No Applicant response Reports to Committees Dispatch to evaluators No Not accept Back to relevant Committee Complies Yes Product to MCC Reject Accept Register 4 Slide 4

5 Committees involved in the registration process Complementary Medicines Committee Pharmaceutical & Analytical Committee - Quality - Bioavailability - GMP Names and Scheduling Committee Clinical Committee Biological Medicines Committee (for biological medicines) Veterinary Clinical Committee (for veterinary medicines)

6 Format of application CTD Common Technical Document - Signed-off by ICH in November Common harmonised FORMAT for the submission of information to the regulatory authorities in the 3 ICH regions + South Africa - Compulsory June 2011

7 Format of application cont. CTD is only a FORMAT a TEMPLATE for presenting data in the dossier It is not a single dossier, with a single content

8 Module 1 Regional Information 1.0 Module 1: Not Part of the CTD Content to be determined by authorities CTD Table of Contents 2.1 Module 2 Module 2 Quality Overall Summary 2.3 CTD Introduction 2.2 Non-clinical Overview 2.4 Non-clinical Summaries 2.6 Clinical Overview 2.5 Clinical Summary 2.7 Module 2-5 CTD Modules 3-5 Module 3 Quality 3.0 Module 4 Non-clinical Study Reports 4.0 Module 5 Clinical Study Reports 5.0 8

9 Specifics for ZA Module 1: Administrative Information Letter of application Application Form Package insert and labels Inspectorate requirements Foreign registration status Module 3.2.R Specific quality requirements 9

10 What Guides the Submission & Evaluation?

11 Requirements Requirements make the process more efficient Slide 11

12 Requirements Quality, Safety, Efficacy Guidelines Main guideline Other guidelines referred to Limit duplication Slide 12

13 Requirements cont. Complementary Medicines - Use of the ZA-CTD Format in the Preparation of a Registration Application - Summary CTD structure - Appendix 1 - Quality Complementary Medicines Quality, Safety, Efficacy Guidance for ZA CTD General and Module 1 General Information Pharmaceutical and Analytical (P&A) CTD Stability Dissolution Biostudies Amendments Slide 13

14 Requirements cont. Post-Importation testing Alcohol content Patient Information Leaflets (PILs) Package Inserts for Human Medicines Proprietary Names for Medicines Guide to Good Manufacturing Practice for Medicines in South Africa Forms, e.g. Application Form in the CTD (module 1.2.1) Screening Template for new application for registration Licence Application to Manufacture, Import or Export Medicine Slide 14

15 Quality - Module 3 S - Substance (API) Manufacturer/supplier Container Specifications & procedures Stability P - Finished pharmaceutical product (FPP) FP and intermediate Manufacturer(s) Manufacturing and analytical procedures Specifications & procedures Stability Packaging material A - Appendices R - Regional

16 Presentation

17 Guidance for the submission of the South African CTD/eCTD General & Module 1 General Information Presentation Thickness 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

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19 Binding

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21 Presentation cont. ToCs CTD has specific slots Guidelines describe the requirements ToC page numbers of reports linked to document as numbered by applicant

22 Presentation cont. 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

23 Header clear, not cluttered 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.

24 Presentation cont. 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

25 Presentation cont. 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.

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