1. Consultative meeting Registrar of Medicines & Pharmaceutical Industry Ms Mandisa Hela Medicines Regulatory Affairs Department of Health 4 September 2008

2. Overview Pharmaceutical Industry: Compliance with cGMP Available Assistance: dti Marketing Code of Medicines: Proposed EDMS Other

3. ? Pharmaceutical Industry: Compliance with cGMP

4. Act 101 of 1965 Act 101 of 1965: Amendment 2003 – Licensing of Manufacturers – Licensing of Wholesalers Implementation: 2004 – MCC issue licences 2004

5. History of GMP upgrade Identify need for GMP upgrade – Medicines Control Council (MCC) – Industry: need for export – Jointly: Industry and MRA /MCC to obtain PIC/S membership GMP Guideline update – Previous GMP Guideline: 1998 – PIC/S GMP Guideline adopt and adapt – Workshop with Industry PIC/S GMP Guideline [12 workshops] Jan 2004-Jan 2005 – Compare GMP Guide to PIC/S Guide – Incorporated Industry comment into PIC/S Guideline

6. History of GMP upgrade GMP Guideline….cont – MCC published updated GMP Guideline: Nov 2005 – Agreed-to Timeline with Industry for implementation: 6 months – Inspection commencement: June 2006

7. History of GMP upgrade….cont Identified specific areas of non-compliances: HVAC Self-inspections & Contract audits V alidation – Conference re specific aspects of guideline: February 2006 – MCC open-door policy to advise

8. Current GMP status TypeTotal No.CompliantUnder Review MNC880 Generic3216 Closed4 (Generic)

9. ? Assistance: dti

10. ? Marketing Code of Medicines: Proposed

11. Marketing Code of Medicines Medicines Act: Section 18C Enforceable Code of Practice for the Marketing of Medicines

12. Comment: Marketing Code of Medicines Proposed Marketing Code excludes: – Veterinary medicines – Complementary medicines Reference to legislation – Text general e.g. “Minimum requirements” – Spirit of code seems to support any efficacy claim with substantiation / reference

13. Comment: Marketing Code of Medicines Marketing wording: “Safe” / “Natural” – MCC registers: safety, efficacy and quality – Natural versus manipulation – Natural does not translate to “Safe” Clinical trials – Text confusing / registered medicines? Quotations – Text confusing / unregistered indications?

14. Conclusion: Marketing Code of Medicines Thanks to Industry for the effort Clarification on issues raised Communication with the MRA Draft Amendment Bill of Act 101 states there “shall” be an enforceable Code Details will be in Regulations and Guideline documents – Comments invited

15. ? EDMS EDMS Workflow Specification and Software Configuration Project

16. Slide 16 MRA Network Topology

17. Slide 17 It is expected that the EDMS Project will provide the following within the scope of the configuration contract : –Conformance to local regulatory requirements –Conform to international regulatory standards –Conform to Government IT standards –Ability to perform search and retrieval operations on the information stored in the system –Ability to perform workflow management in-house –Provide web-enabled centralised control –Provide necessary tools to perform publication of updated information on website –Provide ability to maintain security/control via digital signatures –Ability to deliver version and iteration control –Provide a clear archiving strategy

18. Slide 18 Major Indicators Local Industry acceptance will be key with particular attention: - security, compatibility of IT systems Electronic process will satisfy environmental & archiving concerns Different Databases integration at MRA Project Management and transparent timeline management Knowledge Management (Management reporting, supervision and efficiency) Format cross indexing (MBR1  MRF1  eCTD) Work in progress, workshops, seminars to follow with all stakeholders Pilot planned: February 2009

19. ? Schedules to Act 101

20. Schedules to Act 101: 5 Sept 08 Government Gazette – Newly developed entities e.g. Human Papillomavirus vaccine (S4) – New designer drugs with abuse potential e.g. 1-Benzylpiperazine (BZP) (S7)

21. Schedules to Act 101: 5 Sept 08 Rescheduling based on new information Clotrimazole (S1), a.when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and b.when intended for application to the skin. (S4)

22. Schedules to Act 101: 5 Sept 08 Improved descriptions e.g. Hyaluronic Acids (S0, S1, S2, S4) – Hyaluronic acid and its salts (S1), when contained in preparations containing 2,5 percent or more intended for topical application to the skin, except preparations containing less than 0,25 percent when intended for topical use in terms of the provisions of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972). (S0, S2, S4)

23. END Drive safely