1. Regulatory Overview of Complementary Medicines in South Africa Dr A T Sigobodhla Session : VICH Outreach Forum Tokyo, Japan: 26 – 27 October 2015

2. 2 OUTLINE > Historical background > Introduction > Progress made so far > Current status Associated definitions Legislative framework Current review process > Challenges > The road map > Conclusion

3. HISTORICAL BACKGROUND Over the Counter –Stock Remedies –Act 36/47 Prescription Only –Veterinary Medicines –Act 101/65

4. 4 GUIDING PRINCIPLES Good regulatory practices based on: Clear objectives and efficient/effective framework. Social and economic benefits of regulation outweigh the costs. Regulations: transparent and non-discriminatory Trustworthy environment Risk-based model: timely and precise Harmonisation of regulation and best international practices.

5. 5 INTRODUCTION > CAMs were previously not regulated > There was no regulatory framework > Substances imported, compounded locally and used on animals > Uses: in-feed, ectoparasiticides, insecticides, various treatment claims > No formal review

6. 6 INTRODUCTION cont … > Flooded the market > Multi billion dollar business more so for human CAMs but fewer veterinary CAMs submissions > Call-up notice of 22 nd February 2002 > Flooded with submissions – limited information submitted just to assess how much was being sold out there – no formal review

7. 7 FINDINGS OF THE CALL UP NOTICE Mislabeled products Medicinal claims on labels to treat minor to major ailments including vaccines Formulations contained prohibited substances, high levels of vitamins and minerals and highly scheduled substances – in feed use Large requests on performance enhancement in equines and joint diseases Claims on probiotics – small animals

8. PROGRESS MADE SO FAR Over the Counter –Stock Remedies –Act 36/1947 Prescription Only –Veterinary Medicines –Act 101/1965 VPPTT

9. 9 Veterinary Products Policy Task team Terms of reference of VPPTT Policy on control of all vet medicines/remedies: international best practices Alignment with VICH technical requirements for registration of medicines Monitoring and surveillance program for management of drug resistance and an all encompassing Pharmacovigilance system Dialogue between NRAs & industry: enables response to emerging global issues and science

10. COMMON MISCONCEPTIONS Complementary medicines are not medicines “Natural” means “safe” 10

11. 11 NEED FOR CONTROL OF CAMs > Call for registration of complementary medicines by amending the regulations: 15 November 2013. > Thus there is a requirement to evaluate and pronounce on the quality, safety and efficacy of these medicines

12. 12 CURRENT STATUS

13. Current Status Discipline Specific (DS) Traditional Use Clinical Evidence Health Supplements (HS) Schedule 0 Allowable claims Higher schedule: submit for review Review – if approval is granted then available for use with standardised claim

14. 14 PROPOSED DEFINITION (1) “complementary medicine” means any substance or mixture of substances that- (a) originates from plants, minerals or animals; (b) is used or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal to mitigate, modify, alleviate or prevent illness or the symptoms thereof or abnormal physical or mental state, and (c) is used in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982);

15. 15 PROPOSED DEFINITION (2) "complementary medicine" means any substance or mixture of substances that- (a) originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by Council, and (b) is used or purporting to be suitable for use or manufactured or sold for use – (i) in maintaining, complementing, or assisting the innate healing power or physical or mental state, or (ii) to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or mental state, of a human being or animal, and (c) is used- (i) as a health supplement, or (ii) in accordance with those disciplines as determined by Council, or (d) is declared by the Minister, on recommendation by the Council, by notice in the Gazette to be a complementary medicine;

16. 16 LEGISLATION IN PLACE Guideline: Complementary Medicines – Quality, Safety and Efficacy (Dec 2013 and updated Feb 2014) “Discipline Specific (DS)” New update: to include Health Supplements – Quality, Safety and Efficacy (Nov 2014) – out for Stakeholder comment Opportunity to revise G/L – referred to the VPPTT for further discussion

17. CURRENT REVIEW PROCESS DISICIPLINE SPECIFIC (DS) LOW RISK – Traditional Use AND/OR Clinical Evidence HIGH RISK – Traditional use AND Clinical Evidence Disciplines provided for in DS QSE Guideline ?Consider call up per discipline HEALTH SUPPLEMENTS (HS) “LOW RISK” – unscheduled substances only (S0); prescribed allowable claims No treatment of diseases. As prescribed – HS QSE Guideline Amended Pharmacological Classifications (Regulations) Combinations, high levels need further review

18. 18 CHALLENGES > More expertise required: Experts with relevant training > Adulterated substances still on the market > Industry capacity building: reluctance to regulate > Not compliant with GMP: quality neglected > Analysis: several bio-active constituents and varied effects on a large variety of species > Need for proper distinction between supplements, probiotics and medicines/remedies: vs registrability > No national database of these products and limited literature on animal use > Pharmacovigilance reporting weak on marketed products > Need for refinement of the application process

19. 19 THE ROADMAP Refine the current guidelines to suite veterinary CAMs: Late 2015: Harmonise the technical requirements for all CAMs submissions nationally – VPPTT National database of all listed and marketed products Q1 2016: Abbreviated review with defined time lines for low risk products in terms of quality only and register. ?GMP compliance Q2 2016: Most balanced approach: international cooperation agreements, recognise approaches analysed across the world, recognition of and utilisation of monographs Late Q2 2016: ?MRLs for food producing animals: animal & human safety data

20. 20 CONCLUSION Although we still have challenges, there is already an existing legislative framework for VPPTT to work on Adhere to time lines to refine the current legislation: consultative approach between the NRAs and the Industry Comprehensive national database Human and animal safety data Tighten systems and processes to close loop-holes Strengthen post-marketing surveillance