Complementary Medicines Regulation in Australia

1. Complementary Medicines Regulation in Australia

2. Therapeutic Goods Administration • Unit of the National Government • Therapeutic Goods Act 1989 and Regulations & Therapeutic Goods Orders • Regulates manufactured medicines (and medical devices)

3. TGA Building Canberra

4. Australia New Zealand Therapeutic Products Agency(ANZPA) The New Zealand and Australian Governments have agreed to establish a trans-Tasman therapeutic products agency. From 1 July 2007 the joint agency will replace TGA and the New Zealand Medicines and Medical Devices Safety Authority Medsafe).

5. Products on the Australian Register of Therapeutic Goods 1995 – 2003 Complementary medicines Prescription medicines Registered (pharmacy) medicines Registered complementary medicines (Expert Report: Complementary Medicine in the Australian Health System, September, 2003)

6. Complementary medicines Traditional medicines Vitamins & minerals Homeopathic medicines Herbal medicines Nutritional supplements Aromatherapy products Traditional Chinese Medicines Other Traditional medicines Ayurvedic medicines From TGA/ANZPA presentation 2006

7. Medicines regulation – general Balancing risks and benefits

8. Medicine Classes and Perceived Risk Australian Register of Therapeutic Goods (ARTG)

9. How are therapeutic goods regulated in Australia? • Licensing of manufacturers (international standards of GMP) • Risk-based pre-market evaluation and approval • Higher risk products: quality, safety & efficacy • Lower risk products: quality & safety • Post-market sampling and reporting of adverse events • Controls on advertising • Assessment of medicines for export (quality & safety)

10. Pre-market assessment – registered products • AUST R xxxxx • Assessed for quality, safety and efficacy • Evaluated as either “higher risk” (prescription) or “lower risk” (pharmacy) - depends on: ingredients dosage and dosage form therapeutic claims/indications side effects potential for inappropriate self-medication

11. Pre-market assessment – listed products • AUST L xxxxx • Considered to be of lower risk • Assessed for quality and safety (not efficacy), but • Sponsors required to hold information to substantiate therapeutic claims

12. Medicine Classes and Perceived Risk Australian Register of Therapeutic Goods (ARTG)

13. Office of Complementary Medicine • Separate section within TGA for regulation of complementary medicines • Evaluates/regulates complementary medicine ingredients and products (not complementary medicines dispensed/compounded by practitioners*) *The State of Victoria established the Chinese Medicine Registration Board of Victoria in 2000, to regulate Chinese medicine practice

14. TGA Expert Evaluation Committees • Australian Drug Evaluation Committee (ADEC) • Prescription medicines • Medicines Evaluation Committee (MEC) • Registered non-prescription medicines • Complementary Medicines Evaluation Committee (CMEC) • Complementary medicines • Adverse Drug Reactions Advisory Committee (ADRAC)

15. Types of evidence to support claims • Scientific • Evidence based on traditional use* *Documentary evidence that a substance has been used over three or more generations for a specific health-related or medicinal purpose.

16. www.tga.gov.au

17. High level claims • Reference to a serious disease or disorder • Treatment, cure or management of any disease/disorder/condition • Prevention of any disease/disorder/condition • Treatment of specific named vitamin or mineral deficiency diseases Must be registered, with efficacy evaluated upfront by scientific evidence

18. High level claims - Scientific evidence

19. Medium level claims • Health enhancement • Reduction of risk of a disease/disorder/condition* • Reduction in frequency of a discrete event* • Aids in the management of a named symptom/disease/disorder/condition* • Relief of symptoms of a named* disease/disorder/condition Sponsor must hold the evidence for claims *Excludes serious (registerable) diseases

20. Medium level claims - Scientific evidence Evidence obtained from well designed controlled clinical trials with or without randomisation

21. Medium level claims - Evidence of traditional use

22. General level claims • Health maintenance, including nutritional support • Vitamin or mineral supplementation • Relief of symptoms (not related to a named disease/disorder/condition) Sponsor must hold the evidence for claims

23. General claims - Scientific evidence Descriptive studies, case series or reports of relevant expert committees. Texts, such as TGA-approved pharmacopoeias or monographs.

24. General level claims - Evidence of traditional use

25. Other requirements • Satisfactory safety/toxicity assessment • Quality and presentation assessment acceptable • Sponsor makes a legally binding statement that they hold evidence to support claims made of listed medicines

26. Australian regulatory guidelines for complementary medicines (ARGCM) • Part I: registration of complementary medicines • Part II listing of complementary medicines • Part III: evaluation of complementary medicine substances for use in listed medicines • Part IV: requirements for specific complementary medicine modalities such as traditional Chinese medicine • Part V: TGA policy guidelines relevant to complementary medicines www.tga.gov.au

27. Further information www.tga.gov.au www.anztpa.org