Overview of the Complementary Medicines regulatory framework
Lyndall Soper, Assistant Secretary
Complementary and Over-the-Counter Medicines Branch
Medicines Regulation Division
Therapeutic Goods Administration
Australian Acupuncture and Chinese Medicine Annual Conference Perth, 20-22 May 2016
Slide 1 - Overview
- The Complementary Medicines regulatory framework
- Traditional Chinese Medicines within the regulatory framework
- The future of Complementary Medicine regulation
Slide 2 - The challenge
Managing industry innovation with consumer safety
- Industry
- Timely market access
- Consistent, effective transparent regulation
- Minimal regulatory burden
- International work sharing
- Consumer
- High quality medicines that are safe and affordable
- Efficacious with truthful advertising
- Effective and transparent regulation of all medicines
Slide 3 - Therapeutic Goods Administration
- Established in 1989
- Part of the Department of Health
- Safeguard health of Australian public
- Regulates therapeutic goods (medicines and medical devices)
Slide 4 - What is a Complementary Medicine?
- Complementary Medicines
- Herbal Medicines
- Aromatherapy Products
- Homoeopathic Medicines
- Nutritional Supplements
- Vitamins and Minerals
- Traditional Medicines
Slide 5 - Why do we regulate complementary medicines?
- Safeguard the health of the Australian public
- Safe, high quality medicines
- Manage adverse events
Slide 6 - What the TGA does not regulate
- Practitioners
- Cosmetics
- Health insurance
- Veterinary medicines
- Extemporaneously compounded complementary medicines
- Food products
Slide 7 - Regulatory framework for complementary medicines
- Therapeutic Goods Act 1989 (the Act)
- Therapeutic Goods Regulations 1990
- Poisons standard
Slide 8 - A risk-based approach to regulation
- Australian Register of Therapeutic Goods (ARTG)
- AUST L - Listed medicines (lower risk)
- Low level indications
- Low risk ingredients
- No premarket evaluation of product
- AUST R - Registered medicines (higher risk)
Slide 9 - Image of packaging highlighting where the AUST L number is located

Slide 10 - Listed medicines regulatory framework
No premarket evaluation

- Listed medicines containing an 'AUST L' are not individually evaluated prior to being supplied in Australia.
- This means that they must contain ingredients which have been assessed by the TGA for quality and safety (but not efficacy).
- A sponsor is required to certify that they have met these conditions before submitting an application for a new medicine.
Slide 11 - Applying for a listed medicine
- Electronic application:
- Electronic Listing Facility (ELF)
- Easy access to market:
- Supply within 48 hours of applying
Slide 12 - Pre-approved ingredients
Pre-approved ingredients > GMP > Low Level therapeutic claims
- Low risk
- Some restrictions:
- Limits
- Route of administration
- Plant parts, type of preparation
- Labels
- Container type
Slide 13 - We are often asked why the TGA does not allow some TCM?
- Potential reasons:
- Legislative restriction
- Negative outcome from previous evaluation
- No previous application
- Risk based approach
- Something that has been used traditionally doesn't always mean it is safe
- Safety concerns require further scientific data to show absence of the concern
- We can consider internationally recognised safety reports (e.g. from Health Canada, EFSA)
Slide 14 - Good Manufacturing Practice (GMP)
Pre-approved ingredients > GMP > Low Level therapeutic claims
Slide 15 - Evidence for Listed Medicines
Pre-approved ingredients > GMP > Low Level therapeutic claims
- Sponsor: evidence for all indications and claims
- Complementary medicines indications:
- Traditional
- Scientific
- Cross-paradigm
- Evidence Guidelines
Listed medicines compliance framework

- Once a medicine is listed on the ARTG, the medicine may be selected for review to assess whether it meets certain regulatory requirements.
- If the medicine is found to be compliant, it may continue to be supplied,
- but if there is a breach (e.g. if the products are found to be of unacceptable safety, quality or efficacy) then;
- the medicine may be cancelled from the ARTG, which means it can no longer be supplied.
Slide 17 - TGA: Post market compliance
Risk based regulatory approach includes:
- desk-based audits of listed medicines - 'compliance reviews'
- laboratory testing of products and ingredients
- monitoring of adverse reactions
- recalls
- audit of manufacturing sites
- controls for advertising
Slide 18 - Post market compliance at our Branch
Risk based regulatory approach includes:
- desk-based audits of listed medicines - 'compliance reviews'
- laboratory testing of products and ingredients
- monitoring of adverse reactions
- recalls
- audit of manufacturing sites
- controls for advertising
Slide 19 - Registered complementary medicines regulatory framework
Quality > Safety > Efficacy
- If the medicine cannot be listed then it may need to be Registered
Slide 20 - Traditional Indications - Evidence
"Tradition of use"
- Evidence to show use for its intended purpose for at least 3 generations (75 years)
- Only refer to terms within that paradigm
Sources of evidence include:
- National formularies
- Materia medica
- Monographs
- Official pharmacopoeias e.g. Pharmacopoeia of the People's Republic of China
Slide 21 - Scientific Indications - Evidence
Scientific evidence:
Sources of evidence include:
- Clinical studies
- Peer-reviewed published articles
- Pharmacopoeias
- Systematic reviews
Slide 22 - Traditional Chinese Medicines within the regulatory framework
- Adulteration
- Aristolochic acids
- Homeopathic ingredients
Slide 23 - Traditional Chinese Medicines within the regulatory framework
- Adulteration
- Aristolochic acids
- Homeopathic ingredients
Akebia, Asarum, Bragantia, Clematis, Cocculus, Diploclisia, Menispernum, Saussurea, Sinomenium, Stephania, Vladimiria.
Products containing Mu Tong and Fang Ji as ingredients also at risk of containing the Aristolochia species.
Slide 24 - Traditional Chinese Medicines within the regulatory framework
- Adulteration
- Aristolochic acids
- Homeopathic ingredients
Slide 25 - Outcomes of the Medicines and Medical Devices Review (MMDR)
- 58 recommendations altogether
- 19 recommendations for complementary medicines
- Included in the Government's 2016-17 budget statements
- Watch this space
- Department of Health website for more information
Slide 26 - Guidance material
- Australian Regulatory Guidelines for Complementary Medicines (ARGCM)
- Evidence Guidelines
- twitter.com/tgagovau
- tga.gov.au
Slide 27 - Contact us
Complementary and OTC Medicines Branch
Report a perceived breach or questionable practices
Reporting adverse effects