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Presentation

• Presented by: Lyndall Soper, Assistant Secretary, Complementary and Over-the-Counter Medicines Branch, Medicines Regulation Division, Therapeutic Goods Administration
• Presented at: Australian Acupuncture and Chinese Medicine Annual Conference Perth
• Presentation date: 20-22 May 2016
• Presentation summary: This presentation provides an overview traditional Chinese Medicines with the complementary medicines regulatory framework and the future of complementary medicine regulation

Transcript

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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)
    • Premarket evaluation of:
      • quality
      • safety
      • efficacy

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

• Licence or clearance

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:

• Quantifiable data

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

• complementary.medicines@tga.gov.au
• 1800 020 653 (freecall within Australia)
• 02 6232 8634

Report a perceived breach or questionable practices

• Report a perceived breach or questionable practices

Reporting adverse effects

• TGA eBusiness Services: Australian Adverse Drug Reaction Reporting System

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