Overview of the Complementary Medicines regulatory framework - - PowerPoint PPT Presentation

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Overview of the Complementary Medicines regulatory framework - - PowerPoint PPT Presentation

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Overview of the Complementary Medicines regulatory framework Australian Acupuncture and Chinese Medicine Annual Conference Perth 2016 Lyndall Soper, Assistant Secretary Complementary and Over-the-Counter Medicines Branch Medicines Regulation

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Overview of the Complementary Medicines regulatory framework

Australian Acupuncture and Chinese Medicine Annual Conference Perth 2016

Lyndall Soper, Assistant Secretary Complementary and Over-the-Counter Medicines Branch Medicines Regulation Division Therapeutic Goods Administration 20-22 May 2016

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Overview

  • The Complementary Medicines regulatory

framework

  • Traditional Chinese Medicines within the

regulatory framework

  • The future of Complementary Medicine

regulation

Overview of the Complementary Medicines regulatory framework 1

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The challenge

Managing industry innovation with consumer safety Industry

Minimal regulatory burden

Consumer

Overview of the Complementary Medicines regulatory framework 2

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Therapeutic Goods Administration

  • Established in 1989
  • Part of the Department of

Health

  • Safeguard health of Australian

public

  • Regulates therapeutic goods

(medicines and medical devices)

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What is a Complementary Medicine?

Complementary Medicines

Herbal Medicines Aromatherapy Products Homoeopathic Medicines Nutritional Supplements Vitamins and Minerals Traditional Medicines

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Why do we regulate complementary medicines?

  • Safeguard the health of the Australian public
  • Safe, high quality medicines
  • Manage adverse events

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What the TGA does not regulate

  • Practitioners
  • Cosmetics
  • Health insurance
  • Veterinary medicines
  • Extemporaneously

compounded complementary medicines

  • Food products

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Regulatory Framework for Complementary Medicines

  • Therapeutic Goods Act 1989 (the Act)
  • Therapeutic Goods Regulations 1990
  • Poisons standard

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A risk-based approach to regulation

Australian Register of Therapeutic Goods (ARTG) Listed medicines AUST L

  • Low level indications
  • Low risk ingredients
  • No premarket evaluation
  • f product

Registered medicines AUST R Premarket evaluation of:

  • quality
  • safety
  • efficacy

Lower risk Higher risk

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Overview of the Complementary Medicines regulatory framework 9

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Listed Medicines Regulatory Framework

Medicine listed

  • n the ARTG

Post-market compliance

Pre- approved ingredients

Good manufacturing practice

(GMP) Low level therapeutic claims

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Applying for a listed medicine

  • Electronic application:

– Electronic Listing Facility (ELF)

  • Easy access to market:

– Supply within 48 hours of applying

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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

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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)

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Good Manufacturing Practice (GMP)

Pre-approved ingredients GMP Low level therapeutic claims

  • Licence or clearance

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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

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Listed Medicines Compliance Framework

Pre- approved ingredients

Good manufacturing practice

(GMP) Low level therapeutic claims

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Medicine listed

  • n ARTG

Post-market Compliance review

Fully compliant

Cancelled from ARTG

Non compliant

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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

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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

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Registered Complementary Medicines Regulatory Framework

Quality Safety Efficacy

  • If the medicine cannot be listed then it may

need to be Registered

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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
  • f China

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Scientific Indications - Evidence

Scientific evidence:

  • Quantifiable data

Sources of evidence include:

  • Clinical studies
  • Peer-reviewed published articles
  • Pharmacopoeias
  • Systematic reviews

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Traditional Chinese Medicines within the regulatory framework

  • Adulteration
  • Aristolochic acids
  • Homeopathic ingredients

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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.

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Traditional Chinese Medicines within the regulatory framework

  • Adulteration
  • Aristolochic acids
  • Homeopathic ingredients

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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

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Guidance material

  • Australian Regulatory

Guidelines for Complementary Medicines (ARGCM)

  • Evidence Guidelines
  • twitter.com/tgagovau

.gov.au

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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

  • https://www.tga.gov.au/report-perceived-breach-or-questionable-practices

Reporting adverse effects

  • https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase

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