Presentation: Overview of the TGA's Complementary Medicine ... is a Complementary Medicine? Complementary Medicines . Herbal Medicines ... • audit of manufacturing ... Overview of

  • View
    219

  • Download
    4

Embed Size (px)

Text of Presentation: Overview of the TGA's Complementary Medicine ... is a Complementary Medicine?...

  • 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

  • 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

  • The challenge Managing industry innovation with consumer safety

    Industry

    Minimal regulatory

    burden

    Consumer

    Overview of the Complementary Medicines regulatory framework 2

  • Therapeutic Goods Administration

    Established in 1989 Part of the Department of

    Health Safeguard health of Australian

    public Regulates therapeutic goods

    (medicines and medical devices)

    Overview of the Complementary Medicines regulatory framework 3

  • What is a Complementary Medicine?

    Complementary Medicines

    Herbal Medicines

    Aromatherapy Products

    Homoeopathic Medicines Nutritional Supplements

    Vitamins and Minerals

    Traditional Medicines

    Overview of the Complementary Medicines regulatory framework 4

  • Why do we regulate complementary medicines? Safeguard the health of the Australian public

    Safe, high quality medicines

    Manage adverse events

    Overview of the Complementary Medicines regulatory framework 5

  • What the TGA does not regulate

    Practitioners Cosmetics Health insurance Veterinary medicines Extemporaneously

    compounded complementary medicines

    Food products

    Overview of the Complementary Medicines regulatory framework 6

  • Regulatory Framework for Complementary Medicines

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

    Overview of the Complementary Medicines regulatory framework 7

  • 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

    of product

    Registered medicines

    AUST R

    Premarket evaluation of: quality safety efficacy

    Lower risk Higher risk Overview of the Complementary Medicines regulatory framework

    8

  • Overview of the Complementary Medicines regulatory framework 9

  • Listed Medicines Regulatory Framework

    Medicine listed on the ARTG

    Post-market compliance

    Pre-approved

    ingredients

    Good manufacturing

    practice (GMP)

    Low level therapeutic

    claims

    Overview of the Complementary Medicines regulatory framework 10

  • Applying for a listed medicine Electronic application:

    Electronic Listing Facility (ELF)

    Easy access to market: Supply within 48 hours of

    applying

    Overview of the Complementary Medicines regulatory framework 11

  • 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

    Overview of the Complementary Medicines regulatory framework 12

  • 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 doesnt 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)

    Overview of the Complementary Medicines regulatory framework 13

  • Good Manufacturing Practice (GMP)

    Pre-approved ingredients

    GMP

    Low level therapeutic

    claims

    Licence or clearance

    Overview of the Complementary Medicines regulatory framework 14

  • 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

    Overview of the Complementary Medicines regulatory framework

    15

  • Listed Medicines Compliance Framework

    Pre-approved

    ingredients

    Good manufacturing

    practice (GMP)

    Low level therapeutic

    claims

    Overview of the Complementary Medicines regulatory framework 16

    Medicine listed on ARTG

    Post-market Compliance

    review

    Fully compliant

    Cancelled from

    ARTG

    Non compliant

  • 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

    Overview of the Complementary Medicines regulatory framework 17

  • 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

    Overview of the Complementary Medicines regulatory framework 18

  • Registered Complementary Medicines Regulatory Framework

    Quality

    Safety

    Efficacy

    If the medicine cannot be listed then it may need to be Registered

    Overview of the Complementary Medicines regulatory framework 19

  • 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 Peoples Republic

    of China

    Overview of the Complementary Medicines regulatory framework 20

  • Scientific Indications - Evidence Scientific evidence:

    Quantifiable data

    Sources of evidence include: Clinical studies Peer-reviewed published articles Pharmacopoeias Systematic reviews

    Overview of the Complementary Medicines regulatory framework 21

  • Traditional Chinese Medicines within the regulatory framework

    Adulteration Aristolochic acids Homeopathic ingredients

    Overview of the Complementary Medicines regulatory framework 22

  • 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.

    Overview of the Complementary Medicines regulatory framework 23

  • Traditional Chinese Medicines within the regulatory framework

    Adulteration Aristolochic acids Homeopathic ingredients

    Overview of the Complementary Medicines regulatory framework 24

  • 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

    Overview of the Complementary Medicines regulatory framework 25

    http://www.health.gov.au/internet/main/publishing.nsf/Content/8ADFA9CC3204463DCA257D74000EF5A0/$File/Review%20of%20Medicines%20and%20Medical%20Devices%20-%20Recommendations_Accessible.pdf

  • Guidance material

    Australian Regulatory Guidelines for Complementary Medicines (ARGCM)

    Evidence Guidelines twitter.com/tgagovau .gov.au

    Overview of the Complementary Medicines regulatory framework 26

  • 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

    Overview of the Complementary Medicines regulatory framework 27

    mailto:complementary.medicines@tga.gov.aumailto:complementary.medicines@tga.gov.auhttps://www.tga.gov.au/report-perceived-breach-or-questionable-practiceshttps://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabasehttps://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase

  • Overview of the Complementary Medicines regulatory frameworkOverviewThe challengeTherapeutic Goods AdministrationWhat is a Complementary Medicine?Why do we regulate complementary medicines? What the TGA does not regulateRegulatory Framework for Complementary MedicinesSlide Number 9Slide Number 10Slide Number 11Applying for a listed medicine Pre-approved ingredientsWe are often asked why the TGA does not allow some TCM?Good Manufacturing Practice (GMP)Evidence for Listed MedicinesListed Medicines C