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TGA presentation given at the Capsig NSW - Complementary medicines - revival, 25 March 2015

20 April 2015

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Presentation

  • Presented by: Yasmin Mollah, Assistant Director, Listing Operations and Angeliza Querubin, Pre-Market Assessment Section, Complementary medicines branch, TGA
  • Presented at: Capsig NSW - Complementary medicines - revival, 25 March 2015
  • Presentation summary: This presentation provided an overview of the regulation of complementary medicines.

Transcript

The regulation of complementary medicines

Yasmin Mollah
Assistant Director, Listing Operations

Angeliza Querubin
Pre-Market Assessment Section, Complementary medicines branch, TGA

Capsig NSW - Complementary medicines - revival, 25 March 2015

Slide 1 - Therapeutic Goods Administration

What do we do?

  • Established in 1989
  • Department of Health of Australia
  • Safeguard health of Australian public
  • Regulates therapeutic goods
  • Medicines and medical devices

Slide 2 - TGA structure

Therapeutic Goods Administration organisational structure

  • National Manager
    • Market Authorisation Division
      • Medicines Authorisation Branch
      • Complementary Medicines Branch
      • Devices Authorisation Branch
      • Scientific Evaluation and Special Product Access Branch
    • Monitoring and Compliance Division
      • Regulatory Compliance Branch
      • Manufacturing Quality Branch
      • Laboratories Branch
      • Post-market Surveillance Branch
    • Regulatory Support Division
      • Regulatory Business Services Branch
      • Regulatory knowledge and Technology Services Branch
      • Regulatory Engagement, Education and Planning Branch
      • Regulatory Business Improvement Branch
      • Regulatory Legal Services Branch

Slide 3 - Complementary Medicines Branch

Complementary Medicines Branch structure

  • Market Authorisation Group
    • MAB (Medicines)
    • CMB (Complementary Medicines)
      • Regulatory Reform & Coordination
      • Pre-market Assessment
      • Listing Compliance
      • Listing and Operations
    • DAB (Medical Devices)
    • SESPAB (Scientific Evaluation)

Slide 4 - What are Complementary Medicines?

Diagram of what are complementary medicines

  • Complementary medicines
    • Herbal medicines
    • Traditional medicines
      • Ayurvedic medicines
      • Traditional Chinese medicines
      • Other traditional medicines
    • Vitamins and minerals
    • Nutritional supplements
    • Homeopathic medicines
    • Aromatherapy products

Slide 5 - The TGA does not regulate:

  • Practitioners, such as naturopaths, traditional Chinese Medicine practitioners
  • Complementary medicines that are dispensed or extemporaneously compounded by healthcare practitioners for individual patients
    • Regulated at a State/Territory level

Slide 6 - Risk based regulation of medicines

Australia has a risk-based approach with a two-tiered system for the regulation of all medicines, including complementary medicines

Lower risk medicines

  • listed on the Australian Register of Therapeutic Goods
  • AUSTL

Higher risk medicines

  • registered on the ARTG
  • AUSTR

Listed products are lower risk and Registered products are higher riskSlide 7 - Risk based approach

Registered

  • Pre-market evaluation
  • Medicine focussed
  • May have restrictions on access
  • Higher level claims
  • Identified by "AUST R" number

Listed

  • No restrictions on access
  • Low and medium level claims
  • May have restrictions: quantities, dosage form, route of admin, plant part, etc
  • Enter ARTG via the Electronic Listing Facility (ELF)
  • Sponsor makes certifications against requirements
  • Evidence for claims monitored 'post-market'
  • Id. by "AUST L" number

Slide 8 - Determinants of risk

  • Ingredients
  • Dosage form
  • Indications and claims
  • Significance of side effects
  • Effects of prolonged use or inappropriate self-medication

Slide 9 - Is it eligible for Listing?

Eligibility requirements
Approved ingredients Preparation not in SUSMP Qty restrictions not exceeded Not required to be sterile
Herbal ingredients meet definition of "herbal substance" Indications do not refer to disease / condition in Appendix 6 of TGAC
Sponsor certifies medicine eligible for Listing
ELF validation can pick up some 'ineligibility'
Listing

Slide 10 - Listed Medicines Regulatory Framework

Unique regulatory framework

  • Evidence sourced from open literature
  • Regulatory framework consistent with low risk medicines

Listed on ARTG

  • Streamlined online application and validation process
  • Sponsor certify meets legislation requirements
  • No premarket efficacy evaluation

Quick and easy market access

Pre-approved ingredients

Compliance review

Fully compliant > Retail supply to Australian market place > Market share established

Non compliant > ??? Cancelled from ARTG

Flow diagram showing Listed medicines regulatory framework

Slide 11 - Post-listing regulatory activities

Risk based regulatory approach includes:

  • desk-based audits of listed medicines
  • laboratory testing of products and ingredients
  • surveillance in the marketplace
  • monitoring of adverse reactions
  • recalls procedure
  • audit of manufacturing sites
  • controls for advertising

Slide 12 - Type of Compliance Reviews for LMs

Investigations

  • Triage of complaints into highest priority > target review

Target reviews

  • Often triggered from complaint or intelligence report
  • Specific information is reviewed to address concerns
  • Comprehensive evidence reviews

Random reviews

  • Newly LMs are randomly selected
  • Standard set of information is reviewed

Slide 13 - Compliance review

Review

  • Evidence
    • Claims / indications: relevance, quality
  • Labelling
    • Correct format
    • Presentation
    • Advisory statements
  • Manufacturing
    • Licence / valid clearance
    • Finished Product Specifications

Slide 14 - Listing compliance review process

Sponsor review listing & address issues

  • Medicine listed on ARTG
  • Compliance review request for information (s31 of Act )
  • Assessment of information against relevant legislative requirements
    • Direct cancellation ss30(1C) or (1A)
      • Cancel medicine from ARTG
    • compliance issues identified
    • Propose to Cancel (P2C)
      • Cancellation ss30(2)
        • Cancel medicine from ARTG
      • Address all non-compliance issues of P2C
        • Medicine remains on ARTG
  • Fully compliant
    • Medicine remains on ARTG

Slide 15 - Does the indication match the evidence?

  • Pyramid diagram of increasing quality from Expert opinion, testimonials > Observational and case studies > Uncontrolled studies / monographs > Small RCT > ReviewsScientific indications are supported by scientific evidence
  • Traditional indications are derived from a tradition of use within a paradigm
  • Format of 2 types of indications are different on the medicine label
  • According to the current Evidence Guidelines1
    • Is the evidence relevant?
  • Equivalent doses; plant part
    • Is it high quality evidence?
  • Systematic reviews, methodological sound
    • Is it a balanced view?
  • Positive evidence > equivocal/negative

Reference

  1. Guidelines for levels and kinds of evidence to support indications and claims (2011)

Slide 16 - Traditional use - Indications & evidence

  • Evidence of Traditional Use:
    • well-established tradition of use for its intended purpose >75 years and includes:
      • how it has been used during that time
      • the continuity of its use; and
      • the geographical extent of its use.
  • Example of traditional indication:
    • Traditionally used in Western herbal medicine to relieve nasal congestion
  • Sources include:
    • National formularies
    • materia medica
    • official pharmacopoeias; and
    • monographs

Slide 17 - Evidence guidelines

Slide 18 - Registered complementary medicines

  • Higher risk than listed medicines based on the ingredients and/or therapeutic indications
  • identified on the label by 'AUST R' followed by a number
  • Medicines must be registered on ARTG, where they:
    • Don't solely comprise ingredients permitted for use in listed medicines
    • Contain an ingredient subject to the conditions of Poisons Standard e.g. Pharmacist Only vitamins/minerals must be registered
    • Are required to be sterile
    • Have indications that make higher level claims that are not allowed in listed medicines
  • Registered complementary medicines may be subject to the conditions of a Schedule of Poisons Standard

Slide 19 - Registered complementary medicines

  • Pre-market evaluation is undertaken to establish quality, safety and efficacy of the medicine prior to approval for entry on the ARTG
  • Data requirements and evaluation are consistent with other OTC or prescription medicines
  • Evaluation includes determining whether the medicine complies with all applicable legislative requirements
  • Application data typically follows scheme used in the Common Technical Document (CTD), an internationally-agreed format for approval of new drugs adopted by TGA in 2004

Slide 20 - Registered medicines - Safety & efficacy data overview

  • Literature search strategy
  • History and pattern of human use
  • International regulatory status
  • Pharmacodynamics, pharmacokinetics, safety pharmacology, drug interactions
  • Toxicology: acute, chronic/subchronic, genotoxicity, carcinogenicity, reproductive & developmental etc.
  • Clinical trials
  • Adverse event reports in Australia and overseas

Slide 21 - Registered medicines - Quality data overview

  • Structural formula of the ingredient or components
  • Physiochemical and other relevant properties
  • Manufacturing details
  • Characterisation of ingredient or components
  • Control of substance: specifications, analytical procedures, batch certificate of analysis, justification of specifications
  • Reference standards
  • Stability data
  • Container/closure system

Slide 22 - 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 & affordable
    • Efficacious CMs with truthful advertising
    • Effective & transparent regulation of all medicines

Slide 23 - Guidance material

Recently updated

  • Australian Regulatory Guidelines for Complementary Medicines (ARGCM)

Slide 24 - Questions

Subscribe to updates

Information on reforms: Complementary medicines reforms

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