TGA presentation: Background and progress of complementary medicine reforms

Complementary medicines reforms to the sponsor education workshop given at Sydney, Melbourne, Brisbane, Canberra, November-December 2017

12 December 2017

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Presentation

  • Presented by: Michael Shum, Director, Complementary and OTC Medicines Branch
  • Presented at: Complementary medicine reforms information sessions
  • Presentation date: November / December 2017
  • Presentation summary: This presentation gives an overview and update of the progress of complementary medicine reforms.

Transcript

Complementary medicines reforms sponsor education workshops

Michael Shum
Director, Complementary and OTC Medicines Branch
Medicines Regulation Division, TGA

Slide 1 - Welcome introduction

Michael Shum – Director, Complementary Medicines Reforms, Complementary and OTC Medicines Branch

Dr Michael Gardner – Director, Complementary Medicines Evaluation Section, Complementary and OTC Medicines Branch

Slide 2 -Agenda

  • Overview and update of the progress of complementary medicine reforms – 30 minutes
  • Permitted indications – 75 minutes
    • Legislative overview
    • Transition arrangements
    • Applying for new indications
  • Break – 15 minutes
  • Assessed listed medicines pathway & Evidence guidelines – 60 minutes

Slide 3 - Review of Medicines and Medical Devices Regulation

  • In March 2015 the Expert Panel conducting the Medicine and Medical Devices Review (MMDR) made 19 recommendations to improve the regulatory controls for complementary medicines manufactured, supplied and/or exported from Australia
  • In September 2016 the Australian Government released its response and accepted/supported the intent of all recommendations
  • The majority of the reforms outlined in the Response will be implemented between 2018-2019.

Slide 4 - Five streams of work

5 streams of work are:

  1. Enhancing the listing framework
  2. Increased flexibility for sponsors and improving the evidence
  3. Improving transparency for consumers
  4. Increased predictability for industry
  5. Enhanced post-market monitoring and compliance actions

Slide 5 - Principles guiding complementary medicine reforms

  • Maintain confidence in TGA regulation of complementary medicines
  • The level of regulation of medicines is commensurate with risk
  • Transparency on the level of assessment undertaken by the TGA and avoid consumers being misled by medicine indications
  • Improve sponsor compliance with regulatory requirements
  • Clear guidance on application processes and requirements
  • Support innovation and increase the evidence base and the standard of evidence for complementary medicines
  • Enable higher level indications to be made for listed medicines where that medicine’s evidence has been evaluated by the TGA

Slide 6 - Implemented reforms

  • In March 2017, the online catalogue of ingredients approved for use in listed medicines was implemented.
  • From 1 July 2017, sponsors who lodge applications for evaluation of new ingredients for use in complementary medicines are able to apply for review and appeal of decisions relating to those assessments.

Slide 7 - Staged implementation – indicative timeframes

By 2018

  • Permitted Indications
  • Market exclusivity for newly approved ingredients for applications submitted from January 2018
  • Risk-based approach to medicine variations

By 2019

  • Assessed listed medicines pathway launched
  • Label ‘claimer’

Slide 8 - Consultations

  • Targeted stakeholder consultations commenced October 2016
  • Public consultations throughout 2017
  • Consultation outcome available at MMDR public consultation forecast on the TGA website
  • More consultation to come in 2018

Slide 9 - First consultation on complementary medicines

List of first consultation on complementary medicines. Including recommendation 38, 39, 45 and 50.

Recommendation 38

  • A list of permitted indications for lowest risk medicines

Recommendation 39

  • Introduce a three-tiered risk-based framework

Recommendation 45

  • Allow sponsors to claim their medicine has been assessed for efficacy

Recommendation 50

  • Incentivise industry innovation

Slide 10 - Consultation outcomes

  • Introduce permitted indications to limit the indications that can be made for listed medicines
  • Providing a 2 year period of protection for new ingredients approved for use in listed medicines
  • Introduction of a new pathway for assessed listed medicines will sitting between the existing listed and registered pathways
  • Further consultation required to finalise the label ‘claimer’

Slide 11 - Overview of complementary medicines reforms

Slide 12 - Second consultation on complementary medicines

Recommendation 35

  • Expanding the sources of evidence for ingredient assessments

Recommendation 36 and 40

  • Use of reports from comparable overseas regulators

Recommendation 41

  • Legislative timeframes for pre-market assessments

Recommendation 49

  • Enhanced post-market compliance scheme

Slide 13 - Key features: Acceptable sources of evidence for de novo assessment

  • Criteria developed to confirm that there is sufficient similarity between a source of evidence and TGA requirements
  • A list of acceptable sources of evidence will be published on the TGA website
  • The source of evidence must be in English, peer reviewed and consistent with the current body of knowledge. Any conflicts must be identified.
  • The way in which the submitted evidence source is developed must be consistent with internationally recognised guidelines and standards

Slide 14 - Recommendation 36 and 40 - Methods for assessment

Current situation

  • Only accept data for de novo assessment

Changes proposed under recommendations 36 and 40

  • Allow use of evaluation reports from comparable overseas regulators in addition to de novo assessment
  • Increased flexibility by allowing a combination of de novo and overseas assessment

Slide 15 - Recommendation 41: Key Features

  • Timeframes for premarket assessments will be included in the legislation
    • Applications will have different assessment timeframes depending on the information to be evaluate
    • Partial refund of fees if evaluation timeframes are not met
  • A standard application and evaluation process for all pre-market assessment

Slide 16 - Recommendation 41: Key Features

  • Introduction of new risk based application categories for
    • ingredient assessment
    • the assessed listed medicines pathway
    • registered medicines pathway
  • Application categories to allow for use of international evaluation reports and de novo assessment
  • A new fee structure that is commensurate with the amount of work required
    • the new structures moves away from a page count

Slide 17 - Consultation outcomes

  • The Consultation on Business Process Improvements supporting Complementary Medicines Assessment Pathways closed on 7 November 2017
  • 14 submissions received
  • Submissions will be analysed and outcomes reported back to the Minister
  • TGA's response to the consultation submissions will be published on the TGA website in the coming months
  • Responses indicate a general support for the proposed timeframes and application categories
    • some concern surrounding the fees and criteria for use of overseas reports
    • clarity sought on the legislated timeframes and submission process

Slide 18 - Next steps

  • Legislative amendments to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990
  • Further consultation
  • Sponsor education
  • Updated guidelines

Slide 19 - Questions

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