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TGA presentation: Complementary Medicines Australia Annual Conference, 15 September 2016

Presentation: What's happening in regulation?

21 September 2016


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The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: John Skerrit, Deputy Secretary for Health Products Regulation, Commonwealth Department of Health
  • Presented at: Complementary Medicines Australia Annual Conference
  • Presentation date: 15 September 2016
  • Presentation summary: This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.


What's happening in regulation?

John Skerritt
Deputy Secretary for Health Products Regulation
Commonwealth Department of Health

CMA Annual Conference - September 2016

Slide 1 - Health Products Regulation Group Structure

Health Products Regulation Group Structure

  • Department of Health Secretary
    • Health Products Regulation Group, Deputy Secretary
      • Principal Medical Adviser, Principal Legal and Policy Adviser
      • Medicines Regulation
        • Prescription Medicines Authorisation
        • Complementary and OTC Medicines
        • Pharmacovigilance and Special Access
        • Scientific Evaluation
      • Medical Devices and Compliance
        • Medical Devices
        • Laboratories
        • Manufacturing Quality
      • Regulatory Practice and Support
        • Office of Drug Control
        • Medicinal Cannabis
        • Drug Control
      • Regulatory Reforms

Slide 2 - TGA stakeholder survey 2016

  • A requirement for the Government's Regulator Performance Framework
  • 2810 responses: 449 health professionals, 65 consumers, 1628 from industry
  • Results remarkably positive in terms of trust and confidence in the regulator
    • 79 % of industry have high/very high confidence in TGA safeguards
    • 61 % of community/ consumer groups with 27 % ambivalent/ unsure
  • Users satisfied or very satisfied with TGA consultations (63%), exhibitions (75%) and information sessions (82%) respectively.
  • Main area for work is to TGA to engage more actively with consumers
    • They are aware of, and have a generally favourable perception of the TGA, but many unsure
    • Consumers also felt least engaged in TGA policy consultations

Slide 3

Bar graph showing some results from TGA stakeholder survey 2016

Slide 4

Bar graph showing how satisfied people are with the TGA website

Bar graph showing overall satisfaction with communicating with the TGA

Slide 5 - The review process

  • Two reports on medicines and devices and complementary medicines and advertising released during 2015
  • Review process included discussion papers, submissions and interviews with key stakeholders. Followed by stakeholder workshops and other meetings to get feedback
  • Department considered stakeholder feedback and advised Minister took her preferred position to Cabinet
  • Government intent released in May 2016 budget, and full response released in September 2016

Slide 6 - Overarching principles for regulation as endorsed by Government

  • The Australian Government retain responsibility for approving the inclusion of therapeutic goods in the ARTG
    • Rather than automatically accepting international approvals
    • However need to make much greater use of overseas evaluations
  • Need to introduce greater flexibility in approval pathways
  • TGA could more appropriately align level regulation with the actual risk posed by the products in certain areas

Slide 7 - Seven bundles of work agreed and costed

  1. Increasing Flexibility for Registration and Post-Market Processes for Medicines
  2. Increasing Flexibility for Approval and Enhanced Post-Market Monitoring of Medical Devices
  3. Increasing Flexibility for Pre-Market Approval and Increased Evidence of Efficacy of Complementary Medicines for Consumers
  4. Simplified and More Effective Regulation of Advertising
  5. Streamlined Regulation of Patient Access to Therapeutic Products
  6. Further Reviews
  7. Rationalisation of TGA Statutory Advisory Committees

Slide 8 - Complementary Medicines changes

  1. Streamline transparency and predictability of regulation:
    • Better regulatory guidance materials
    • Catalogue of approved ingredients
    • Introduce permitted indications for Complementary Medicines
    • Adopt/ develop evidence monographs
    • Right of review for applicant of TGA decisions on ingredients
    • Establish ingredient assessment timeframes
    • Continue stakeholder input through an advisory committee

Slide 9

  1. Increasing the transparency of evidence of efficacy for particular indications
    • Sponsors encouraged but not mandated to publish efficacy evidence
    • Greater education on what AUST-L means, but sponsors not required to publish a label disclaimer
    • A new class of complementary medicines with efficacy assessed by TGA prior to market authorisation. Sponsors would be allowed to make higher-level claims than listed CMs.
    • Closer linkage to advertising claims
  2. More use of overseas assessments for new ingredients

Slide 10

  1. Increased postmarket monitoring and compliance
    • More products to be subject to random and targeted post-market review
    • Timely information on products subject to post-market review
    • Intent of R 34 (TGA being able to refuse to list particular products) is able to be achieved through current mechanisms (allowing CMs to contain only permitted ingredients and targeted reviews by TGA of products immediately post-listing)
  2. Improving the competitiveness of the complementary medicines industry by providing incentives for innovation
    • Could include consideration of data protection; use of "listed-plus" pathway; and advice service for SMEs

Slide 11 - Increase use of risk-based approaches to manage medicine variations

  • Notification of variations to TGA where the variation does not impact quality, safety or efficacy of the product
    • Harmonise with the EMA approach
  • Assessment of the variation by TGA if the variation could impact safety, quality or efficacy
    • Focus specifically on the impacts of the variation

Slide 12 - Strengthening of post market monitoring: recommendations accepted

  • Better integration and timely analysis of available datasets (including matched de-identified data from PBS and MBS)
  • Electronic reporting of adverse events
  • Issue of potential Complementary Medicine interactions with prescription medicines highlighted
  • Enhanced information-sharing with overseas regulators

Slide 13 - Further reviews to be undertaken

  • Medicines Scheduling Policy Framework
  • Schedule 3 medicine advertising Guidelines
  • Review regulation of lower-risk medicines
    • Should low-risk products such as homeopathic and aromatherapy products be regulated as general consumer goods?
    • What about vitamins and mineral supplements?

Slide 14 - SME regulatory assistance and clearer regulatory guidance

  • Aim is to help small business navigate the "regulatory maze" through advice, guidance documents and workshops
  • Builds on work by TGA Regulatory Assistance Team
  • Would not replace detailed product-specific advice provided by regulatory consultants

Slide 15 - Other recommendations

  • Comprehensive review of the Therapeutic Goods Act and Regs - deferred
  • The Government review and enhance TGA's funding model – deferred
  • CMO to become decision maker (rather than TGA delegate) for all medicines and devices decisions – not accepted
  • Complementary medicines advisory committee - maintained

Slide 16 - Advertising of therapeutic goods

  • Advertising of therapeutic goods to the public continues to be regulated by TGA under a framework which includes an advertising code
  • Abolish mandatory pre-approvals of advertising, and move to a self-regulatory regime
  • New mechanism for managing complaints managed in a streamlined process through a single agency
  • Investigation and enforcement powers around advertising to be broadened
  • TGA to run sponsor education programs to assist in achieving compliance

Slide 17 - How will we pay for the reforms?

  • Government agreed that we could use TGA reserves (and 2015/16 surplus) to pay for cost of design of reforms and implementation of new systems
  • Separately a systematic evaluation of appropriate fees and charges will be needed:
    • For new (e.g. enhanced comp meds compliance) and existing activities
    • So fees and charges may change

Slide 18 - A great opportunity to implement some important reforms... but with some big challenges for TGA

Slide 19 - Having a wider variety of medicines and devices approval pathways available will add to complexity

Slide 20 - We are required to utilise international assessments much more widely… but what if other regulators are less driven to share?

Slide 21 - Yet... Stakeholder expectations are very high after years of waiting for reform

Slide 22 - Implementation and Governance

  • A broad plan for implementation over the next 2 years has been agreed by Government
  • We will also consult closely with stakeholders in developing the finer detail on implementation, including assessment of regulatory impacts and fees and charges
  • TGA has been empowered to work out much of the detail on how specific changes could be implemented
    • But we will need to go back to government for approval, in particular where changes to the TGA Act or Regulations are needed

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