TGA presentation given at ASMI Annual Conference, 11 November 2015

Presentation: Regulatory Reform - Are we heading in the right direction?

25 November 2015

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Presentation

  • Presented by: Trisha Garret, Complementary and Over the Counter Medicines Branch, Therapeutic Goods Administration
  • Presented at: Australian Self Medication Industry (ASMI) Annual Conference, 11 November 2015
  • Presentation summary: This presentation provided an overview of recent and upcoming regulatory reforms.

Transcript

Show transcript for this slideshow

Regulatory Reform - Are we heading in the right direction?

Trisha Garrett
Assistant Secretary, Complementary and OTC Medicines Branch

ASMI Annual Conference, 11 November 2015

Slide 1 - Where are we going?

Slide 2 - TGA Update

  1. TGA restructure
  2. Government agenda on “Innovation and Competitiveness, and regulatory reform"
  3. Improving Complementary Medicines processes within the existing framework
  4. Complementary and OTC medicines manufacturing
  5. Labelling and Packaging review

Slide 3 - Regulatory Services Group Structure

1. TGA Restructure

Regulatory Services Group Structure chart

The above structure chart is represented below in bullet point form.

  • Deputy Secretary
    • TGA
    • Office of Chemical Safety
    • Office of Gene Technology Regulator

Slide 4 - TGA Structure

1. TGA Restructure

Therapeutic Goods Administration structure chart

The above structure chart is represented below in bullet point form.

  • TGA
    • Medicines Regulation Dibision
      • Complementary and OTC Medicines Branch
      • Pharmacovigilance and Special Access Branch
      • Prescription Medicines Authorisation Branch
      • Scientific Evaluation Branch
    • Medical Devices and Producot Quality Branch
      • Laboratories Branch
      • Manufacturing Quality Branch
      • Medical Devices Branch
    • Regulatory Practice and Support Division
      • Regulatory Engagement and Planning Branch
      • Regulatory Practice, Education and Compliance Branch
      • Regulatory Services and Improvement Branch

Slide 5 - Medicines Regulation Division

1. TGA Restructure

Medicines Regulation Division structure chart

The above structure chart is represented below in bullet point form.

  • Medicines Regulation Division
    • PMAB (Prescription Medicines Authorisation Branch)
    • COMB (Complementary and OTC Medicines Branch)
      • Management and Operations
      • Complementary Medicines Evaluation
      • Listing Compliance
      • Over-the-Counter
    • PSAB (Pharmacovigilance and Special Access Branch)
    • SEB (Scientific Evaluation Branch)

Slide 6 - Government commitment:

2. Government agenda on "Innovation andCompetitiveness, and regulatory reform"

Broadly, there are two types of reforms:

  • Improving processes within existing framework
  • Policy change

Slide 7 - Review of Medicines and Medical Devices Regulation – Stage 1

2. Government agenda on "Innovation andCompetitiveness, and regulatory reform"

  • The first Report of the Review of Medicines and Medical Devices Regulation was publicly released on 24 June 2015.
  • 32 recommendations against a set of principles and frameworks and suggests potential changes to legislation, processes and supporting infrastructure necessary to improve the way medicines and medical devices are regulated in Australia.

Slide 8 - Review of Medicines and Medical Devices Regulation

2. Government agenda on "Innovation and Competitiveness, and regulatory reform"

  • The Department of Health is seeking input and feedback from stakeholders across industry associations, consumer groups, and clinical and professional groups.
  • The purpose of the forums is to engage with stakeholders to understand your views on the benefits and impacts of the recommendations to help inform the Department of Health’s advice to Government.

Slide 9 - Review of Medicines and Medical Devices Regulation

2. Government agenda on “Innovation and Competitiveness, and regulatory reform”

  • Government response to recommendations are expected towards the end of 2015.
  • Publication of Part 2 relating to complementary medicines and advertising will be announced by Government.
  • More information: health.gov.au – Expert-Review-of-Medicines-and-Medical-Devices-Regulation

Slide 10 - New Regulator Performance Framework

2. Government agenda on "Innovation and Competitiveness, and regulatory reform"

  • A new Regulator Performance Framework was released in November 2014, comprising six outcomes-based key performance indicators (KPI’s)
  • The Framework also comprises measures of good regulatory performance to be used by all regulators to assess their achievement of the KPIs
  • Processes exist within the Framework for external validation of regulators’ self-assessments, e.g. annual certification and targeted external review every three years

Slide 11 - Key performance indicators

2. Government agenda on "Innovation and Competitiveness, and regulatory reform"

  1. Regulators do not unnecessarily impede the efficient operation of regulated entities
  2. Communication with regulated entities is clear, targeted and effective
  3. Actions undertaken by regulators are proportionate to the regulatory risk being managed
  4. Compliance and monitoring approaches are streamlined and coordinated
  5. Regulators are open and transparent in their dealings with regulated entities
  6. Regulators actively contribute to the continuous improvement of regulatory frameworks

Slide 12 - Implementation of the new framework

2. Government agenda on "Innovation and Competitiveness, and regulatory reform"

  • Consultation with TGA-Industry Consultative Committee
  • Approval by the Minister for Health following agreed formal stakeholder consultation
  • Develop any necessary data capture processes
  • The first assessment period is the 2015-16 financial year
  • The first report will be delivered in August 2016

Slide 13 - Improving processes within existing framework

3. Improving Complementary Medicines processes within the existing framework

  • International work sharing
  • Permissible ingredients for use in listed medicines - Implementation of 26BB of the Therapeutic Goods Act 1989
  • Complementary Medicines Business Process Reform
  • Over-the-Counter Business Process Reform

Slide 14 - International Work Sharing

3. Improving Complementary Medicines processes within the existing framework

The TGA continues to work with partner agencies on a range of activities: Australia, Canada, Singapore and Switzerland to identify opportunities forthe evaluation of the safety of new substances; and New Zealand and Canada on OTC medicines.

Slide 15 - Ingredients

Section 26BB inserted into Act, 2009

  • Single source of truth
  • All ingredients (active and excipient) and requirements
  • Publicly accessible
  • Simple
  • Transparent

Slide 16 - Ingredients list:

3. Improving Complementary Medicines processes within the existing framework

Therapeutic Goods Permissible Ingredients Determination 2015 (No 1)

The 26BB list includes all relevant requirements for ingredients for listed medicines.

Slide 17 - Changes to the Regulations

3. Improving Complementary Medicines processes within the existing framework

  • 26BB Consequential changes
  • Therapeutic Goods Regulations:
    • Schedule 4 (Eligibility for listing)
    • Schedule 9 (Fees)
    • Regulation 3AA (RASML)

Slide 18 - CM BPR – new portal and processes

  • Business Process Reform
  • Expert Review of Medicines and Medical Devices

Partnership to achieve high quality applications and more predictable timeframes

Slide 19 - OTC BPR

  • Improved target times for OTC evaluations
  • Updated guidance material
  • Revised fees commencing 1 January 2016

Slide 20 - GMP Inspections: risk based framework

4. Complementary and OTC Medicines Manufacturing

New risk framework:
  • Product and manufacturing risk matrix will be adjusted to reflect TGA experience (e.g. listed medicines will be Low Risk)
  • Compliance history – reduced reinspection frequencies for manufacturers with repeat A1 ratings
  • Reinspection frequencies – different for registered vs listed medicines (listed medicines up to 48 months for repeat A1 ratings)

Slide 21 - GMP Inspections: risk based framework

4. Complementary and OTC Medicines Manufacturing

Complementary Medicines manufacturing quality guidelines
  • TGA Industry Working Group on GMP to develop guidelines on how TGA will apply PIC/S guidelines to take into account issues specific to the Australian market and/or specific product types
  • Currently working on Complementary Medicines and Sunscreen specific matters

Slide 22 - Medicines labelling review

5. Labelling and Packaging review

Aims to address problems:
  • Expression of active ingredients
  • Allergies to excipients
  • CMs and interactions with other medicines

Slide 23 - Current status: Labelling review

5. Labelling and Packaging review

  • Finalised review of submissions received during the 2014 consultation
  • Revised draft labelling Order and Guidance
  • "What's different" document
  • Decision RIS

Slide 24 - Are we there yet?

Slide 25 - Conclusion: already on our way

  • International harmonisation and information sharing
  • Streamlining of business processes
  • Review will inform future reforms
  • Updated guidance

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