Regulatory Reform: Are we heading in the right direction?

Transcription

1 Regulatory Reform: Are we heading in the right direction? Trisha Garrett, Assistant Secretary, Complementary and OTC Medicines Branch 11 November 2015

2 Where are we going? 2

3 Update 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 3

4 1. TGA restructure Regulatory Services Group Structure Deputy Secretary TGA Office of Chemical Safety Office of Gene Technology Regulator 4

5 1. TGA restructure TGA Structure TGA Medicines Regulation Division Complementary and OTC Medicines Branch Pharmacovigilance and Special Access Branch Prescription Medicines Authorisation Branch Scientific Evaluation Branch Medical Devices and Product Quality Division 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

6 1. TGA restructure Medicines Regulation Division PMAB (Prescription Medicines Authorisation Branch) COMB (Complementary and OTC Medicines Branch) PSAB (Pharmacovigilance and Special Access Branch) SEB (Scientific Evaluation Branch) Management and Operations Complementary Medicines Evaluation Listing Compliance Over-the-Counter 6

7 Government commitment: Broadly, there are two types of reforms: Improving processes within existing framework Policy change 2. Government agenda on Innovation and Competitiveness, and regulatory reform 7

8 2. Government agenda on Innovation and Competitiveness, and regulatory reform Review of Medicines and Medical Devices Regulation Stage 1 The first Report of the Review of Medicines and Medical Devices Regulation was publicly released on 24 June 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. 8

9 2. Government agenda on Innovation and Competitiveness, and regulatory reform Review of Medicines and Medical Devices Regulation 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. 9

10 2. Government agenda on Innovation and Competitiveness, and regulatory reform Review of Medicines and Medical Devices Regulation Government response to recommendations are expected towards the end of 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 10

11 2. Government agenda on Innovation and Competitiveness, and regulatory reform New Regulator Performance Framework 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 11

12 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 12

13 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 financial year The first report will be delivered in August

14 3. Improving Complementary Medicines processes within the existing framework Improving processes within 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 14

15 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 for the evaluation of the safety of new substances; and New Zealand and Canada on OTC medicines. 15

16 Ingredients Section 26BB inserted into Act, 2009 Single source of truth All ingredients (active and excipient) and requirements Publicly accessible Simple Transparent 16

17 3. Improving Complementary Medicines processes within the existing framework Ingredients list: Therapeutic Goods Permissible Ingredients Determination 2015 (No 1) The 26BB list includes all relevant requirements for ingredients for listed medicines. 17

18 Changes to the Regulations 26BB Consequential changes Therapeutic Goods Regulations: Schedule 4 (Eligibility for listing) Schedule 9 (Fees) Regulation 3AA (RASML) 3. Improving Complementary Medicines processes within the existing framework 18

19 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 19

20 OTC BPR Improved target times for OTC evaluations Updated guidance material Revised fees commencing 1 January

21 4. Complementary and OTC Medicines Manufacturing GMP Inspections: risk based framework 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) 21

22 4. Complementary and OTC Medicines Manufacturing GMP Inspections: risk based framework 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 22

23 5. Labelling and Packaging review Medicines labelling review Aims to address problems: Expression of active ingredients Allergies to excipients CMs and interactions with other medicines 23

24 5. Labelling and Packaging review Current status: Labelling review Finalised review of submissions received during the 2014 consultation Revised draft labelling Order and Guidance What s different document Decision RIS 24

25 ARE WE THERE YET? 25

26 Conclusion: already on our way International harmonisation and information sharing Streamlining of business processes Review will inform future reforms Updated guidance 26

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