regulatory reform: are we heading in the right direction?...competitiveness, and regulatory...

Regulatory Reform: Are we heading in the right direction?

Trisha Garrett, Assistant Secretary, Complementary and OTC Medicines Branch 11 November 2015

Where are we going?

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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

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1. TGA restructure

Regulatory Services Group Structure

Deputy Secretary

TGA Office of Chemical Safety Office of Gene Technology Regulator

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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 Services and Improvement Branch

Regulatory Practice, Education and Compliance

Branch

1. TGA restructure

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)

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

Government commitment: Broadly, there are two types of reforms:

• Improving processes within existing framework

• Policy change

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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 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.

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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.

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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 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

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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

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

Key performance indicators

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

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

Implementation of the new framework • 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

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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

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3. Improving Complementary Medicines processes within the existing framework

International Work Sharing 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.

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Ingredients Section 26BB inserted into Act, 2009 • Single source of truth • All ingredients (active and

excipient) and requirements • Publicly accessible • Simple • Transparent

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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.

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3. Improving Complementary Medicines processes within the existing framework

Changes to the Regulations • 26BB Consequential changes

• Therapeutic Goods Regulations:

– Schedule 4 (Eligibility for listing)

– Schedule 9 (Fees)

– Regulation 3AA (RASML)

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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

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OTC BPR

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• Improved target times for OTC evaluations

• Updated guidance material

• Revised fees commencing 1 January 2016

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)

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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

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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

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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

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ARE WE THERE YET?

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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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