Update on Reforms to the Regulatory Framework for Complementary - - PowerPoint PPT Presentation

Update on Reforms to the Regulatory Framework for Complementary Medicines

Dr Mark McDonald Assistant Secretary Complementary and OTC Medicines Branch Medicines Regulation Division, TGA

CMA Conference, 26 October 2017

Review of Medicines and Medical Devices Regulation

• In March 2015 the Expert Panel conducting the Medicine and

Medical Devices Review 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 reforms outlined in the Response will be implemented over the next 12 to 24

months

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5 streams of work

Stream 1 Stream 2 Stream 3

Increased predictability for industry

Stream 4 Stream 5

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Enhancing the listing framework Increased flexibility for sponsors and improving the evidence base Improving transparency for consumers Enhanced post-market monitoring and compliance actions

Stream 1: Enhancing the listing framework

Recommendation Government Response Recommendation 34: Capacity to refuse to list Supports the intent of the recommendation Recommendation 37: Online searchable catalogue of permissible ingredients Accepts the recommendation Recommendation 38 : Establish a list of permitted indications Accepts the recommendation

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Recommendation 38: Permitted Indications

Recommendation 38

The Panel recommends that the TGA establishes the list of Permitted Indications, from which sponsors must exclusively draw, for listed medicinal products in the ARTG.

Government response

The Commonwealth accepts Recommendation 38, noting that implementation of the list of Permitted Indications will require legislative change and will be subject to consultation with consumers, sponsors and health professionals.

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Recommendation 38: Key Features

• Sponsors listing a medicine on the ARTG will only be able to use indications from

a permitted indications list

• Removal of “free text” box in the listed medicines application system
• Indications will not have to be ‘word for word’ on the medicine label
• Sponsors will be able to apply for new indications (fee applicable)
• Permitted indications must be “low level indications” that only refer to health

maintenance, health enhancement or self-treatable / self-manageable conditions.

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Development of the permitted indications list

• A draft list of permitted indications has been published on the TGA website
• Stakeholders have the opportunity to review, comment and propose new

indications

• Supporting materials have been published to help stakeholders understand how

regulatory requirements for listed medicines will change

• The list is open for comment until 31 October 2017
• New indications proposed after this time will incur a fee.

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Stream 2: Increased flexibility for sponsors and improving the evidence base

Recommendation Government Response Recommendations 35/36: Continue to evaluate ingredients on safety, evidence and quality with two new methods for assessment of ingredients Accepts both recommendations Recommendation 39: Three pathways for inclusion of Listed medicines on the ARTG Accepts the recommendation Recommendation 40: Develop two new pathways for Registered complementary medicines Accepts the recommendation

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Recommendations 35: Expanding the sources

• f evidence – Ingredient Assessment

Recommendation 35

The Panel recommends that the TGA continues to evaluate ingredients for use in listed medicinal products and should continue to give consideration to:

• A. the safety of the proposed ingredient
• B. working with stakeholders to identify a broader range of appropriate sources of

evidence

• C. the quality of the proposed ingredients

Government response

The Commonwealth accepts Recommendation Thirty-Five, noting that stakeholders were in favour of the TGA continuing to evaluate ingredients for use in listed medicinal products.

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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

§ Sources could include: ‒ Herbal monographs, scientific monographs, and adverse event databases ‒ Pharmacopoeial monographs (e.g. Korean Pharmacopoeia)

• Additional sources of evidence that meet the above criteria at the time of

submission.

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Proposed Criteria for acceptable sources of evidence for de novo assessment

• The source of evidence must be in English and consistent with the current body of

knowledge

• The source of evidence must be peer reviewed or from reliable publishing sources and

any conflicts of interest must be identified

• The way in which the submitted evidence source is developed must be consistent with

internationally recognised guidelines and standards

• The ingredient, form, dose and route of administration described in the source of evidence

must be equivalent to that being applied for .

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Recommendations 36 and 40: Use of comparable

• verseas regulator reports

Recommendation 36

The Panel recommends that a sponsor seeking to have a new ingredient assessed by the TGA for use in listed medicines, is able to either:

• A. submit data relating to the safety and quality of the proposed ingredient for use in listed

medicinal products for de novo assessment by the NRA or

• B. submit an un-redacted evaluation report from a comparable overseas regulator

Government response

The Commonwealth accepts Recommendation Thirty-Six, as it will provide additional flexibility for applicants looking to apply for assessment of new ingredients for use in listed medicines.

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Recommendation 36 and 40: Use of comparable

• verseas regulator reports

Recommendation 40

The Panel recommends that where a sponsor seeks to include a complementary medicinal product in the ARTG that the sponsor is able to do so utilising registration Pathways One or Two, namely

• A. submission of a complete dossier for de novo assessment
• B. submission of an un-redacted evaluation report from a comparable overseas NRA

Government response

The Commonwealth accepts Recommendation Forty, as it will increase flexibility for sponsors seeking to register a complementary medicine in the ARTG.

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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
• verseas assessment.

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Key features: Use of comparable overseas regulator reports

• Criteria developed to confirm that there is sufficient similarity between a source
• f evidence and TGA requirements
• A list of comparable overseas regulators will be published on the TGA website
• Shorter assessments timeframes where reports from comparable overseas

regulators are used.

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Proposed Criteria for comparable overseas regulators and their reports Stage one – Does the framework align with TGA’s

• The regulator must be an internationally recognised regulatory authority with an

established track record of approving low risk food, chemical or medicinal substances

• The regulator must have a transparent system for regulatory decision-making
• The overseas regulator must use internationally accepted scientific standards and

guidelines

• We must have, or be able to establish, a relationship with the overseas regulator.

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Proposed Criteria for comparable overseas regulators and their reports – Stage two - suitability of evaluation reports from overseas regulators

Comparability of the medicine or ingredient

• The formulation, dose, route of administration and/or indications must be equivalent to that

being applied for Nature of the assessment reports

• Use of internationally accepted guidelines and standards
• The report(s) must be un-redacted, complete, and written in English
• We must be able to use any supplementary information to publish general information

about the safety, quality or efficacy of the medicine, noting that commercial in confidence information will not be disclosed

• The report must be a de novo assessment made by an overseas regulator.

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Recommendation 39: Three assessment pathways for complementary medicines

Recommendation

The Panel recommends that there be three options by which sponsors may seek entry into the ARTG of complementary medicinal products and other listed medicinal products for supply in Australia.

Government response

The Commonwealth accepts the recommendation, noting that legislative amendments are required to implement Option Two. Implementing this recommendation would increase transparency for consumers, provide additional flexibility for sponsors and support innovation.

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Recommendation 39: Key features

• A new product assessment pathway sitting between the existing Listed medicine (low

risk) and Registered medicine (high risk) pathways (New Pathway)

• Access to higher-level claims (e.g. ‘Relieves arthritis’) than standard listed medicines

(e.g. ‘Helps relieve joint pain’)

• Claims must be supported by appropriate scientific evidence
• TGA evaluates the evidence for efficacy before a product is listed
• An option to include a ‘claimer’ on all promotional material stating the medicine has been

independently assessed.

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Recommendation 39: Next steps

• Design of the claimer is currently underway
• The pilot phase for the new pathway will begin in January 2018 ahead of full

implementation in 2019 – Expressions of interest via the TGA website late 2017 – Opportunity to ensure proposed data requirements, fees and timeframes are correct

• Evidence guidelines for product assessments will be

developed and consulted on.

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Stream 4: Increased predictability for industry

Recommendation Government Response Recommendation 41: Develop additional legislative timeframes Accepts the recommendation Recommendation 42: M anagement of variations Accepts the recommendation Recommendation 47: Expand review and appeal rights Supports the intent of the recommendation Recommendation 50: Incentives for innovation of complementary medicines Accepts in principle

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Recommendation 41 – Legislative timeframes

Recommendation

In consultation with industry, develop legislative timeframes for the

• assessment of new ingredients for use in listed medicinal products
• publication of finalised compositional guidelines for newly approved

ingredients for use in listed medicinal products, where appropriate

• assessment of medicinal products listed under the new pathway
• registration of complementary medicines.

Government response

The Commonwealth accepts Recommendation Forty-One, noting that development of legislative timeframes will be subject to further consultation with stakeholders.

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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

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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.

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Recommendation 41 – New Application categories

Example: Application categories for complementary medicine ingredients

• IN1- Analysis of safety and quality based on reports from comparable overseas

regulators, which meet the minimum data requirements

• IN2 - Evaluation of safety based on reports from comparable overseas regulators and

de novo evaluation of quality

• IN3 - Evaluation of quality based on international evaluation reports or an accepted

monograph and de novo evaluation of safety

• IN4 - Full de novo evaluation of safety and quality.

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Recommendation 41: Ingredient timeframes

• Application categories for complementary medicine ingredients:

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Recommendation 41 – Example New Fee structure

Proposed fees for assessment of new ingredients

Note: the same fees will apply for some application categories as use of reports from comparable

• verseas regulators are a new process that will not necessarily result in a reduction in work effort for

the TGA. Reduced timeframes will apply.

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Phased implementation 2017 - 2019

In 2017

– Online searchable catalogue of permitted ingredients – Review and appeal rights for ingredient assessment

By 2018

– Permitted Indications – New assessment pathways for registered complementary medicines and new ingredients – Risk-based approach to medicine variations

By 2019

– The New Pathway – Label ‘claimer’

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MMDR consultations

• Targeted stakeholder consultations commenced October 2016
• Public consultations throughout 2017
• The proposed reforms arising from recommendations 38, 39, 45

and 50 are addressed in our first public consultation paper

• Outcomes from this consultation are on the TGA website.

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Latest Consultation

• The TGA are now seeking comments from stakeholders on reforms that

will support the new assessment pathway

• The Consultation on Business Process

Improvements supporting Complementary Medicines Assessment Pathways opened

• n 26 September and will close 7 November.

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The consultation includes five elements:

• 1. Business processes to support the introduction of the third assessment pathway

(Rec 39).

• 2. Use of reports from comparable overseas regulators (Rec 36 and 40).
• 3. Broadening the range of acceptable sources of evidence for the assessment of

ingredients proposed for use in listed medicines (Rec 35).

• 4. Introduction of legislated timeframes and a new fee structure for complementary

medicine and ingredient assessment (Rec 41).

• 5. Enhancing the post-market compliance monitoring scheme for listed complementary

medicines (Rec 49).

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Next steps

• Further Consultation
• Transitional arrangements
• Sponsor education
• Updated guidelines

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Questions

32

Find out more:

www.tga.gov.au/mmdr

MMDR.consultation@health.gov.au