TGA presentation: Complementary Medicines Regulatory (CMA) Annual Conference, 26 October 2017

Update on Reforms to the Regulatory Framework for Complementary Medicines

24 November 2017

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Presentation

  • Presented by: Dr Mark McDonald
  • Presented at: CMA Conference,
  • Presentation date: 26 October 2017
  • Presentation summary: Update on Reforms to the Regulatory Framework for Complementary Medicines.

Transcript

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

Slide 1 - 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

Slide 2 - 5 streams of work

image outlining the of the 5 streams of work.

5 streams of work are:

  1. Enhancing the listing framework
  2. Increased flexibility for sponsors and improving the evidence base
  3. Improving transparency for consumers
  4. Increased predictability for industry
  5. Enhanced post-market monitoring and compliance actions

Slide 3 - Stream 1: Enhancing the listing framework

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

Slide 4 - 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.

Slide 5 - Recommendation 38: Key Features

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.

Slide 6 - 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.

Slide 7 - Stream 2: Increased flexibility for sponsors and improving the evidence base

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

Slide 8 - Recommendations 35: Expanding the sources of 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:

  1. the safety of the proposed ingredient
  2. working with stakeholders to identify a broader range of appropriate sources of evidence
  3. 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.

Slide 9 - 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.

Slide 10 - 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.

Slide 11 - Recommendations 36 and 40: Use of comparable overseas 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:

  1. 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
  2. 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.

Slide 12 - Recommendation 36 and 40: Use of comparable overseas 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

  1. submission of a complete dossier for de novo assessment
  2. 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.

Slide 13 - 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 overseas assessment.

Slide 14 - Key features: Use of comparable overseas regulator reports

  • Criteria developed to confirm that there is sufficient similarity between a source of 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.

Slide 15 - 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.

Slide 16 - 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.

Slide 17 - 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.

Slide 18 - 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.

Slide 19 - 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.

Slide 20 - Stream 4: Increased predictability for industry

Stream 4: Increased predictability for industry
Recommendation Government Response
Recommendation 41: Develop additional legislative timeframes Accepts the recommendations
Recommendation 42: Management 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

Slide 21 - 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.

Slide 22 - 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
image outlining timeframes for all pre-market assessment

Slide 23 - 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.

Slide 24 - Recommendation 41: Ingredient timeframes

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. Application categories for complementary medicine ingredients:

Slide 25 - Recommendation 41: Ingredient timeframes

Proposed fees for assessment of new ingredients
Application category Application fee Evaluation Fee Total Fee

IN1

$1050

$14,000

$15,050

IN2

IN3

$2770

$22,900

$25,670

IN4

Slide 26 - Recommendation 41 – Example New Fee structure

Proposed fees for assessment of new ingredients
Application category Application fee Evaluation Fee Total Fee

IN1

$1050

$14,000

$15,050

IN2

IN3

$2770

$22,900

$25,670

IN4

Note: the same fees will apply for some application categories as use of reports from comparable overseas regulators are a new process that will not necessarily result in a reduction in work effort for the TGA. Reduced timeframes will apply.

Slide 27 - phased implementation for 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’

Slide 28 - 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.

Slide 29 - 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 on 26 September and will close 7 November.

Slide 30 - 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).

Slide 31 - Next steps

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

Slide 32 - Questions

Slide 33 - Find out more

Find out more via the web at www.tga.gov.au/mmdr Or emailing us at MMDR.consultation@health.gov.au

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