Reforms to the Regulation of Complementary Medicines Lyndall Soper - - PowerPoint PPT Presentation

Reforms to the Regulation of Complementary Medicines

Lyndall Soper Assistant Secretary, Complementary and OTC Medicines Branch Medicines Regulation Division, TGA

Complementary Medicines: Regulatory Obligations Seminar

11 April 2017

Review of Medicines and Medical Devices Regulation

July 2015 - MMDR review was released by Expert Panel

• 19 recommendations to improve the regulation of

complementary medicines 15 September 2016 - Government response released

• accepted the majority of the review’s

recommendations in full or in-principle

• identified the need for consultation with stakeholders

in progressing the reforms.

Complementary Medicines: Regulatory Obligations Seminar 1

5 streams of work

Stream 1

Enhancing the listing framework

Stream 1

Improving transparency for consumers

Stream 2

Increased flexibility for sponsors and improving the evidence base

Stream 3

Increased predictability for pre-market approval

Stream 4

Enhanced post-market monitoring and compliance actions

Stream 5 Stream 2 Stream 3 Stream 4

Complementary Medicines: Regulatory Obligations Seminar 2

Stream 1: Enhancing the listing framework

Recommendation Government Response

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

Complementary Medicines: Regulatory Obligations Seminar 3

Recommendation 37: Catalogue of Permissible Ingredients

Recommendation 37 The Panel recommends that the TGA develop and maintain a real time, readily accessible catalogue of approved ingredients for use in listed medicinal products. Government response The Commonwealth accepts Recommendation Thirty-Seven, as it will provide a single readily accessible list of ingredients for sponsors and the general public, minimising unnecessary regulatory burden.

Complementary Medicines: Regulatory Obligations Seminar 4

Recommendation 37 – Key Features

• All listed medicine ingredient information and

associated restrictions now available in a single

• nline database

(before they were in 6 volumes of PDFs on FRLI)

• Updates to the online database will be made to

match updates to the Permissible Ingredients Determination

• Ability to conduct searches using ingredient

information such as; synonym terms, key words

Complementary Medicines: Regulatory Obligations Seminar 5

Recommendation 37: Key Features

• Enhancement of Ingredient Table search results to make it more obvious where

to find detailed ingredient information:

• Hyperlinks
• Less clicking for users
• Improved access to the Ingredients Table:
• Direct link from the TGA homepage to Ingredient Table search

Complementary Medicines: Regulatory Obligations Seminar 6

Stream 2: Improving transparency

Recommendation Government Response

Recommendation 43 Requirement to publish efficacy evidence Supports the intent of the recommendation Recommendation 44 Publication of disclaimers on promotional material where product has not had efficacy assessed Supports the intent of the recommendation and will conduct further consultation on ways to better educate consumers however the Government will not require sponsors to place a disclaimer on product labels Recommendation 45 Publication of a ‘claimer’ where product has had efficacy assessed by TGA Accept in principle Recommendation 46 Adopt or develop evidence monographs Accepts the recommendation

Complementary Medicines: Regulatory Obligations Seminar 7

Recommendation 46: Efficacy Monographs

Recommendation 46 The Panel recommends that the NRA develops or adopts from comparable

• verseas regulators, efficacy monographs for commonly used active

ingredients that have been approved for use in listed medicinal products. Government response The Commonwealth accepts Recommendation Forty-Six, as the development or adoption from comparable regulators of monographs has the potential to improve the availability and accuracy of information for consumers and to reduce time and costs for industry.

Complementary Medicines: Regulatory Obligations Seminar 8

Who Will use Monographs?

TGA efficacy monographs for complementary medicines may be used by:

• SPONSORS of low risk medicines as a primary source of evidence to support

permitted indications. – If fully compliant with a monograph, a sponsor will not be required to hold an evidence package for their medicine.

• CONSUMERS as a reliable and trusted source of information to inform their

medicine choices.

• OTHER REGULATORS as a reliable and trusted source of information.

Complementary Medicines: Regulatory Obligations Seminar 9

Monographs – Next Steps

Monographs could be developed in a number of ways:

• Adoption of monographs of comparable regulators in full
• Adoption of monographs with a TGA annotation
• Developing our own TGA monographs

Candidate ingredients for monograph development could be based on e.g., top ingredients included in the ARTG, top selling products. Further targeted consultation with industry is planned to help refine priorities for adopting or developing monographs and the approach to their development

Complementary Medicines: Regulatory Obligations Seminar 10

Monographs

Benefits for Industry

• Sponsors that complied with ingredient based monographs would not

be required to hold an evidence package

• Considerable savings for small to medium sized sponsors
• Provide a level of assurance to all sponsors that the evidence for

indications on their product are sound

Complementary Medicines: Regulatory Obligations Seminar 11

Stream 3: Increased Flexibility for Sponsors and improving the evidence base

Recommendation

Government Response

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

Complementary Medicines: Regulatory Obligations Seminar 12

Recommendations 35 & 36: Assessment of new ingredients

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.

Complementary Medicines: Regulatory Obligations Seminar 13

Recommendations 35 & 36: Assessment of new ingredients

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. 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.

Complementary Medicines: Regulatory Obligations Seminar 14

Methods for assessment of new ingredients

Current situation

• Only accept data for de novo assessment

Changes proposed under Recommendations 35 & 36

• 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 (noting the difficulty of finding comparable
• verseas regulators who could provide a total report)
• Explore options for expanding the range of acceptable evidence

(monographs from suitable regulators, WHO, EFSA etc)

Complementary Medicines: Regulatory Obligations Seminar 15

Recommendations 40: Comparable overseas regulators for Registered Complementary Medicines

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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Methods for assessment of Registered Comp Meds

Current situation

• Only accept data for de novo assessment of RCMs

Changes proposed under Recommendations 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

(noting the difficulty of finding comparable overseas regulators who could provide a total report on quality, safety and efficacy)

C

• mplementary Medicines: Regulatory Obligations Seminar

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Stream 4: Increased predictability for pre-market approval

Recommendation Government Response

Recommendation 41 Develop legislative timeframes for premarket assessment Accepts the recommendation 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

Complementary Medicines: Regulatory Obligations Seminar 18

Recommendation 41 – Legislative timeframes

Panel 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

Com plementary Medicines: Regulatory Obligations Seminar 19

Recommendation 41 – Legislative timeframes

Government response The Commonwealth accepts Recommendation Forty- One, noting that development of legislative timeframes will be subject to further consultation with stakeholders. How will we will do this?

• Development of risk based application categories

for pre-market assessed complementary medicines

• Implementation of associated timeframes and fees

Complementary Medicines: Regulatory Obligations Seminar 20

Recommendation 47 – Review and Appeal Rights

Panel Recommendation: In revising the Therapeutic Goods Act 1989 and subordinate legislation, the Australian Government provides review and appeal rights for the sponsor who has lodged an application for a new ingredient (to be approved for a listed medicine) to seek a review of an NRA decision regarding that application. Government response: The Commonwealth supports the intent of Recommendation Forty-Seven. The design of potential review and appeal rights requires careful consideration of the application of administrative law principles in this context.

Com plementary Medicines: Regulatory Obligations Seminar 21

Recommendation 47 – Review and Appeal Rights

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Process

Application for new ingredient Evaluation Initial decision Approved Included in permitted ingredient list Refused Appeal made by applicant to Minister Internal review Administrative Appeals Tribunal

Amendments to the Therapeutic Goods Act to implement review and appeal rights are currently before Parliament.

Stream 5: Enhanced post-market monitoring and compliance actions

Recommendation Government Response

Recommendation 49: Post market monitoring scheme Accepts the recommendation; noting that the intent of some elements of the recommendation can be achieved within existing mechanisms

Complementary Medicines: Regulatory Obligations Seminar 23

Recommendation 49 – Enhanced Post Market Monitoring

Panel Recommendation: A more comprehensive post-market monitoring scheme for listed medicinal products, including complementary medicinal products. Such a scheme should include:

• an increase in the number of products subject to random/targeted reviews
• integration of available datasets, including eHealth and hospital records, to

provide a more streamlined and cost effective approach to post-market monitoring

• provision for electronic reporting of adverse events; and
• enhanced collaboration with overseas NRAs to share information relating to

safety or efficacy of comparable products.

Complementary Medicines: Regulatory Obligations Seminar 24

Recommendation 49 – Enhanced Post Market Monitoring

Government response: The Commonwealth accepts Recommendation Forty-Nine, as the development of a more comprehensive post-market monitoring scheme will enhance consumer protection and complement existing post-market monitoring processes. How are we going to do this?

• Increase the number of compliance reviews completed each year
• Using information from available datasets to better target areas of known non-

compliance

Complementary Medicines: Regulatory Obligations Seminar – 11 April 2017 25

Indicative timeframes of all the Recommendations

Phased implementation in the next 12 to 24 months By 12 months

• An online catalogue of ingredients approved for use in listed medicines
• Permitted indications
• New assessment pathways for registered complementary medicines and new ingredients
• Risk-based approach to medicine variations

By 24 months

• New listing pathway
• Label claimer

Complementary Medicines: Regulatory Obligations Seminar 26

Legislation Process

• Delivery of many reforms is dependent on passage of legislative amendments

and regulatory changes

• First set of legislative amendments (Bill 1) introduced to Parliament in late 2016

– changes to come into effect in June 2017 – some focus on creating regulatory-making powers

• Second set of amendments (Bill 2) focus on reforms to come into effect in 2018

Complementary Medicines: Regulatory Obligations Seminar 27

Legislation Process

• Need for legislation identified

– Consultation – Regulation Impact Statement – Policy approval

• Preparation of a ‘Bill’

– Drafting instructions – Ministerial Clearance – Preparation of supporting materials

• Legislation approval process

Draft Bill House of Representatives Bill presented First reading Second reading (in principle debate) Consideration in details (amendments may be made) Third reading Senate Similar process to the House of Representatives Governor-General Assent

Complementary Medicines: Regulatory Obligations Seminar 28

MMDR consultations

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

and 50 are addressed in our first public consultation paper.

• Other MMDR recommendations relating to complementary

medicines will be the subject of consultation in late 2017.

• See the MMDR public consultation forecast on the TGA website

for further information.

Complementary Medicines: Regulatory Obligations Seminar 29

First consultation: Complementary medicine assessment pathways

• A list of permitted indications for lowest risk medicines

Recommendation 38

• Introduce a new middle pathway to make a three-tiered risk-

based framework Recommendation 39

• Allow sponsors to claim their medicine has been assessed for efficacy

Recommendation 45

• Incentivise industry innovation

Recommendation 50

Complementary Medicines: Regulatory Obligations Seminar 30

Consultation Submissions

A total of 58 submissions were received in response to public consultation, which comprised:

• 20 submissions from industry
• 4 submissions from peak industry bodies
• 13 submissions from healthcare professional bodies
• 3 submissions from academic institutions
• 4 submissions from consumer and other professional bodies
• 6 submissions from practitioners
• 6 submissions from individuals
• 2 submissions from government agencies

Complementary Medicines: Regulatory Obligations Seminar 31

Consultation Responses

The outcomes of analysis of the submissions from the public consultation show that:

• The majority support the introduction of a new pathway
• A large majority supported the criteria proposed for indications and the claimer
• A large majority support innovation for the complementary medicines sector

whether this is via market exclusivity for new ingredients or data protection for efficacy data on the finished product formulation

Complementary Medicines: Regulatory Obligations Seminar 32

Next steps

• Legislative amendments to the Therapeutic Goods Act 1989 and the

Therapeutic Goods Regulations 1990

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

Complementary Medicines: Regulatory Obligations Seminar 33

Questions?

Complementary Medicines: Regulatory Obligations Seminar 34

Find out more:

www.tga.gov.au/mmdr

MMDR.consultation@health.gov.au