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 1 CMA Conference 26 October 2017
5 streams of work Stream 1 Enhancing the listing framework Stream 2 Increased flexibility for sponsors and improving the evidence base Stream 3 Improving transparency for consumers Increased predictability for industry Stream 4 Enhanced post-market monitoring and compliance actions Stream 5 2 CMA Conference 26 October 2017
Stream 1: Enhancing the listing framework Recommendation Government Response Recommendation 34: Capacity Supports the intent of the recommendation to refuse to list Recommendation 37: Online Accepts the recommendation searchable catalogue of permissible ingredients Recommendation 38 : Accepts the recommendation Establish a list of permitted indications 3 CMA Conference 26 October 2017
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 . 4 CMA Conference 26 October 2017
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. 5 CMA Conference 26 October 2017
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. 6 CMA Conference 26 October 2017
Stream 2: Increased flexibility for sponsors and improving the evidence base Recommendation Government Response Recommendations 35/36: Continue to evaluate Accepts both ingredients on safety, evidence and quality with two new recommendations methods for assessment of ingredients Recommendation 39: Three pathways for inclusion of Accepts the Listed medicines on the ARTG recommendation Recommendation 40: Develop two new pathways for Accepts the Registered complementary medicines recommendation 7 CMA Conference 26 October 2017
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: 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. 8 CMA Conference 26 October 2017
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. 9 CMA Conference 26 October 2017
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 . 10 CMA Conference 26 October 2017
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: 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. 11 CMA Conference 26 October 2017
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 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. 12 CMA Conference 26 October 2017
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. 13 CMA Conference 26 October 2017
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. 14 CMA Conference 26 October 2017
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. 15 CMA Conference 26 October 2017
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. 16 CMA Conference 26 October 2017
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. 17 CMA Conference 26 October 2017
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