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. 1 Complementary Medicines: Regulatory Obligations Seminar
5 streams of work Stream 1 Enhancing the listing framework Stream 1 Stream 2 Improving transparency for consumers Stream 2 Increased flexibility for sponsors and improving the evidence base Stream 3 Stream 3 Increased predictability for pre-market approval Stream 4 Stream 4 Enhanced post-market monitoring and compliance actions Stream 5 2 Complementary Medicines: Regulatory Obligations Seminar
Stream 1: Enhancing the listing framework Recommendation Government Response Recommendation 34 Supports the intent of recommendation Capacity to refuse to list Recommendation 37 Accepts recommendation Online searchable catalogue of permissible ingredients Recommendation 38 Accepts recommendation Establish a list of permitted indications 3 Complementary Medicines: Regulatory Obligations Seminar
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 online 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 Supports the intent of the recommendation Requirement to publish efficacy evidence Supports the intent of the recommendation and will Recommendation 44 conduct further consultation on ways to better educate Publication of disclaimers on promotional material consumers however the Government will not require where product has not had efficacy assessed sponsors to place a disclaimer on product labels Recommendation 45 Publication of a ‘claimer’ where product has had Accept in principle efficacy assessed by TGA Recommendation 46 Accepts the recommendation Adopt or develop evidence monographs Complementary Medicines: Regulatory Obligations Seminar 7
Recommendation 46: Efficacy Monographs Recommendation 46 The Panel recommends that the NRA develops or adopts from comparable overseas 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 Accepts both recommendations with two methods for assessment of new ingredients Recommendation 39 Accepts the recommendation Three pathways for inclusion of listed medicines on the ARTG Recommendation 40 Accepts the recommendation Develop two pathways for registered complementary medicines 12 Complementary Medicines: Regulatory Obligations Seminar
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 overseas assessment (noting the difficulty of finding comparable overseas 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. 16
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 overseas assessment (noting the difficulty of finding comparable overseas regulators who could provide a total report on quality, safety and efficacy) C omplementary Medicines: Regulatory Obligations Seminar 17
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