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Background and progress of complementary medicine reforms
This document provides an overview and update on the progress of reforms to the regulation of complementary medicines in Australia. It discusses five streams of work being undertaken to enhance the listing framework, improve evidence requirements, increase transparency, predictability for industry, and post-market monitoring. Key elements that have been or will be implemented include permitted indications for listed medicines, market exclusivity for new ingredients, and a new assessed listed medicines pathway. The document outlines consultations held on proposals and next steps, which involve further legislative amendments, consultation, education and updated guidelines.
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Background and progress of complementary medicine reforms
- 1. Complementary medicines reforms sponsoreducation workshops Background and progress Michael Shum Director, Complementary and OTC Medicines Branch Medicines Regulation Division, TGA
- 2. Welcome introduction Michael Shum– Director, Complementary Medicines Reforms, Complementary and OTC Medicines Branch Dr Michael Gardner – Director, Complementary Medicines Evaluation Section, Complementary and OTC Medicines Branch 2017 Sponsor Education Workshops 1
- 3. Agenda • Overview andupdate of the progress of complementary medicine reforms – 30 minutes • Permitted indications – 75 minutes • Legislative overview • Transition arrangements • Applying for new indications • Break – 15 minutes • Assessed listed medicines pathway & Evidence guidelines – 60 minutes 2017 Sponsor Education Workshops 2
- 4. Review of Medicinesand Medical Devices Regulation • In March 2015 the Expert Panel conducting the Medicine and Medical Devices Review (MMDR) 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 majority of the reforms outlined in the Response will be implemented between 2018-2019. 2017 Sponsor Education Workshops 3
- 5. Five streams ofwork Enhancing the listing frameworkStream 1 Increased flexibility for sponsors and improving the evidence baseStream 2 Improving transparency for consumersStream 3 Increased predictability for industryStream 4 Enhanced post-market monitoring and compliance actions Stream 1 Stream 2 Stream 3 Stream 4 Stream 5 2017 Sponsor Education Workshops 4
- 6. Principles guiding complementarymedicine reforms • Maintain confidence in TGA regulation of complementary medicines • The level of regulation of medicines is commensurate with risk • Transparency on the level of assessment undertaken by the TGA and avoid consumers being misled by medicine indications • Improve sponsor compliance with regulatory requirements • Clear guidance on application processes and requirements • Support innovation and increase the evidence base and the standard of evidence for complementary medicines • Enable higher level indications to be made for listed medicines where that medicine’s evidence has been evaluated by the TGA 2017 Sponsor Education Workshops 5
- 7. Implemented reforms • InMarch 2017, the online catalogue of ingredients approved for use in listed medicines was implemented. • From 1 July 2017, sponsors who lodge applications for evaluation of new ingredients for use in complementary medicines are able to apply for review and appeal of decisions relating to those assessments. 2017 Sponsor Education Workshops 6
- 8. Staged implementation –indicative timeframes By 2018 – Permitted Indications – Market exclusivity for newly approved ingredients for applications submitted from January 2018 – Risk-based approach to medicine variations By 2019 – Assessed listed medicines pathway launched – Label ‘claimer’ 72017 Sponsor Education Workshops
- 9. Consultations • Targeted stakeholderconsultations commenced October 2016 • Public consultations throughout 2017 • Consultation outcome available at MMDR public consultation forecast on the TGA website • More consultation to come in 2018 2017 Sponsor Education Workshops 8
- 10. First consultation oncomplementary medicines • A list of permitted indications for lowest risk medicines Recommendation 38 • Introduce 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 2017 Sponsor Education Workshops 9
- 11. Consultation outcomes • Introducepermitted indications to limit the indications that can be made for listed medicines • Providing a 2 year period of protection for new ingredients approved for use in listed medicines • Introduction of a new pathway for assessed listed medicines will sitting between the existing listed and registered pathways • Further consultation required to finalise the label ‘claimer’ 2017 Sponsor Education Workshops 10
- 12. Overview of complementarymedicines reforms Premarket evaluation for: • Quality • Safety • Efficacy • Can use ‘claimer’ (Rec 45) Registered medicines AUST R Premarket evaluation for: • Efficacy – Intermediate level indications • Can use a ‘claimer’ (Rec 45) BUT • GMP • Pre-approved ingredients Assessed Listed medicines AUST L(A) No premarket evaluation BUT: • GMP • Pre-approved ingredients • Permitted indications Listed medicines AUST L Australian Register of Therapeutic Goods (ARTG) Higher riskLower risk 2017 Sponsor Education Workshops 11
- 13. Second consultation oncomplementary medicines • Expanding the sources of evidence for ingredient assessments Recommendation 35 • Use of reports from comparable overseas regulators Recommendation 36 and 40 • Legislative timeframes for pre-market assessments Recommendation 41 • Enhanced post-market compliance scheme Recommendation 49 2017 Sponsor Education Workshops 12
- 14. Key features: Acceptablesources 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 • The source of evidence must be in English, peer reviewed and consistent with the current body of knowledge. Any conflicts must be identified. • The way in which the submitted evidence source is developed must be consistent with internationally recognised guidelines and standards 2017 Sponsor Education Workshops 13
- 15. Recommendation 36 and40 - 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 2017 Sponsor Education Workshops 14
- 16. Recommendation 41: KeyFeatures • 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 Pre-submission meeting Submission Screening Evaluation Decision Implementation 2017 Sponsor Education Workshops 15
- 17. Recommendation 41: KeyFeatures • 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 2017 Sponsor Education Workshops 16
- 18. Consultation outcomes • TheConsultation on Business Process Improvements supporting Complementary Medicines Assessment Pathways closed on 7 November 2017 • 14 submissions received • Submissions will be analysed and outcomes reported back to the Minister • TGA’s response to the consultation submissions will be published on the TGA website in the coming months • Responses indicate a general support for the proposed timeframes and application categories – some concern surrounding the fees and criteria for use of overseas reports – clarity sought on the legislated timeframes and submission process 2017 Sponsor Education Workshops 17
- 19. Next steps • Legislativeamendments to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 • Further consultation • Sponsor education • Updated guidelines 2017 Sponsor Education Workshops 18
- 20. Questions 2017 Sponsor EducationWorkshops 19
Editor's Notes
- #3 The Expert Panel was asked to examine the TGA’s regulatory framework and processes in respect of prescription, over‐the‐counter, and complementary medicines and medical devices with a view to identifying: Areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and Opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
- #4 The Expert Panel was asked to examine the TGA’s regulatory framework and processes in respect of prescription, over‐the‐counter, and complementary medicines and medical devices with a view to identifying: Areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and Opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
- #5 The Expert Panel was asked to examine the TGA’s regulatory framework and processes in respect of prescription, over‐the‐counter, and complementary medicines and medical devices with a view to identifying: Areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and Opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
- #17 A standard application and evaluation process for all pre-market assessment Partial refund of evaluation fee if timeframes are not met