Consultation on reforms to the generic medicine market authorisation - - PowerPoint PPT Presentation
Consultation on reforms to the generic medicine market authorisation process Dr Jeremy Shonberg Assistant Director Scientific Operations Management Scientific Evaluation Branch ARCS Webinar 14 March 2019 Outline Scope and Details of
Dr Jeremy Shonberg Assistant Director Scientific Operations Management Scientific Evaluation Branch ARCS Webinar – 14 March 2019
Consultation on reforms to the generic medicine market authorisation process 1
Enhance the TGA’s regulatory framework Better support the supply of generic medicines Improve the market authorisation process Encourage applications for certain generic medicines
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– We are looking to create a more robust supply of generic medicines in Australia by: Future opportunities may exist for: Similar reforms for other prescription and non-prescription medicines Reforms to biosimilar medicines. Reducing barriers Making the process clearer Supporting international work sharing Providing incentives in special cases
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– – – Product labels Dissolution data Physical characteristics Quantitative analysis
Use of overseas reference product in bioequivalence (BE) studies The overseas reference product must be identical to the Australian reference product Evidence required includes: We have begun preliminary investigation into: § § what evidence should be provided to demonstrate identicality of reference products approaches taken by comparable overseas regulatory agencies
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– – – Early advice on biowaiver justifications We are considering introducing means to allow applicants to seek formal scientific advice from the TGA on a proposed justification for a biowaiver. Aspects to be considered: Explicit and limited number of technical issues specific to biowaiver justifications No additional regulatory burden Possible future broader use
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International templates – § § – § § Internationally-used templates will: allow same information in the same format to multiple countries provide a checklist for applicants We have identified the following international templates: Bioequivalence trial information Biowaiver justification templates
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We conducted a preliminary investigation of how a similar process may be applicable in the Australian context We are considering possible incentives to encourage applications for generic medicines of special interest Time for evaluation, decision & registration Fee structure Data required Administrative requirements
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§ § § We have identified two particular cases where a more robust supply of generic medicines may be beneficial to patients and the Australian health system: Case study 1. Medicine shortages We recently introduced mandatory reporting of medicine shortages We are investigating: Proactive approaches to diversify supply How to encourage more generic versions of medicines, e.g. those on TGA Medicines Watch List.
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§ § § We have identified two particular cases where a more robust supply of generic medicines may be beneficial to patients and the Australian health system: Case study 2. Medicine expenditure The cost of medicines is a significant burden for the Australian health system. To address medicine expenditure we are investigating a priority system where applications are evaluated more quickly go to the head of the evaluation queue.
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www.tga.gov.au/consultation/consultation-reforms-generic-medicine-market-authorisation-process
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This consultation closes on 21 March 2019 Any questions relating to submissions should be directed to: generic.medicines.reform@tga.gov.au
will be a program of coordinated projects. Review submissions Use feedback to shape project plans Conduct further targeted consultation on more specific details of individual projects Determine implementation timeframes for each project based on complexity and feedback received
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