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 Why we are purpose of the proposed Next steps consulting reforms reforms Consultation on reforms to the generic medicine market authorisation process 1

Why are we consulting? We are exploring opportunities to: • Enhance the TGA’s regulatory framework • Better support the supply of generic medicines • Improve the market authorisation process • Encourage applications for certain generic medicines We need your input! Consultation on reforms to the generic medicine market authorisation process 2

Scope of the reforms • We are looking to create a more robust supply of generic medicines in Australia by: Reducing barriers Making the process Supporting international Providing incentives clearer work sharing in special cases • Future opportunities may exist for: – Similar reforms for other prescription and non-prescription medicines – Reforms to biosimilar medicines. Consultation on reforms to the generic medicine market authorisation process 3

1. Reducing regulatory barriers Use of overseas reference product in bioequivalence (BE) studies – The overseas reference product must be identical to the Australian reference product – Evidence required includes: Product labels Dissolution data Physical Quantitative analysis characteristics of components – We have begun preliminary investigation into: § what evidence should be provided to demonstrate identicality of reference products § approaches taken by comparable overseas regulatory agencies 4

2. Better certainty on data requirements 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 Consultation on reforms to the generic medicine market authorisation process 5

3. Supporting work sharing opportunities 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 Consultation on reforms to the generic medicine market authorisation process 6

4. Generic medicines of special interest • In recent years the US-FDA has introduced a priority review process for generic medicines • 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, Fee structure Data required Administrative decision & registration requirements Consultation on reforms to the generic medicine market authorisation process 7

4. Generic medicines of special interest • 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. Consultation on reforms to the generic medicine market authorisation process 8

4. Generic medicines of special interest • 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. Consultation on reforms to the generic medicine market authorisation process 9

How to make submissions • https:// www.tga.gov.au/consultation/consultation-reforms-generic-medicine-market-authorisation-process This consultation closes on 21 March 2019 Any questions relating to submissions should be directed to: generic.medicines.reform@tga.gov.au Consultation on reforms to the generic medicine market authorisation process 10

Next steps Reforms to the generic medicine market authorisation process 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 Consultation on reforms to the generic medicine market authorisation process 11

Questions Consultation on reforms to the generic medicine market authorisation process 12