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TGA webinar presentation: ARCS webinar, 14 March 2019

TGA Presentation: Consultation on reforms to the generic medicine market authorisation process

24 July 2019

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Presentation

  • Presented by: Dr Jeremy Shonberg
  • Presented at: ARCS webinar
  • Presentation date: 14 March 2019
  • Presentation summary: Presentation to ARCS Australia members on 14 March 2019 on the scope and content of the consultation

Transcript

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

Slide 1 - Outline

  • Why we are consulting
  • Scope and purpose of the reforms
  • Details of proposed reforms
  • Next steps

Slide 2 - 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 you input !

Slide 3 - Scope of the reforms

We are looking to create a more robust supply of generic medicines in Australia by:

  • Reducing barriers
  • Making the process clearer
  • Supporting international work sharing
  • Providing incentives in special cases

Future opportunities may exist for:

  • Similar reforms for other prescription and non-prescription medicines
  • Reforms to biosimilar medicines.

Slide 4 - 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
    • Pysical characteristics
    • Quantitative analysis 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

Slide 5 - 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

Slide 6 - 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

Slide 7 - 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, decision and registration
    • Fee structure
    • Data required
    • Administrative requirements

Slide 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 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.

Slide 9 - 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.

Slide 10 - How to make submissions

Consultation: Reforms to the 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

Slide 11 - 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

Slide 12 - Questions

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