The TGA is consulting on reforms to streamline the generic medicine market authorisation process. The proposed reforms include: 1) Reducing regulatory barriers such as relaxing requirements for dissolution data and reference products in bioequivalence studies. 2) Providing more certainty on data requirements through early advice on biowaiver justifications. 3) Supporting international work sharing by using common templates for bioequivalence studies and biowaiver justifications. 4) Prioritizing applications for generic medicines that address shortages or high expenditure to encourage more competition. Feedback is sought through an online consultation closing March 21. The reforms aim to enhance supply of affordable generic medicines in Australia.

1. 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

2. Outline
Why we are
consulting
Scope and
purpose of the
reforms
Details of
proposed
reforms
Next steps
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3. 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!
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4. Scope of the reforms
• 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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5. 1. Reducing regulatory barriers
Product labels Dissolution data Physical
characteristics
Quantitative analysis
of components
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 4

6. 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
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7. 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
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8. 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 & registration
Fee structure Data required Administrative
requirements
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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 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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10. 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.
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11. How to make submissions
• https://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

12. 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
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13. Questions
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