The registration system for generic prescription medicines has not been amended since the introduction of the Streamlined Submission Process in 2010 and assigns all generics the same target timeframe of 255 working days. Amendments to the generic medicine registration process are under discussion that could provide for flexibility for certain applications and better support the timely availability of high quality generic medicines and the sustainability of the Australian health system.

1. Improving the regulation of generic medicines
in Australia
Facilitating timely availability of high quality and affordable
medicines to the Australian public
Dr Michael Ernst-Russell
Principal Evaluator
Pharmaceutical Chemistry Section
Scientific Evaluation Branch, Medicines Regulation Division, TGA
ARCS Annual Conference 2018
22 August 2018

2. Outline
• A summary of recent TGA prescription medicine reforms
• Options for generic medicine registration reforms
– pathway reform
– lifting the standard of generic medicine submissions
– other reform initiatives
• Next steps

3. Scientific Evaluation Branch
Pharmaceutical
Chemistry
Toxicology Biological
Science
Scientific
Operations
Management
Generic medicines
New chemical entities
Minor/major variations

4. Department of Health
Health Products Regulation Group
Medicines
Regulation
Scientific Evaluation
Complementary and Over
the Counter Medicines
Pharmacovigilance and
Special Access
Prescription Medicines
Authorisation
Medical Devices and
Product Quality
Medical Devices
Laboratories
Manufacturing Quality
Regulatory Practice
and Support
Regulatory Services and
Improvement
Regulatory Practice,
Education and
Compliance
Regulatory Engagement
and Planning

5. A recap of recent reform
The 2015 Medicines and Medical Devices Regulation Review recommended two
pathways to register a generic medicine on the ARTG:
• Pathway One - Submission of a complete dossier for de novo assessment
• Pathway Two - Submission of an un-redacted evaluation report from a
comparable overseas regulator, along with a copy of the dossier submitted to that
regulator (etc)

6. A recap of recent reform
The 2015 Medicines and Medical Devices Regulation Review recommended three
pathways to register a new chemical entity on the ARTG:
• Pathway One - Submission of a complete dossier for de novo assessment
• Pathway Two - Submission of an un-redacted evaluation report from a
comparable overseas regulator, along with a copy of the dossier submitted to that
regulator (etc)
• Pathway Three - Application for expedited approval of a medicine in certain
circumstances

7. Better regulation of generic medicines
• The key objective of the expedited pathways for new chemical
entities is to facilitate earlier access to medicines that address
unmet clinical needs for Australian consumers, without
compromising standards for safety, quality and efficacy
• An expedited pathway for generic medicines?
• What can a priority pathway for generic medicines facilitate?

8. Better regulation of generic medicines
An expedited pathway to assist in the prevention or alleviation of critical
medicine unavailability?
• Medicine supply disruptions occur for a range of reasons and can affect the availability of a
drug or dosage form in Australia
• The TGA currently makes use of informal and ad hoc processes to accelerate registration of
generic medicines in cases of unmet clinical need
• These processes are not currently transparent to consumer groups, health professionals or
sponsors
• The TGA could formalise a process to allow sponsors to request prioritisation for generic
medicine registration where this may help mitigate, resolve or prevent a drug shortage

9. Better regulation of generic medicines
An expedited pathway for significant new generic medicines?
• PBS listing of significant new generics leads to considerable cost savings for the Australian
health system
• Can the TGA contribute to these cost savings by formally prioritising the first registration of a
generic for some medicines?
• Would such prioritisation affect the timing of availability of significant new generic medicines
in Australia?

10. Prescription medicine application approval time for
2016-17 financial year
https://www.tga.gov.au/annual-performance-statistics-report-july-2016-june-2017

11. Lifting the quality of generic submissions
• Currently all generic medicine applications involve requesting further information from
sponsors
• TGA is often faced with outstanding issues at the conclusion of the evaluation phase

12. Lifting the quality of generic submissions
• Incentives for good quality dossiers – a more rapid decision?
• Disincentives for poor quality dossiers – a mandatory stop clock?

13. Other reform initiatives
Improvements under consideration or in process
• Pre-consideration of some justifications relating to biopharmaceutic data
• Implementation of harmonised bioavailability/bioequivalence submission
templates (replacing Mod 1.11)
• Review of submission mandatory requirements

14. Other reform initiatives
Initiatives under consideration or in process
• Definition of a generic medicine, a ‘hybrid’ generic medicine?
• An instructive web-based provisional ARTG ‘user’s guide’ for sponsors
• Enhanced web-based guidance for holders of Drug Master Files

15. Next steps
• The reform program is in initial stages
• TGA has had informal preliminary discussions to
guide our considerations
• Broader consultations will follow

16. Questions