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
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 1
Scientific Evaluation Branch Biological Pharmaceutical Toxicology Scientific Science Chemistry Operations Management Generic medicines New chemical entities Minor/major variations
Department of Health Health Products Regulation Group Medicines Medical Devices and Regulatory Practice Regulation and Support Product Quality Scientific Evaluation Regulatory Services and Medical Devices Improvement Complementary and Over Laboratories the Counter Medicines Regulatory Practice, Education and Pharmacovigilance and Compliance Special Access Manufacturing Quality Regulatory Engagement Prescription Medicines and Planning Authorisation 3
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) 4
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 5
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?
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 7
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? 8
Prescription medicine application approval time for 2016-17 financial year https://www.tga.gov.au/annual-performance-statistics-report-july-2016-june-2017
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 10
Lifting the quality of generic submissions • Incentives for good quality dossiers – a more rapid decision? • Disincentives for poor quality dossiers – a mandatory stop clock? 11
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 12
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 13
Next steps • The reform program is in initial stages • TGA has had informal preliminary discussions to guide our considerations • Broader consultations will follow 14
Questions 15
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