The first ARCS Regulatory Summit brought together speakers from the Therapeutic Goods Administration (TGA) to provide practical regulatory insights on a range of topics. The interactive, workshop-style event, which was held in Canberra, explored TGA collaboration and expedited regulatory pathways (including priority designations and provisional registration pathways), evaluation issues and common deficiencies, post approval change management (ICHQ12), labelling updates, and other anticipated reforms.
One of the key topics covered was priority designation, which provides faster assessment of vital and life-saving prescription medicines with a target timeframe of 150 working days (up to 3 months shorter than the standard registration pathway)[1].
The priority review follows a designation process where approximately 8-10 applications are granted priority designation per year. The TGA presenter emphasized that the decision to determine whether a medicine should be granted priority designation was based on the strength of evidence provided by the sponsor in addressing eligibility criteria. Demonstration of an improvement in efficacy and/or safety compared to registered medicines and the justification of major therapeutic advance were considered most significant. The presenter pointed out that priority designations were not granted or rejected based on TGA workload and reiterated that rejection of priority designation is simply that the medicine is not eligible for the shorter assessment timeframe. If priority designation is not granted, sponsors can still apply to register their medicine under the standard registration pathway.
A second topic covered was the provisional registration pathway[2]. This is a mechanism where medicines are registered on the basis of preliminary clinical data and where the benefit of early availability of the medicine outweighs potential risk. The availability of comprehensive non-clinical data on safety, quality and compliance with Good Manufacturing Practice is expected. Acceptance for evaluation via the provisional pathway involves a designation process where defined eligibility criteria need to be met including a clear timeline for the provision of additional clinical data for conversion to a full registration. While granting a provisional determination is a prerequisite of the provisional pathway, the TGA reminded the audience that provisional registration or approval of the medicine is not guaranteed.
Finally, the TGA brought attention to upcoming reforms to the prescription medicine process aimed at achieving greater consistency and improved decision predictability, as well as enhancing stakeholder experience and engagement. The reforms also seek to optimize resources and capabilities to improve access to medicines by reducing registration times. These reforms will be increasingly important as the volume of submissions increases and with it a continued backlog. With advances in automation and artificial intelligence in research and development expected to continue, TGA is looking to adapt its processes to these changes.
Although the reforms are still in the early phase, we will be closely monitoring developments and eagerly anticipating future progress.
How well do you understand the TGA’s regulatory pathways and evaluation processes? Are you struggling with any questions or issues involving a submission to the TGA? We would be interested in hearing about your experience. Contact us to learn more or for support with your TGA submission.
[1] Applying for a prescription medicine via the priority review pathway, TGA. https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-prescription-medicine/application-process-prescription-medicines/applying-prescription-medicine-priority-review-pathway
[2] Applying for a prescription medicine via the provisional registration pathway, TGA. https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-prescription-medicine/application-process-prescription-medicines/applying-prescription-medicine-provisional-registration-pathway
