The Therapeutic Good Administration (TGA) has released draft guidance documentation for the Provisional Approval pathway for prescription medicines that is currently being developed in response to recommendations of the Medicines and Medical Devices Regulation Review.
The TGA advises that implementation is planned for January 2018, subject to the passage of amendments to the Therapeutic Goods Act and Regulations, which are currently before the lower house.
Eligibility for the Provisional Approval pathway will be determined through a formal designation process. The sponsor must demonstrate the seriousness of the condition, comparison against existing registered therapeutic goods and promising evidence of a major therapeutic advance.
This consultation follows on from the initial public consultation papers on the Expedited pathways for prescription medicines: Eligibility Criteria and designation process, which was released in late 2016, the subsequent public consultation on the Provisional Approval pathway, which was conducted earlier this year and the Exposure Draft of the legislation which was discussed with stakeholders prior to introduction into parliament.
The TGA is seeking feedback on major issues relating to the content of the guidance, given the level of consultation completed to date, as considering the limited timeframe to make guidance available prior to the planned implementation date. Responses are sought on whether the draft guidance usable including being sufficiently clear and easy to follow, important aspects that are not currently covered and any major issues relating to the content of the guidance that are likely to affect industry.
Presently, there is no formal mechanism for registering prescription medicines on the basis of early clinical data, which is out of step with comparable overseas regulators.
The new pathway will provide a formal and transparent process for the registration of certain promising medicines on the basis of early clinical data. It is envisaged that medicines may reach patients with unmet needs up to two years earlier than under the current framework.
The draft documents are available by contacting AusBiotech (Lorraine Chiroiu lchiroiu@ausbiotech.org) or from the TGA (policyandreformfacilitation@health.gov.au). Written submissions are due by close of business on Friday 17 November 2017.
Implementation arrangements will be in place during the months leading up to the expected Provisional Approval pathway implementation date of January 2018 until around 18 months following this date.