Sunday, April 14, 2019 5:49:36 PM
The timeline and requirements for provisional approval in Australia:
In summary
1. Determination process - 3-6 months pre-dossier; 2. Pre-market registration process - Maximum 255 working days; 3. Provisional registration period - 2 year initial period; 4. Extension of provisional registration - 2 possible extensions (each up to 2 years); 5. Transition to full registration - Maximum 255 working days.
The provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG). It provides access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.
Provisional registration of prescription medicines under this pathway is limited to a maximum of six years. Registration will automatically lapse at the end of a specified period unless sponsors are able to demonstrate that they have met the conditions imposed on the provisional registration. Sponsors may apply for full registration when sufficient clinical data to confirm the safety and efficacy of the medicine are available.
The Provisional approval pathway consists of five steps as outlined in the Provisional approval diagram [see right]: provisional determination, pre-market registration, the provisional registration period, extension of provisional registration and transition to full registration.
Date March 20, 2018. Missling announces the P2/3 on July 3. What are the odds that this is what he was waiting for?
https://www.tga.gov.au/provisional-approval-implementation-arrangements
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