AI
Wednesday, November 07, 2018 1:25:36 PM
Is data presented at CTAD suffiecient? If not, the TGA might come back with requirements for the P2b.
https://www.tga.gov.au/publication/provisional-determination
The P3 plan would have to be in place to apply -
the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years (starting on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine).
https://www.tga.gov.au/publication/provisional-determination-eligibility-criteria
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