FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Australia’s TGA Issues Guidance on Prescription Medicine Application Requirements

Feb. 26, 2018
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Australia’s Therapeutic Goods Administration updated guidance detailing information the agency requires for prescription medicine applications to be considered eligible for evaluation, adding requirements for the comparable overseas regulator (COR) report-based process.

The guidance, which applies to applications filed with the TGA from Feb. 9, states that COR report-based applications must use a pre-submission planning form option available for the standard prescription medicine registration process.

The agency also removed a requirement that two independent evaluation reports be provided at the time of application from acceptable countries where the product is already approved.

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