FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Australia’s TGA Issues Guidance on Prescription Medicine Application Requirements

Feb. 26, 2018

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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