FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Australia Wants to Improve Generic Drug Authorizations

Feb. 15, 2019
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Australia’s Therapeutic Goods Administration (TGA) is asking for feedback on changes it’s considering for its generic drug market authorization process — including the potential use of foreign reference products to show bioequivalence.

The agency wants to make the application process easier for drug sponsors and it may also reduce regulatory hurdles for generic prescription drug applicants.

The TGA’s plan proposes to reduce regulatory barriers through international collaboration, such as by work sharing with regulators overseas and using overseas reference products in bioequivalence studies. Currently, reference products in bioavailability studies must be approved in Australia.

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