Australia Considers Changes To Bioequivalence Requirements For Foreign Comparators

07 Feb 2019
News

Vibha Sharma @ScripRegVibha vibha.sharma@informa.com

Executive Summary

Changing Australian requirements on showing equivalence with an overseas reference product used in bioequivalence studies, and introducing a new early scientific advice service for biowaiver proposals, are among key proposals made by the Therapeutic Goods Administration as part of reforms in the generic medicines sector.

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Australia Considers Changes To Bioequivalence Requirements For Foreign Comparators

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