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Regulatory Recap: Generic Medicines Work-Sharing Initiative Outlines Foreign Comparator Acceptability

FDA and EMA’s New Guidances, Swissmedic Approval Timelines, And Biosimilars In Singapore

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews the latest regulatory events across the world.

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• Source: Shutterstock

The Generic Medicines Work-Sharing Initiative, led by five regulatory agencies that are members of the Access Consortium, has provided more detail on the acceptance of foreign comparators in bioequivalence studies in each participating country.

The Access Consortium is a coalition of “like-minded” regulatory authorities, aiming to promote regulatory alignment and collaboration.

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