Information on GCP inspections

12.07.2019

Since 1 January 2019 Swissmedic has required a completed EMA “GCP inspections template” for all application types whose documentation includes clinical trials (including bioequivalence trials).

As this new requirement has resulted in an increase in formal objections in the past, Swissmedic will soon be including the appropriate information regarding submission of the EMA template on the application submission forms.

Last modification 12.07.2019

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