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ICH GCP renovation (ICH GCP E6(R3))

April 2021 Regulatory Affairs Watch

The E6(R3) working group is revising the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs and providing flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. Additional information may be found in ICH’s reflection paper on the GCP renovation on its Reflection Papers web page.

Source: ICH

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