News about GMP/cGMP

13.05.2022

EMA: Updating of Good Clinical Practice Annexes

EMA: Updating of Good Clinical Practice Annexes

The European Medicines Agency (EMA) has updated the annexes for the conduct of GCP inspections. First published in 2007, the annexes compile a number of seven documents.


Five of these annexes now correspond to the most recent status in accordance with the new requirements of the Clinical Trial Regulations (CRT). The CRT forms the foundation for inspectors when reviewing clinical trials and first came into force in the EU in January 2022.

The annexes updated are:


Source:
EMA: GCP inspection peocedures


 

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