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:
- ANNEX I – TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS: Investigator site
- ANNEX II – TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS: Clinical laboratories
- ANNEX IV – TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS: Sponsor and Contract Research Organisations (CRO)
- ANNEX VI – TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS: Record keeping and archiving of documents
- ANNEX VII – TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials
Source:
EMA: GCP inspection peocedures
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