The European Medicines Agency (EMA) has updated the Annexes for the conduct of GCP inspections. The documents first published in 2007 were prepared by Good Clinical Practice (GCP) Inspectors Working Group for the coordination, preparation, conduct and reporting of GCP inspections requested by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in the context of the centralised procedure. These inspections are adopted by the CHMP and may be routine or may be triggered by issues arising during the assessment of the dossier or by other information such as previous inspection experience. They are usually requested during the initial review of a marketing authorisation application, but could arise post-authorisation (e.g., inspection of studies conducted or completed as part of the condition of a marketing authorisation, or because of concerns arising about the studies previously submitted).

Five out of seven of these Annexes now correspond to the most recent status in accordance with the new requirements of the Clinical Trial Regulations No 536/2014 (CRT). The CRT forms the foundation for inspectors when reviewing clinical trials and first came into force in the European Union (EU) in January 2022.

The annexes updated are:

• ANNEX I to procedure for conducting GCP inspections requested by the CHMP: Investigator site
• ANNEX II to procedure for conducting GCP inspections requested by the CHMP: Clinical laboratories
• ANNEX IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO)
• ANNEX VI to procedure for conducting GCP inspections requested by the CHMP: Record keeping and archiving of documents
• ANNEX VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials