Good clinical practice (GCP) inspection procedures

The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines Agency's (EMA) 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).

Guidance is available for inspectors on how to initiate and conduct remote inspections to verify compliance with GCP standards during the COVID-19 pandemic:

• Guidance on remote GCP inspections during the COVID-19 pandemic

The guidance covers all phases of remote GCP inspections, with a particular focus on the more challenging aspects, such as inspection initiation, feasibility assessment and preparation.

EMA published the guidance on 10 June 2020.

• Clinical study reports (E3)
• Good clinical practice (E6)