The #GoodClinicalPractice (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 #initialreview of a #marketingauthorisation 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).

ANNEX III
TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: COMPUTER SYSTEMS