EMA updated Inspections procedure

On 7 October 2019, the 1,000th good clinical practice (GCP) inspection requested by EMA’s human medicines committee (CHMP) and coordinated by EMA was carried out.

The 1000th GCP Inspections requested by CHMP and coordinated by EMA was performed at a clinical investigators site in Toronto (Canada) by inspectors from Austria and Poland. EMA has developed an infographic showing the numbers and geographical locations of the CGP inspections requested by CHMP.

The GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections carried out 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.

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