EMA publishes Report on GCP Inspections

Recommendation

15/16 September 2020
Berlin, Germany

ICH Q12 - Product Life Cycle Management

The European Medicines Agency (EMA) has published a summary report about the findings in GCP inspections conducted worldwide between January 2000 and December 2012. This has been done in the course of the current transparency initiative.

The focus is on GCP inspections which have been performed within the scope of the centralised authorisation procedure at the request of the CHMP. The basis is an internal databsse of the EMA (Corporate DCP Database) which compiles all the significant findings.

Unfortunately, no information about each individual inspection can be derived. Nevertheless, the aim is to enable sponsors of clinical trials to take into account the information for a so-called "Risk based Quality Management" during the study planning and performance. The 50 page document contains very detailled statistical assessments - e.g. from the type and scope of the observed deficiencies, their category, up to the inspected party as well as further details about the inspections.