Ing. Helmut Schütz

EMEA-FDA GCP Initiative

EU – EMEA and U.S. FDA

The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities. This initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency and the US FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections (see press releases of 2009-08-03: EMEA^PDF, FDA^HTML).

Key objectives of the FDA-EMEA GCP initiative will be:

To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.

Details are given in EMEA/INS/GCP/541006/2008.

document date 2009-08-05 | last update 2010-08-04