BEBAC  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: EMEAPDF, Internet Archive FDAHTML).

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

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

See also the December 2013 Joint initiative to share information on inspections of bio­equivalence studies.