FAQs on the EMA-FDA GCP Initiative published

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have agreed to launch a joint initiative to collaborate on international GCP inspection activities, which started with a 18-month pilot phase on 1 September 2009. This initiative comes under the scope of the confidentiality arrangements between the European Commission, the EMA and the FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes, and the conduct of collaborative inspections. This initiative is an important contribution to ensuring the protection of clinical-trial subjects in the context of the increasing globalisation of clinical research.

Now, a set of Questions and Answers has been published, where it is for example explained, why the two agencies have set up the initiative and what it will entail. The scope and potential benefits are also further outlined in this document, which can be found here: http://www.ema.europa.eu/Inspections/docs/gcp/Q&A_on_FDA_EMEA_GCP_Initiative.pdf.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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