Tuesday, 8 December 2009

EMEA and FDA strengthen collaboration on inspections

The FDA (US) and the EMEA (EU) have started a Bilateral GCP Initiative as of September 1st, 2009. This program has been enabled by confidentiality arrangements between the EU and the FDA which deals with GCP-related information contained in applications for scientific advice, orphan medicines designation, pediatric investigational plans and marketing authorisation or postauthorisation activities of significant public health interest.

The intention of this Joint Inspection Program is that it will help to protect clinical trial subjects in the growing globalisation of clinical research. Most of the time, the same trials are used for Marketing Authorisation Applications (MAA) both in the US and in the EU. This initiative intents to ensure that those trials are executed uniformly, appropriately and ethically.

It concerns a pilot phase of 18 months, after which a joint assessment will lead to modifications and amendments to the scope and process, as needed.

The key objectives are:
 - To conduct periodic information exchanges on GCP-related information
 - To conduct collaborative GCP inspections
 - To share information on interpretation of GCP

The two regulators are currently inviting companies who are planning to submit applications fairly simultaneously to both regulatory authorities between September 2009 and September 2010, to volunteer to partner in this pilot. wow gold

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