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FDA and EMA Extend Confidentiality Agreement “Indefinitely”

Sep 17th, 2010

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FDA and the European Medicines Agency (EMA) are extending their confidentiality agreement covering information-sharing on human and veterinary medicine products “indefinitely without the need for further renewal” due to positive experiences by both agencies during the seven years the agreement has been in place.

The agreement allows the agencies to exchange confidential information in the areas of:  ● scientific advice, ● orphan drug designation ● pediatric development ● GMP and GCP inspection planning and reports ● marketing authorization procedures ● changes to marketing authorizations, and ● post-market surveillance.

The confidentiality arrangements cover all human and veterinary medicines approved by FDA.  In the EU, it covers those products that are evaluated or authorized under the centralized procedure as well as medicines that are authorized at the national level by the EU Member States and that are subject to official European Community arbitrations and referrals.

[More on the FDA/EU and other international confidentiality agreements is provided for subscribers on page 2.]

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