FDA, European agencies extend confidentiality arrangements

December 6, 2005

Washington--The Food and Drug Administration (FDA), the European Commission (EU) and the European Medicines Agency (EMA) have agreed to a five-year extension of their confidentiality arrangements regarding medicines for human and veterinary use.

Washington-The Food and Drug Administration (FDA), the European Commission (EU) and the European Medicines Agency (EMA) have agreed to a five-year extension of their confidentiality arrangements regarding medicines for human and veterinary use.

The confidentiality arrangements, originally signed in September 2003, allow the FDA, the EC and the EMEA to exchange information as part of their regulatory processes. The arrangements cover information such as legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing-authorization procedures and post-marketing surveillance.

The arrangements cover medicinal products that are subject to evaluation and those that are authorized at national levels by EU member states and subject to European Community arbitrations and referrals.