EU, FDA extend confidentiality arrangements

The European Commission, the European Medicines Agency and the U.S. Food and Drug Administration have extended their confidentiality arrangements related to medicinal products for human and veterinary use for 5 additional years, according to a joint statement from the organizations. The initial arrangement was signed in September 2003.

The confidentiality agreement allows the agencies to exchange information as part of their regulatory processes, the announcement said. The types of information covered by the arrangement include legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorization procedures and post-marketing surveillance, the statement said.