EMEA strikes regulatory deal with US FDA

The European Agency for the Evaluation of Medicinal Products (EMEA) and the US FDA have struck a deal on regulatory co-operation, entailing the swapping of advance copies of draft rules, guidance, marketing authorisations and supervision notes. As this deal would involve the transfer of commercially sensitive material, both organisations have agreed to treat such material as confidential. That said, there is a caveat that this is 'to the extent permitted by their respective laws,' including the US Freedom of Information Act.

Other information to be shared between the two bodies includes post-authorisation pharmacovigilance data, quality defect or product recalls, maximum residue guidelines, GMP inspection reports, good clinical practice inquiry papers and notes on information technologies used to support regulatory processes.