Posted by Michael Wonder on 23 Aug 2017
Strengthening EU-US cooperation in medicine inspections
23 August 2017 - New commitment allows FDA to share full inspection reports with European Commission and EMA
The European Commission, the US FDA and the EMA have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and it aims to strengthen the EU-US relationship. Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health.
The EU and the US have had confidentiality arrangements in place since 2003, allowing for the exchange of confidential information as part of their regulatory and scientific processes. However, complete exchange of information was not possible under these arrangements.
