8/9 February 2022
The European Commission (EC), the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment allowing to share non-public and commercially confidential information relating to medicine inspections between inspectorates.
This commitment is an important part in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers (Mutual Recognition Agreement; MRA), which should come into force on 1st November 2017.
Confidentiality arrangements have already been in place since 2003, supporting the exchange of confidential information as part of regulatory and scientific processes. However, complete exchange of information including trade secret information has not been possible yet. Now it will be possible to share full inspection reports.
Source: EMA press release Strengthening EU-US cooperation in medicine inspections