Regulatory agencies to share commercially confidential information

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) will begin sharing non-public and commercially confidential information, as reported by the Regulatory Affairs Professionals Society (RAPS).

This recent announcement comes as part of the agreement formed by the regulatory agencies earlier this year whereby each agency would recognise the other’s inspections of pharmaceutical manufacturing facilities. Through this agreement, it is hoped that supplication of inspections may be avoided and as such save money for both agencies.

The agreement will allow full inspection reports to be shared between the agencies, although confidentiality of non-public information will be protected. Additionally, the EMA has stipulated that the FDA will need to sign confidentiality agreement with each EU country prior to receiving any unredacted inspection reports. According to the piece from RAPS, the FDA anticipates these agreements can be made quickly.