Posted by Michael Wonder on 24 Aug 2017
FDA, EMA and EC sign new confidentiality commitment
24 August 2017 - The US FDA can now share non-public and commercially confidential information, including trade secrets relating to medicines inspections, with EU regulators after the parties signed a new commitment.
The confidentiality commitment, signed by the FDA, the EMA and the European Commission, is “a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers”, and aims to strengthen ties between the EU and US, according to the EMA.
“Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health,” it noted.
