The US Food and Drug Administration 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 European Medicines Agency 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.
Transatlantic confidentiality arrangements, allowing for the exchange of confidential information as part of regulatory and scientific processes, have been in place since 2003, but complete exchange of data, including full inspection reports, was not possible until now.
The new commitment will allow regulators to make decisions based on findings in each other’s inspection reports and to make better use of their inspection resources to focus on manufacturing sites of higher risk.