EU and USA in Medicines Inspections Pact

The European Commission, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have signed an agreement enabling them to share non-public and commercially confidential information, including trade secrets relating to medicines inspections.

The EMA said it is “a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and aims to strengthen the EU-US relationship.” The agency added that ultimately the deal will contribute to a more efficient use of regulators’ inspection resources for protecting human and animal health.

The new commitment now permits the sharing of full inspection reports, allowing regulators to make decisions based on findings in each other’s reports and to make better use of their inspection resources to focus on manufacturing sites of higher risk.

Transatlantic arrangements that allow confidential information to be exchanged as part of regulatory and scientific processes have been in place since 2003, but complete exchange of data, including full inspection reports, has not been possible until now.

In March of this year, EU and US regulators agreed to recognize each other’s inspections of medicines manufacturing sites conducted in their respective territories, freeing up their resources to focus on other parts of the world. The EMA said about 40% of finished medicines marketed in the EU originate overseas and 80% of manufacturers of APIs used in EU medicines are located outside the Union.