The US and Europe Commit to Cooperating on Inspections

August 23, 2017

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

On August 23, 2017, the European Medicines Agency (EMA) announced that FDA, EMA, and the European Commission have signed a new confidentiality commitment. This commitment will allow FDA to share non-public and commercially confidential information with regulators in the European Union. This step will strengthen the EU–US effort to create more efficient use of inspection resources.

The confidentiality commitment will let the agency share information, including trade secret information that relates to inspections of medicines by EU regulators. While the EU and US have had these sorts of agreements in place since 2003, previous agreements did not allow for complete exchange of information.

“The new confidentiality commitment formally recognizes that FDA's EU counterparts have the authority and demonstrated ability to protect the relevant information. This step now allows the sharing of full inspection reports, allowing 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,” EMA stated in a press release.

Source: EMA