Europe and U.S. Regulators Increase Cooperation on Inspections

The European Commission, the FDA, and the European Medicines Agency (EMA) have signed a new confidentiality agreement that allows regulators on both sides of the Atlantic to share non-public and commercially confidential information, including trade secrets about inspections.

News from Applied Clinical Trials:

The new agreement formally recognizes that FDA's EU counterparts have the authority and demonstrated ability to protect the relevant information, according to the EMA statement.

“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.”

Posted by Dr. Tim Sandle