News about GMP/cGMP

29.08.2017

EMA and FDA: Sharing of Commercially Confidential Information

The European Medicines Agency EMA, the European Commission and the US FDA have signed a new confidentiality commitment. It enables US and EU regulators to share non-public and commercially confidential information, including trade secret information relating to medicine inspections.

This can be considered a real milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers (we reported) and should strengthen the EU-US relationship.

The new confidentiality commitment formally recognises that FDA's EU counterparts have the authority and demonstrated the ability to protect the relevant information. The sharing of full inspection reports is now possible, 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.