FDA, EU regulators agree to share unredacted inspection reports and other confidential information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators.  The new confidentiality commitment allows the regulators to share commercially confidential information, trade secret information, personal data and other non-public information relating to drug inspections and investigations.  This commitment furthers ongoing implementation of the EU and FDA agreement on mutual recognition of inspections of drug manufacturers announced earlier this year (discussed in our prior post), and strengthens the EU and US relationship by promising to maintain the confidentiality of exchanged non-public information.

Read more: FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

Download PDF Back To Listing