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Focus on Regulation

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.

A complete exchange of such information, including unredacted inspection reports, was not possible under previous confidentiality agreements among the regulators.  The FDA, the EMA and DG Sante provided reciprocal warranties concerning the confidentiality of the information exchanged under the new arrangement.  In particular, the EMA and DG Sante are entitled to share the information provided by the FDA with the EU Member States’ authorities only if these authorities and the FDA have concluded an arrangement convening the exchange of the same information.  The commitment could lead to decisions based on findings from inspections conducted within the other regulator’s borders.  This coordination effort allows regulators to reallocate resources to focus on drug inspections with potentially higher public health risks outside of the U.S. and EU, which is consistent with the increasing focus on inspections in China, India, and Asia more broadly.