FDA Agrees to Share Full Inspection Reports With the European Union

The FDA has signed a new confidentiality agreement with the European Commission (EC) and the European Medicines Agency (EMA). The agreement will allow the FDA to share with the EC and EMA nonpublic, commercially confidential information (including trade secrets) related to inspections.

FDA commissioner, Scott Gottlieb, MD, took to Twitter to hail the aggreement, saying that it would lead to more efficient manufacturing site inspections:

The FDA has maintained confidentiality agreements with European regulators since 2003, which have allowed for the exchange of information as part of the regulatory and scientific process. However, the FDA could not, under previous arrangements, share full inspection reports.

The EC’s directorate general certified that neither it nor the EMA would disclose to the public any confidential, personal, law enforcement, national security, or pre-decision information shared in confidence. The European agencies may, however, share information received from the FDA with the regulatory agencies of individual EU member states, but only if those states have made prior arrangements with the FDA. The FDA also assured the European Union’s (EU) agencies that it would take all necessary steps to prevent confidential information from being publicly disclosed.

The new agreement is part of a larger plan regarding mutual recognition of inspections. The plan, designed to reduce duplication of efforts, allows US and EU regulators to rely on one another’s inspection reports on good manufacturing practices in their own territories. As of a March agreement to mutually recognize inspections of manufacturing facilities on both sides of the Atlantic, European inspections of US facilities, and vice versa, are limited to “exceptional circumstances.”

The respective agencies, which have comparable regulatory and procedural frameworks for the inspection of facilities, hope that the overall plan will allow regulators to make better use of their resources. The EU already uses mutual recognition frameworks with other regulatory agencies, such as those located in Australia, New Zealand, Canada, Japan, and Switzerland.

In preparation for an agreement with the United States, the EU invited the FDA to observe the EU’s Joint Audit Programme, a framework in which 2 EU member states audit the regulatory agency of another member state. FDA observed the audit of Sweden’s inspectorate by the United Kingdom and Norway, and observed an additional 13 audits before solidifying its own agreement with the EU.

The FDA’s associate commissioner for global regulatory policy, Dara Corrigan, called the March mutual recognition agreement “an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high-quality drugs.”