FDA Can Share Trade Secrets with EU, EMA

The European Medicines Agency (EMA) says that a new confidentiality commitment among it, FDA, and the European Union (EU) will allow FDA to share non-public and commercially confidential information, including trade secret information relating to medicine inspections, with EU regulators. “This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and it aims to strengthen the EU-U.S. relationship,” the EMA says in a news statement. “Ultimately, it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health.”

The EU and the U.S. have had confidentiality agreements in place since 2003, the statement says, allowing for the exchange of confidential information as part of their regulatory and scientific processes. However, complete exchange of information was not possible under those arrangements.