FDA, EMA Now Share Confidential Information

Aug 23, 2017


The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) will start sharing non-public and commercially confidential information, including trade secret information, according to RAPS.

Back in March, the agencies announced their agreement to recognize each other's pharma manufacturing inspections, with the goal of reducing duplicate inspections and lowering costs for both regulators.

Dara Corrigan, FDA's acting deputy commissioner for global regulatory operations and policy, promised that the FDA will protect non-public information from public disclosure. EMA's Executive Director Guido Rasi says EMA may share some information received from FDA with the European Commission's Directorate-General, as well as EU member state regulators, the article said.

Read the full story