Strengthening EU-US cooperation in medicine inspections

New commitment allows FDA to share full inspection reports with European Commission and EMA

The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators.

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

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