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Strengthening EU-US cooperation in medicine inspections

September 11, 2017

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. 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-US relationship. Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health.

See News Release  European Medicines Agency News 23 August 2017