EMA and FDA share inspection reports

EMA and FDA share inspection reports

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

Recently, FDA and EMA have signed a new confidentiality commitment that allows the sharing of information on inspections. The confidentiality commitment, which was announced on 23.Aug.2017, allows the regulators to share non-public and commercially confidential information including trade secret information relating to medicines inspections. This will contribute to a more efficient use of inspection resources, and also to strengthen the EU-US relationship.

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