FDA and EMA to share complete inspection reports

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment, a move that will see increased collaboration in the area of medicine manufacturing site inspections.  The FDA will now share full inspection reports that contain non-public and commercially confidential information with the EMA and European Commission.

This is a big step forward from the previous agreement which has, for the last 14 years, permitted that sharing of some but not all confidential information on regulatory and scientific processes.

This strengthening of the EU-US relationship should result in a more efficient use of each agency’s inspection resources.  It will permit the agencies to base their decisions on findings of the other’s inspections.

In the future, it should be possible for the FDA to share complete inspection reports with EU national competent authorities, provided a similar confidentiality commitment is put in place.  The FDA is instigating negotiations for such an agreement with EU member state and expects that these should be swiftly put in place.

From industry’s perspective, in time there should be a reduction in the need for a manufacturing site to be inspected by both the FDA and the EMA or a national EU authority.

Click here to access the EMA announcement.