EMEA and FDA To Collaborate on Good Clinical Practice

The US Food and Drug Administration and European Medicines Agency (EMEA) launched this week a joint initiative to collaborate on international good clinical practice (GCP) inspection activities. The key objectives of the initiative include: conducting periodic information exchanges on GCP-related information; conducting collaborative GCP inspections; and the sharing and interpretation of information relating to GCP. The latter objective involves informing each other of related legislation and regulatory guidance.

“This important initiative demonstrates the increasing collaboration between the EMEA and the FDA,” said EMEA Executive Director Thomas Lönngren in a press release. “It marks an important step to the building of a global regulatory network for supervision of clinical trials. By working together in a collaborative and synergistic manner, GCP inspection resources can be used more efficiently.”

In a separate FDA release on the inititive, Murray M. Lumpkin, deputy commissioner for International Programs, said, “This is another initiative that will further strengthen the very robust relationship between the FDA and the EMEA. This will allow both the FDA and the EMEA to leverage each other's GCP inspectional resources so both of us can use our resources to assure more of the clinical trials submitted to both agencies are of the highest quality."

Once the pilot is complete, the two agencies will assess the project and made any needed modifications, according to the FDA release.

Those interested in taking part in a collaborative inspection during the initial pilot phase of the scheme should contact Dr. Ana Rodriguez of the EMEA inspections sector, at GCP@emea.europa.eu or Dr. Leslie Ball of the FDA’s Division of Scientific Investigations in the Center for Drug Evaluation and Research at Leslie.Ball@fda.hhs.gov.

Amelia Tope is an Associate Digital Editor at Pharmaceutical Executive Europe.