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# FDA, European Regulators Back GCP Inspection Collaboration
- URL: https://www.fdaweb.com/fda-european-regulators-back-gcp-inspection-collaboration/
- Published: 2022-08-19T12:00:00.000Z
- Updated: 2026-09-14T17:56:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152547

A new research article by FDA and European regulators finds their good clinical practice (GCP) inspection processes to be equivalent, which supports an ongoing inspection collaboration and inspection document sharing pact. Writing in the 8/16 online [*Therapeutic Innovation & Regulatory Science*](https://link.springer.com/journal/43441?ref=fdaweb.com) journal, the regulators said they analyzed 55 shared applications — 28 of which included common sites inspected by both agencies. There were 15 joint inspections conducted for seven of these applications and the remaining applications had common sites inspected by both agencies at separate times.

“The median time from submission of an application to generation of final inspection reports was 232 days for FDA and 204 days for the EMA \[European Medicines Agency\], with no significant differences noted among applications with and without common sites,” they write. “The inspection processes and timelines between the two agencies were similar, providing support for continued FDA-EMA GCP collaboration.

The FDA/EMA GCP collaboration includes bimonthly meetings to discuss the status and/or findings from inspections for shared applications, exchanging inspection documents, and identifying sites for potential joint or observational inspections.