FDA works with international regulators to exchange inspection information and enhance clinical trial oversight. FDA and the European Medicines Agency (EMA) collaborated with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to conduct an 18-month pilot on good clinical practice (GCP) collaboration to assess the feasibility of including PMDA in the existing EMA and FDA GCP collaboration.
The main objectives of the pilot were to evaluate the timing of GCP inspection milestones and identify best practices in GCP process and procedure. As a result of the pilot, PMDA will be an official member of the GCP initiative and continue in the collaboration.
This collaboration will promote effective GCP inspections globally and will allow more efficient use of limited resources through continued information exchange and sharing of inspectional findings.