EMEA and FDA launch GCP initiative

The European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have agreed to collaborate on international Good Clinical Practices (GCP) inspection activities. The objectives of the initiative include sharing information on inspection planning, policy and outcomes and the conduct of collaborative inspections.

The EMEA and the FDA will start their new initiative with an 18-month pilot phase on 1 September 2009.

Thomas Loenngren, executive director of the EMEA, said the initiative 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," he said.

"This important effort will help to strengthen safeguards for participants and others involved in clinical studies," added Margaret Hamburg, the FDA's commissioner of food and drugs.

Key objectives of the FDA-EMEA GCP initiative will be:

To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.

To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.

To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.

Following the pilot, a joint assessment will be made by the EMEA and FDA, with the scope and process modified and amended as needed.

Applicants interested in volunteering to participate in a collaborative inspection during the pilot phase can contact the EMEA or FDA.