Report on the joint Good Clinical Practice (GCP) Inspection Pilot Programme

Two pilot programmes of collaboration on inspections between the European Medicines Agency (EMA) and its international partners in the United States and Australia have concluded successfully, according to two reports recently published. The two programmes focus on increasing international regulatory collaboration among the regulatory agencies so that drug quality and safety can be enhanced globally.

The report on the joint good clinical practice (GCP) inspection pilot programme details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the joint GCP inspection pilot, the EMA and the US Food and Drug Administration (FDA) exchanged more than 250 documents relating to 54 different medicines and, in conjunction with the GCP inspectors of the EU Member States, organised 13 collaborative inspections of clinical trials. This lays the foundation for a more efficient use of limited resources, improved inspectional coverage and better understanding of each agency's inspection procedures. It demonstrates how the agencies can work together to improve the protection of participants in clinical trials and better ensure the integrity of data submitted as the basis for drug approvals.

The pilot programme involved the exchange of considerable amounts of information and the establishment of inspections carried out jointly by the agencies. This led to increased levels of understanding between the agencies, and a greater number of inspections of value to more than one authority.

The Pilot EMA/FDA Good Clinical Practice Initiative ran from September 2009 to March 2011.

Source: EMA Press Release