EMA, FDA and international counterparts complete successful inspection pilots

Two pilot programs of collaboration on inspections between the European Medicines Agency, the US Food and Drug Administration and the Australia Therapeutics Goods Administration have concluded successfully, according to two reports published yesterday. The two programs 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 program details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the joint GCP inspection pilot, the EMA and the FDA exchanged more than 250 documents relating to 54 different medicines and, in conjunction with the GCP inspectors of the European Union member states, organized 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.

Success of information sharing on APIs