Pilot Programs Facilitate Successful International Regulatory Collaborative Efforts, FDA Reports

August 11, 2011 12:24 pm

Food and Drug Administration (FDA) reports that two pilot programs involving prescription drug regulatory agencies of Europe and Australia have been successful in increasing international collaborations aimed to enhance drug quality and safety on a global basis. Two reports detail the success of the pilot programs. First, under the Good Clinical Practice (GCP) pilot program, FDA and the European Medicines Agency (EMA) exchanged documents and collaborated on inspections of clinical drug trials. The success of this information-sharing initiative is a foundation for more efficient use of limited resources and improved inspectional coverage, and “demonstrates how the agencies can work together to improve human subject protection and better ensure the integrity of data submitted as the basis for drug approvals,” as noted in an FDA press release. The second pilot, the Active Pharmaceutical Ingredients initiative, involved information-sharing among the FDA, EMA, Australia’s Therapeutic Goods Administration, France, Germany, Ireland, Italy, the United Kingdom, and the European Directorate for the Quality of Medicines & Healthcare. Over the course of 24 months these “participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine collaborative inspections.” FDA reports that it used information provided to inform decisions about when inspections were needed and also to prohibit imports into the United States in one instance.

These pilot programs are part of the FDA’s global strategy to ensure the safety and quality of imported products as introduced in the agency’s June 2011 report, "Pathway to Global Product Safety and Quality." The reports on the pilot programs, “Report on the Pilot EMA-FDA GCP Initiative, September 2009 – March 2011” (PDF) and “Final Report on the International API inspection Pilot Programme, May 2011,” (PDF) are available for download from the FDA Web site.