Drug Inspection Pilots Successful
The FDA and international counterparts recently released the results of pilot programs meant to enhance drug safety globally.
The U.S. Food and Drug Administration, together with its European and Australian counterparts, today released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.
The report on the Good Clinical Practice (GCP) initiative details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the GCP pilot program, the FDA and the European Medicines Agency (EMA) exchanged more than 250 documents relating to 54 different drug products and, in conjunction with the GCP inspectors of the EU 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 human subject protection and better ensure the integrity of data submitted as the basis for drug approvals.
The report on the Active Pharmaceutical Ingredients initiative details the success of information-sharing among the FDA, Australia’s Therapeutic Goods Administration and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM). Over the course of the 24 month pilot phase, the 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. The FDA used these reports to inform decisions, such as whether to postpone or expedite its own inspection. The FDA also prohibited imports into the U.S. of a firm’s products based on the negative findings from a European inspection. The information-sharing and collaborative inspections were important milestones in establishing a sense of mutual trust and common purpose among the drug regulatory agencies involved.
“It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone,” said Deborah M. Autor, FDA deputy commissioner for Global Regulatory Operations and Policy. “We are grateful to our European and Australian colleagues for their willingness to partner with us in these pilot programs. The pilots are important stepping stones toward further global regulatory collaboration.”
These pilot programs are part of the FDA’s global strategy to ensure the safety and quality of imported products. The new strategy builds on efforts that are currently underway at the FDA. The agency increased the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009 and has opened several international offices in key locations such as China and India. The FDA has been an active contributor in the effort to harmonize certain aspects of drug regulation via the International Conference on Harmonization, and the agency recently joined the Pharmaceutical Inspection Cooperation/Scheme, an organization of drug manufacturing inspectorates from 39 countries.
In June, the FDA unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the "Pathway to Global Product Safety and Quality." The FDA report calls for the agency to transform the way it conducts business, to build upon its ongoing collaborations with its regulatory partners around the world, and to act globally in order to promote and protect the health of U.S. consumers. In the report, the FDA says that it will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality. FDA looks forward to working with its counterparts on this important effort.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.