FDA, EU, Australia Report on Collaborative Drug Inspection Pilots
The Food and Drug Administration and its European and Australian counterparts have released reports detailing the results of two pilot programs on Active Pharmaceutical Ingredient (API) and Good Clinical Practice (GCP), which focused on increasing international regulatory collaboration to enhance drug quality and safety.
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Shared Info from API Pilot Helped FDA in Inspections, Import Decisions
The report on the API pilot details inspections of manufacturers over 24 months (December 2008 - 2010) involving authorities from the U.S., Europe, and Australia1. The participants shared their surveillance lists and found 97 API inspection sites in 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.
GCP Pilot Led to FDA & EMA Info on 54 Drugs, 13 Clinical Trial Inspections
The report on the GCP Pilot states that over 18 months (September 2009 - March 2011), the FDA and European Medicines Agency (EMA) exchanged more than 250 documents relating to 54 different drug products and conducted 13 collaborative inspections of clinical trials. According to the report, the inspections have contributed greatly to each agency’s understanding of the other’s inspection procedures and have led to the identification of potential improvements to these procedures.
1FDA, 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).
(Press release dated 08/02/11)
The API report is available here.
The CGP report is available here.
FAQs on the CGP report are available here.