FDA Issues Reports on International Collaboration

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Agency reports on pilot programs to increase international regulatory collaboration.

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Two recent reports highlight strategies for improving international cooperation over the regulation of drug manufacturing.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have collaborated in recent years in sharing inspection reports in order to better understand each other’s inspection practices.  These efforts are a part of a larger strategic plan by the FDA to increase its foreign partnerships over the next decade in response to the increasing globalization of drug development.

One report described information sharing between the FDA and the EMA over applications for new drugs and inspections of clinical trial sites. The FDA and EMA periodically inspect sites that perform clinical trials in order to ensure the safety of the participants and the accuracy of the resulting data.

According to the report, pharmaceutical companies often apply for approval of a new drug in both the US and Europe, using the same clinical trial data to support both applications. Historically, agencies have performed their monitoring independently, which sometimes results in duplication of effort.  By coordinating inspection information through e-mail, teleconferences, and in-person meetings, agencies hope to perform their monitoring duties more efficiently while reducing the regulatory burden on production facilities. The FDA report also identified several differences in inspection protocols between the FDA and EMA that may limit the extent to which the two agencies can interpret each other’s reports.

Both agencies considered the pilot program to be productive, noting the exchange of over 250 documents related to drug applications and thirteen collaborative site inspections. The FDA is considering expanding the program to include more classes of regulated products, such as vaccines.

An earlier report summarized a similar but broader program established by the FDA, EMA, and several national counterparts in Europe and Australia. Here, the agencies focused on sharing information from inspections of manufacturers of “active pharmaceutical ingredients,” substances which confer pharmacological activity to a drug. The various national agencies in this earlier pilot project also shared inspection reports as well as conducted joint inspections.

According to the earlier report, these efforts were viewed by the participating agencies as “promising.”  The report noted that participating agencies “in principle” support continuing and extending the project to include more countries.