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TRANSATLANTIC ECONOMIC COUNCIL NOTES STRENGTHENED COLLABORATION ON MEDICINES REGULATION

At the May 13 th Transatlantic Economic Council (TEC) (link) the work of the U.S. Food and Drug Administration, the European Commission, and the European Medicines Agency on medicines regulation was noted as an example of close and productive collaboration to the benefit of citizens.

The TEC noted especially the further strengthening of transatlantic cooperation on medicines regulation. Highlighting this further strengthening of regulatory cooperation was the announcement that a first set of projects on medicinal products have been agreed following the administrative simplification workshop held in Brussels in November 2007 (link).

More specifically the following specific priority projects have been agreed:

1. The FDA and the Commission/EMEA will pilot joint inspections of companies manufacturing pharmaceuticals in the U.S. and in the EU and of companies manufacturing active pharmaceutical ingredients in third countries.



2. The FDA and the Commission/EMEA will pilot the exchange of inspection schedules, results, and information on inspected manufacturing sites in order to attain more GMP inspection coverage collectively and to better identify manufacturing sites producing active pharmaceutical ingredients in third countries.



3. The FDA and the Commission/EMEA will step up collaboration to determine to what extent dedicated production facilities are necessary for certain pharmaceuticals taking into account a risk based approach. Subsequently, it is expected that a revised EU guideline will be published for public consultation in the first quarter of 2009. FDA is also in the process of clarifying this issue through proposing amendments to existing regulations and draft guidances that are in the process for issuance.



4. The FDA and the EMEA have recently announced successes in their transatlantic work on biomarker development and validation for various product development purposes ( link to specific part of EMEA site) . Both parties will continue to work on this initiative with further biomarker development and validation.

These results will provide important benefits for industry and patients. It is of particular note that the collaboration on inspections should result in more effective use of resources and a higher safety level of products from third countries.

Work is continuing to identify other items of intensified regulatory collaboration for mutual benefit and this will include further action points from the administrative simplification workshop held in Brussels in November 2007 .

Finally, the FDA and the EMEA have agreed recently on an implementation work plan for veterinary medicinal products regulation and have agreed on a process for offering parallel scientific advice to veterinary medicinal products manufacturers that wish to receive such advice simultaneously from the FDA and EMEA.

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