FDA, EMEA, and European Commission Set First Goals in Med Regulation

Brussels, Belgiuim (May 23)-The transatlantic cooperation of the European Commission, the European Medicines Agency, and the US Food and Drug Administration was recognized at the Second Meeting of the Transatlantic Economic Council (TEC), held mid May in Brussels. The TEC is tasked with overseeing and accelerating government-to-government cooperation to advance economic integration between the United States and the European Union.

At the meeting, it was announced that the agencies have agreed on the first set of projects on medicinal products. These priority objectives comprise the following:

• The European Commission, EMEA, and FDA will pilot joint inspections of companies manufacturing pharmaceuticals in the US and in the EU and of companies manufacturing active pharmaceutical ingredients in third countries.

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

• The European Commission, EMEA, and FDA 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.

• EMEA and FDA have recently announced successes in their transatlantic work on biomarker development and validation for various product development purposes. Both parties will continue to work on this initiative with further biomarker development and validation.

According to the TEC announcement, “the collaboration  on inspections should result in more effective use of resources and a higher safety level of products from third countries.”