Closer regulatory co-operation between the EU and the US

A recent statement by the Transatlantic Economic Council (TEC), a joint EU/US initiative set up last year, points to a closer future relationship between regulatory authorities in the EU and the US.

At the TEC in May, the work of the European Commission, the European Medicines Agency and the US FDA on medicines regulation was noted as an example of close and productive collaboration between the regulatory agencies of the parties.

The TEC noted especially the further strengthening of transatlantic co-operation on medicines regulation. A first set of projects on medicinal products has been agreed following an administrative simplification workshop held in Brussels in November 2007.

Among specific priority projects that have been agreed are:

• Piloting of joint inspections of companies manufacturing pharmaceuticals in the US and in the EU and of companies manufacturing active pharmaceutical ingredients in third countries.
• Piloting 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.
• 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.

A statement from the parties says that 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 on this collaboration, which is welcomed by industry, 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 2007. Developments will be discussed here as they occur.