EMEA and FDA identify priority Transatlantic regulatory projects

Transatlantic joint inspections of American, European Union (EU) and third country pharmaceutical plants are to be piloted by the European Commission, the European Medicines Agency (EMEA) and the US FDA.

This is one of a series of priority projects to improve medicine regulatory co-operation between the EU and the US agreed at a meeting of the Transatlantic Economic Council (TEC) in Brussels.

Regarding third counties, US and EU representatives agreed to jointly check standards at plants manufacturing active pharmaceutical ingredients. The decision was welcomed in a joint communique as "an example of close and productive collaboration to the benefit of citizens".

The three institutions have also agreed to pilot the exchange of inspection schedules, results and information on inspected manufacturing sites. This, they said, would help "attain more GMP inspection coverage collectively" and better identify third country pharmaceutical ingredient manufacturing sites.

Meanwhile, there was an agreement to collaborate over determining the necessity for "dedicated production facilities..for certain pharmaceuticals", with a revised EU guideline being proposed in early 2009. In addition, EMEA and the FDA are to continue work on biomarker development and validation.

The next TEC will be staged in autumn 2008.