FDA & EMEA to increase cooperation

The Transatlantic Economic Council (TEC) has set out its vision of how increased cooperation between the US and European Union can improve the pharmaceutical regulatory process.

Guidelines for collaboration between the US Food and Drug Administration (FDA), the European Commission and the European Medicines Agency (EMEA) were agreed at the TEC's second meeting.

With the regulatory bodies having to monitor an increasingly diverse global industry, the TEC believes it makes sense for the big regulatory bodies to pool resources.

One specific aspect of this broad policy is the launching of a pilot scheme for joint FDA and EMEA inspections of pharmaceutical manufacturing facilities in the US and EU.

In addition it is proposed that the two regulatory bodies undertake joint inspections of active pharmaceutical ingredient (API) facilities in countries outside of the EU and US.

 

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Transatlantic Economic Council

 

The Transatlantic Economic Council is a political body to oversee and accelerate government-to-government cooperation with the aim of advancing economic integration between the European Union and the United States of America.

At the last EU-US Summit on 30 April 2007, Commission President Barroso, German Chancellor Merkel and US President Bush signed the "Framework for Advancing Transatlantic Economic Integration between the United States of America and the European Union"

Key elements of this framework were the adoption of a work programme of cooperation and the establishment of the Transatlantic Economic Council (TEC) to oversee, guide and accelerate the implementation of this work programme.