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FDA and EMEA to continue cooperation

The FDA and the EMEA are expanding their cooperation activities to cover paediatrics and orphan drugs

The FDA and the European Medicines Agency (EMEA) are expanding their cooperation activities to cover paediatrics and orphan drugs.

Previously, the two organisations shared information on vaccines, oncology and pharmacogenomics.

The FDA also says scientific dialogue has been widened to include extensions of therapeutic indications and risk management plans.

The new agreement, the Framework for Advancing Transatlantic Economic Integration between the EU and the FDA, follows the adoption of paediatric legislation in the EU, and a ëPrinciples of Interactions' document that will facilitate the exchange of information on scientific and ethical issues for paediatric therapeutics has been finalised.

It states that information will be exchanged on product-specific paediatric development and waivers from the obligations to perform such paediatric development. Information will also be exchanged on general issues related to paediatric development such as early draft guidance documents, and safety issues such as adverse drug reactions and statistics.

Following the agreement, new areas of transatlantic regulatory cooperation have also been discussed, including regulatory cooperation on medical devices and cosmetics, and these will continue.

Several drugs, such as Novartis' IBS drug Zelnorm/Zelmac (tegaserod) and sanofi-aventis' obesity drug Acomplia (rimonabant), have been approved by one regulatory body and rejected by another. Zelnorm/Zelmac has twice been rejected by the EMEA because of the increased risk of cardiovascular conditions, but was approved by the FDA. The FDA banned the drug last month.

Acomplia was approved by the EMEA in 2006, but last week the FDA rejected it over an increased suicide risk. 

In an effort to avoid future disharmony, upstream regulatory cooperation on new medicines legislation was discussed. A Transatlantic Workshop on Administrative Simplification in Medicines Regulation is planned for 28 November 2007 in Brussels, Belgium.

20th June 2007


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