European Regulatory Agencies Update

Peter O'Donnell, the View from Brussels columnist for Applied Clinical Trials, is a freelance journalist who specializes in European health affairs. He is based in Brussels, Belgium.

This was the first full year of the European Union's revised medicines legislation, which came into force late in 2005. New legal provisions gave the European Medicines Agency in London responsibility for evaluating generic and biosimilar medicines, "compassionate use" medicines, medicines for use outside the EU, and "core dossier" applications for pandemic-influenza vaccines. All new medicines for HIV/Aids, cancer, diabetes, neurodegenerative disorders, and "orphan" diseases now have to be submitted through the centralized authorization procedure.

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