12:00 AM
Jul 23, 2001
 |  BioCentury  |  Regulation

Europe's fast-track plan

The European Commission last week adopted legislation designed to rationalize and speed the approval of drugs in the European Union. The proposed new law would put in place procedures for approving biotechnology, pharmaceutical, and generics drugs that more closely resemble U.S. policy, and are explicitly aimed at elevating Europe's competitiveness in the world market for pharmaceuticals.

According to Erkki Liikanen, European Commissioner responsible for Enterprise and the Information Society, the EC's goal is to perform reviews of major new medicines on a pace "as fast, if not faster than those performed by the U.S. FDA." Overall, the EC wants all product review times to fall below one year.

"They've really tried to create a way to make the EU more competitive on the global scene," said Andrea Rappaglosi, vice president of health policy and government relations at Serono S.A. (SRA; SWX:SEO, Strasbourg, France). "The fast track procedure is much closer to the accelerated review process at the FDA. It also provides a much better scientific advice procedure that allows companies to have an open and direct dialog with the EMEA before submitting a new compound."

Time to approval

Under the proposed legislation, when a sponsor requests fast track status, the EMEA (European Medicines Evaluation Agency) may grant accelerated review (maximum 150 days compared to the current 210 days) to drugs that are important for human health.

The proposal also provides for "compassionate use" while a drug is still in clinical trials for patients who have no other remaining options.

The plan also aims to improve the efficiency of the drug development process by extending the EMEA's remit to include the supply of scientific advice to product sponsors. "The scope of activities of the EMEA should go beyond the evaluation of medicinal products in the context of the marketing authorisation, by strengthening its role as a scientific adviser," according to the EC. "The EMEA should also be competent to give scientific advice to companies, in particular to small and...

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