BioCentury
ARTICLE | Regulation

Europe's fast-track plan

July 23, 2001 7:00 AM UTC

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...