BioCentury
ARTICLE | Politics, Policy & Law

EC pharmaceutical regulatory reform plan

April 15, 2002 7:00 AM UTC

EU Commissioner Erkki Liikanen last week outlined the Commission's plans for reform of the EU's pharmaceutical legislation. The Commission's key proposals are the introduction of fast-track registration, conditional marketing authorization, and removal of the marketing authorization renewal procedure. For patients, the Commission wants to provide more transparency and access to data on the Internet.

In a speech before the Mentor Group Forum for U.S.-EU Legal-Economic Affairs, Liikanen said the Commission's objective was to continue to guarantee a high level of health protection, to ensure access to high quality medicines, and to rationalize and simplify the regulatory process, while making it more transparent for both companies and patients. ...