EU approves draft clinical trial rules
The European Parliament and EU Committee of Permanent Representatives, which comprises ambassadors of the 28 member states, approved on Friday draft legislation on rules for conducting clinical trials in the EU. While the goal of the legislation was to make it easier for sponsors to conduct multinational clinical trials in Europe, the final document is a compromise. Health Commissioner Tonio Borg said the European Commission had "hoped for a more ambitious approach in line with its original proposal."
The draft legislation provides a single portal for registration of European clinical trial applications; registration via the portal will be a prerequisite for assessment of any application. There will be a single authorization procedure for all clinical trials. ...