Borg welcomes deal on new EU clinical trials regulation
The new regulation includes significant reforms that will boost clinical research in Europe
The European Union’s (EU) Health Commissioner, Tonio Borg, has welcomed a deal struck by member states over revising the EU’s clinical trials regulation.
Noting that this was an 'important text for people's health and EU competitiveness', he said the agreement by the EU’s Coreper committee of senior national government officials would enable the European Parliament to approve the law ahead of May’s elections.
Borg said that while the Commission 'would have hoped for a more ambitious approach', the new regulation includes significant reforms 'which will…boost clinical research in Europe'.
He stressed that it would:
- Introduce a streamlined application procedure via an EU Internet portal and database, for all clinical trials conducted in Europe;
- Create a single authorisation procedure for all clinical trials;
- Extend the ‘tacit agreement’ principle to the whole authorisation process, giving sponsors, researchers and companies clearing initial market approval hurdles 'more legal certainty' about a final regulatory decision;
- Improve procedures for conducting multinational clinical trials;
- Strengthen rules on protecting patients, notably through informed consent requirements;
- Increase transparency on the conduct and results of the clinical trial through compulsory prior registration on the EU portal; and
- Enable the Commission to conduct controls in member states and non-EU countries to 'ensure…rules are being properly supervised and enforced'.