Regulatory Focus™ > News Articles > Dalli: Commission Looking to Overhaul Clinical Trials Directive

Dalli: Commission Looking to Overhaul Clinical Trials Directive

Posted 13 March 2012 | By Alexander Gaffney, RAC 

John Dalli, the European commissioner for health and consumer policy, spoke 7 March about the need to review and modernize the Clinical Trials Directive before a joint event put on by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Roche Group.

"This debate comes at a very good time - the Commission will come forward with a proposal to revise the Clinical Trials Directive later this year," said Dalli.

Dalli noted clinical trials have doubled in expense, gotten more complex, experienced increased delays and have suffered a 15% decline in approvals in recent years.

"It is therefore crucial to provide the right regulatory framework," said Dalli.

Dalli outlined several areas he said were under consideration by the Commission, including the authorization process, the submission process, the assessment of clinical trial applications, conflicts of interest, scientific advice and consistency between Member States.

"I would not want to see a new, central bureaucracy developing for clinical trials.  Instead, we need a collaborative, flexible approach," said Dalli. "[W]e want to adopt the revised legislation in the form of a regulation."

Read more:

Commissioner Dalli delivers speech on "Clinical Trials Directive - Meeting Patients' Needs"


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.