The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a draft guideline on requirements for first-in-man clinical trials for potential high risk medicinal products. This draft guideline is being released for a two month public consultation period.

 

The press release can be found here.
The draft guideline can be found here.
Comments are invited by 23 May 2007 and should be submitted using the template available here.