The European Commission has published three recommendations for the clinical trials regulation
14 November 2017
In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.
The following three recommendations have been published on the European Commission’s website in EudraLex - Volume 10:
- Summaries of Clinical Trial Results for Laypersons, January 2017, Chapter V
- Risk proportionate approaches in clinical trials, April 2017, Chapter V
- Auxiliary medicinal products in clinical trials, revision 2, June 2017, Chapter III
(previously the IMPs/NIMPs guideline)