The European Commission has published three recommendations for the clinical trials regulation
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)