EU CTR - EudraLex Volume 10: : Harmonisation guidance published

Dear Colleagues,

The European Commission has recently published Harmonisation guidance to the website EudraLex - Volume 10 - Clinical trials guidelines.

This is a general guidance which relates to a set of harmonised documents which have been endorsed by the EU Clinical Trial Expert Group. It is aimed at supporting sponsors of Clinical Trials when submitting applications under Clinical Trials Regulation (EU) No 536/2014.

1 Like