The Regulation (EU) No 536/2014 of the European Parliament, and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, will be applied effectively as of January 31st, 2022 because of the need for the development of a fully functional EU clinical trials portal and database. The Regulation aims to ensure a greater harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via...MORE >