Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“Regulation”) came into force on 31 January 2022.
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“Regulation”) came into force on 31 January 2022. The Regulation was adopted by the European Parliament in 2014 and released in May of the same year. It was subsequently officially published in the Official Journal of the European Union on 31 July 2021 and came into force six months after that date. The Regulation repeals Directive 2001/20/EC and makes sweeping changes to the European rules on conducting clinical trials...