The Impact of the New EU Clinical Trial Regulation 536/2014 on CMC Activities

After many years of anticipation, the new Clinical Trial Regulation (CTR 536/2014) supplemented by (EU)2017/1569 which defines GMP requirements for Investigational Medicinal Products (IMPs) was finally implemented on 31 January 2022. This new CTR will replace the European Directive 2001/20/EC. The transition period where studies can be submitted under the directive or the regulation will end on 31 January 2023.