The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trials Regulation (CTR) EU No. 536/2014 becomes applicable on January 31, 2022.
The Regulation will replace the existing Clinical Trials Directive (CTD) No. 2001/20/EC and national legislations that were put in place to implement it.
Without a doubt, the Clinical Trials Regulation will change the rules for authorisation of all phases (I-IV) of clinical trials on medicinal products for human use. It will harmonise and centralise the processes from the start to the end of clinical trials.
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