Remember the Clinical Trials Regulation? Much time has passed since its publication in 2014. No worries if your memory fails you: we have discussed the Clinical Trial Regulation at length in this article appeared on the Indian Law Journal of Law and Technology. If you prefer a shorter summary, you may read here what the European Medicines Agency has prepared for you.
The actual entry into force of the Clinical Trials Regulation depended on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit, which occurred on April 21, 2021. Now, the go-live date for the CTIS will be on January 31, 2022. Information on the go live planning can be found here.
The Clinical Trials Regulation was born to address the prior directive’s shortcomings, and particularly to target the goals of harmonization and simplification in this field, also with a view of making Europe a competitive region in the global clinical trials market. Good luck to the CTIS: we hope the Clinical Trials Regulation keeps its promises!