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The new CTR (Clinical Trial Regulation) No 536/2014 will repeal the existing Clinical Trial Directive No 2001/20CE on the 31st of January 2022.

It’s impossible to summarize all changes that come along with this new regulation in one sentence, however one major change will be the implementation of the new CTIS (Clinical Trial Information System).

This new portal will be implemented to centralize the submission of a clinical trial in all EU Member States and the EEA. It will replace the existing system of different national rules with one harmonised approach across Europe.

Sponsors will have one year to begin using CTIS, and can decide whether to submit a new clinical trial application under the current Clinical Trial Directive or the new Clinical Trial Regulation until 31 January 2023.

ExperTrials is already preparing for the upcoming changes with a major SOPs revision and employee trainings to be ready on the 31st of January 2022.

Learn more about the new directive on https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation#aims-and-key-benefits-of-the-regulation-section