​​On 31st July 2021, the European Commission confirmed the entry into application of the Clinical Trial Regulation (EU) No 536/2014 by the publication of a notice in the Official Journal of the European Union. As set out in the Regulation, this publication starts the six-month countdown to CTIS go-live and confirms the go-live date for CTIS as 31st of January 2022.​

The Clinical Trials Regulation foresees a three-year transition period. Member States will work in CTIS immediately after the system has gone live. For one year, until the 31st of January 2023, applicants can still choose whether to submit their application to start a clinical trial according to the current system (Clinical Trials Directive) or according to the Clinical Trials Regulation. 

From the 31st of​ January 2023 onward, submission according to the Clinical Trials Regulation becomes mandatory and by the 31st of January 2025, all ongoing trials approved under the current Clinical Trials Directive will need to transition to the new Regulation and to CTIS.

For further information regarding the transition period, please see Chapter 11 of CLINICAL TRIALS REGULATION (EU) NO 536/2014 QUESTIONS & ANSWERS.

Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials. At present, both documents applicable to clinical trials authorised under Directive 2001/20/EC (i.e. the current applicable documents) and documents relevant to clinical trials authorised under Regulation (EU) No 536/2014 can be found listed in two separate pages on the Eudralex Volume 10 website.

During the transitional period, both sets of documents will apply accordingly and should be referred to respectively according to the legislation under which the Clinical trial is conducted.

At the end of the transitional period, all clinical trials shall be conducted under the Regulation and follow the set of documents applicable to the Regulation.

For further information, please see the EudraLex Volume 10 webpage.

Publisert: 06.08.2021

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