The Clinical Trials Regulation foresees a 3-year transition period to CTIS.

  • From 31 January 2022 until 31 January 2023, clinical trial sponsors can choose to submit their clinical trial applications under the Clinical Trials Directive (EC) No. 2001/20/EC through national submission processes, or under the Clinical Trials Regulation through CTIS.
  • From 31 January 2023 all new clinical trial applications in the EU and EEA must be submitted under the Clinical Trials Regulation through CTIS.
  • From 31 January 2025 trials approved under the Clinical Trials Directive that are still ongoing will have to be transferred to the Clinical Trials Regulation and to CTIS.
EU Member States and EEA countries will have to work in CTIS from go-live, once applications are submitted.​

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

EudraLex - Volume 10 - Clinical trials guidelines

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.

Oppdatert: 20.12.2021

Publisert: 06.08.2021

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