The new Regulation aims to harmonise the processing of clinical trials within Europe, as well as create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The Clinical Trial Regulation will replace the Clinical Trials Directive 2001/20/EC once the Regulation has come into force.
The harmonisation of clinical trial application process will involve several administrative changes for both the applicants as well as regulatory authorities. This includes the submission of the application to both the Norwegian Medicines Agency and the Ethics Committee via a new EU portal, also called CTIS (the Clinical Trial Information System). The applicant will receive a joint decision after the assessment of the application has been completed. CTIS will be used throughout the life cycle of a clinical study including amendment notifications, reporting and inspection.
Relevant information will be published on this page from time to time. You can also find updated information about the new portal and regulation on the EMA's webpage, as well as on the European Commission's webpage.
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.
There will be a transition period of up to three years after the regulation has come into force.
- 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.