The Clinical Trials Regulation (EU) No 536/2014 becomes mandatory for all initial clinical trial applications
January 12, 2023
End of the first transition period for the new Clinical Trials Regulation
One year after it came into force, the new Clinical Trials Regulation (Regulation (EU) No 536/2014) will become mandatory for all initial clinical trial applications from Member States of the European Union (EU) or the European Economic Area (EEA), which includes the 27 Member States of the EU*, as well as Iceland, Norway and Liechtenstein.
*Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, Germany, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
The CTIS, a link between Sponsors and EU/EEA health authorities
From 31 January 2023, all Sponsors will have to use the Clinical Trials Information System (CTIS), which centralizes the information and databases concerning all clinical trials conducted within the EU/EEA. It should be noted that the public pages of the CTIS can be consulted by all.
Sponsors from all EU/EEA Member States will follow the same procedure to apply for authorization to conduct a clinical trial in 1 to 30 of the EEA Member States, using a single online application.
This initiative will harmonize the submission and evaluation of clinical trials conducted across several Member States, allow the centralization and sharing of product safety data, and increase the level of transparency of clinical trials.
Start of the second transition period
đź“… This is the beginning of the 2nd transition period, lasting until 31 January 2025, when all clinical trials will be transferred to the CTIS, including those initiated before the new regulation came into effect and those initiated during the first non-mandatory phase of its application.
👉 More information provided by the European Medicines Agency (EMA) can be found here. The EMA is also organising a webinar on the 20th January 2023 from 10 a.m. to 1 p.m. (program). The last day for asking questions in advance via the audience interaction tool Slido is Friday, 13th of January 2023.