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The Clinical Trials Regulation (EU) No 536/2014 becomes mandatory for all initial clinical trial applications

Calendar marking the date of the 31st of January 2023 when Regulation (EU) No 536/2014 will be mandatory for all initial clinical trial applications

January 12, 2023

End of the first transition period for the new Clinical Trials Regulation

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.