The EU CTR application date is finally here!

Yesterday, the long-anticipated EU Clinical Trials Regulation (CTR) became applicable. The CTR originally entered into force in 2014 but its application date has been delayed until now due to challenges encountered with the establishment of the clinical trials portal and database, known as the Clinical Trial Information System (CTIS).

In a press release confirming the CTR’s application date, the EMA described the CTIS as the “backbone” of the CTR. In our view, it is the most significant change introduced by the CTR. The CTIS will be the single-entry point through which clinical trial sponsors can enter trial data for assessment by the relevant authorities. The CTIS also aims to increase transparency and offers a publicly accessible database with information relating to trials and results.

Earlier this month the Commission, the EMA and the HMA also announced the launch of a new initiative to complement the CTR titled Accelerating Clinical Trials in the EU (ACT EU). The announcement states that the purpose of this initiative is to transform how clinical trials are initiated, designed, and run.

Every new beginning comes from some other beginning’s end. As the CTR becomes applicable in the EU, the old regime (the Clinical Trials Directive) was also repealed yesterday. However, the CTR includes transition periods relevant to clinical trial applications and ongoing trials. 

Finally, we note that the CTR will not apply in the UK and it remains to be seen whether the UK will elect to align its legislation with the CTR. In any event, the UK will not be able to benefit from the advantages of being part of the CTIS. The MHRA recently launches an eight-week public consultation on proposals to update the current UK clinical trials legislation.