Strategic planning is key, with time running out for transition to CTR

A second Expert View piece from Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex.

In a recent monthly newsflash, the European Medicines Agency again pointed out how little time remains to transition ongoing clinical trials in the EU to the new framework of the Clinical Trials Regulation (CTR)1  from the Clinical Trials Directive2 . The agency recently estimated that only around 580 of the 5,000 trials to be transitioned to the CTR had done so3, which raises the possibility of a rush at the end of the transition period.

The risk is that any trial that doesn’t have approval under Regulation (EU) No 536/2014 – “the CTR” – will lose its legal basis after January 30, 2025. This time crunch will put a lot of strain on EMA technical support and member state capacities to provide adequate technical and content-related support.