Deadlines for the transition to the Clinical Trials Regulation (CTR) were recently discussed in a post by the Health Products Regulatory Authority (HPRA), Ireland.
The details are summarized below:
- Only until January 25, 2023, will HPRA and the National Office for Research Ethics Committees (NREC; [email protected]) accept new or initial applications under the Clinical Trials Directive (CTD).
- The HPRA and NREC must receive the new clinical trial application at the same time in order to validate and authorize it. The NREC website lists the deadlines for January.
- If the simultaneous application to NREC cannot be filed at the time, it is advisable to submit a new clinical trial application in compliance with the updated Clinical Trial Regulation (CTR).
- Until 30 January 2025, significant changes to trials authorized under the CTD are allowed.
- By January 30th, 2025, all trials authorized under CTD must be completed or transferred to CTR.
Further details can be found here