January 2023: Ireland regulatory update

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