Clinical Trials Directive (CTD)
New/initial applications under the Clinical Trials Directive (CTD) are no longer accepted by the HPRA or the NREC, and must be submitted under the Clinical Trials Regulation (CTR) using the Clinical Trials Information System (CTIS).
Timelines for transition to the Clinical Trials Regulation
Substantial amendments to trials authorised under the CTD are permitted until 30 January 2025. All trials authorised under the CTD must end or transition to the CTR by 30 January 2025.
Making an application for a substantial amendment to an authorised trial under the CTD
You can find information in the HPRA Guide to Clinical Trials authorised under the CTD.
Further information
- Clinical trials authorised under the CTD: Volume 10 of the Notice to Applicants
- Applications to ethics committees: National Office for Research Ethics Committees
- How to pay fees to the HPRA (non-commercial/academic applications are free of charge): Payment of fees instructions