Deadlines for transition to the Clinical Trials Regulation
- New/initial applications under the Clinical Trials Directive (CTD) are no longer accepted by the HPRA, and must be submitted under the Clinical Trials Regulation (CTR) using the Clinical Trials Information System (CTIS).
- 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 Clinical Trials Directive
You can find information on making an application in the Guide to Clinical Trial Applications.
Clinical trials with academic sponsors
The HPRA does not charge a fee for clinical trials conducted by academic sponsors submitted under the Clinical Trials Directive where there is no financial support for the conduct of the trial. Any request for a fee waiver should be clearly stated in the cover letter.
A protocol template is available for academic sponsors on request to firstname.lastname@example.org.