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Clinical trials

The HPRA provides information on this section of the website on the regulation of clinical trials. Please visit the webpages listed below for more information.

Contact points for queries

Clinical trials of human medicines to be conducted in Ireland are required to be authorised by the HPRA and the National Office for Research Ethics Committees (NREC).

For queries related to scientific assessment of applications. contact the HPRA by emailing: clinicaltrials@hpra.ie.
For queries related to ethical assessment of applications, contact the National Research Ethics Committees for Clinical Trials by emailing nationaloffice@nrec.ie.
For more contact details, see Clinical trials queries.

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.

The HPRA recommends that sponsors submit transitions by 16 October 2024 at the latest to permit review and authorisation.

Sponsors can use the guidance available to assist with the transition.

The European Commission have published a guidance document for the transition of clinical trials under EudraLex volume 10.
The Clinical Trials Coordination Group (CTCG) adopted a best practice guide for multinational sponsors of transitional trials.
Training materials available on the EMA CTIS website under the Transitioning Trials section.

Non-commercial clinical trial fees

As of 1 January 2024, non-commercial sponsors are no longer required to pay clinical trial application fees in Ireland.

The definition of a non-commercial clinical trial is based on the status of the sponsor which is defined in national law (S.I. No. 99/2022).

A ‘non-commercial sponsor’ means a sponsor who has no commercial or financial interest in the outcome of the clinical trial.
A ‘non-commercial clinical trial’ means a clinical trial conducted by a non-commercial sponsor which fulfils the following characteristics.

The ownership of the investigation data belongs to the non-commercial sponsor from the inception of the clinical trial.
The design, conduct, recruitment, recording of data and reporting of the results of the investigation remain under the control of the non-commercial sponsor.

This change is intended to support and facilitate non-commercial research in Ireland.

Details on all application fees can be found in the guide to fees for human products. Applicants should note there is no fee code for non-commercial clinical trials.