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)

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.

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.

HPRA information on clinical trials  

The webpages below provide regulatory information for sponsors of clinical trials. Please click on the link to view the page. 

Find information on implementing the CTR, including:

  • HPRA Guide to the CTR

  • EMA training and support for CTIS

  • European Commission's Questions and Answers Guide on the CTR

  • Registration of Processes Exempted under Article 61(5) of the CTR

Find information for sponsors on submitting an application for a clinical trial under the Clinical Trials Directive. 

Find information on the types of GCP inspections and how they are conducted. 

Find information on specific topics relating to GCP inspections including:

  • serious breach reporting

  • informed consent

  • electronic health records (eHRs)

Find information on submitting an annual safety template, reporting suspected unexpected serious adverse reactions (SUSARs) and requesting a protocol template from the HPRA. 

Find information about sponsors' obligation to make summaries of results of concluded trials publicly available. 

Find full contact details for queries relating to assessment of applications, pre-submission queries and scientific advice, and compliance and GCP topics.