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 30 October 2024 at the latest to permit review and authorisation.

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

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.