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.

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. 

Clinical Trials Regulation (CTR)

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

Clinical Trials Directive (CTD)

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

Good Clinical Trials Practice (GCP) inspections 

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

GCP inspections – topics of special interest 

Find information on specific topics relating to GCP inspections including:

• serious breach reporting

• informed consent

• electronic health records (eHRs)

Safety reporting in clinical trials

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

 Publication of clinical trial information 

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

Contact information for clinical trial queries  

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