Clinical Trials

Before a medicinal product can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective and also that the quality of the product is sufficient.

The HPRA is responsible for the assessment of clinical trials with medicinal products conducted in Ireland. The types of trials assessed range from first-in-man studies for new compounds to studies with products which already have marketing authorisations. 

Clinical trials begin with small studies in a controlled population of volunteers or patients and, as data are gathered, expand to large scale studies in patients. These large scale studies will often investigate the new product and the currently used treatment to see how these two compare. As information is obtained, larger numbers of patients are exposed to the new product and safety data can be collected showing the safety of the product in the intended patient population. Information on the quality of the product and its non-clinical safety will have been obtained before the clinical trial programme commences.

Details of clinical trials (except Phase 1 trials) authorised for conduct in Ireland are available on the EU CT Register.  *Use the advanced search function, and filter for ‘Ireland’. 

Our Role 

The HPRA, in tandem with the various ethics committees, is responsible for the assessment and approval of clinical trial applications in Ireland. We are responsible for monitoring the lifecycle of clinical trials in Ireland and ensuring that Good Clinical Practice (GCP) is adhered to which is vital for the continued protection of the health and safety of Irish patients.  

The HPRA readily provides guidance to industry and academia regarding potential clinical trial submissions, through pre-submission meetings and via email, and through various guidance documents and templates.

Furthermore, the HPRA is an active contributor to a number of European committees in this area such as the Clinical Trial Facilitation Group (CTFG), allowing us to provide a voice for Irish patients at European level. 

The HPRA has provided information for our stakeholders throughout the Clinical Trials section of our website. Please click on the links below for more information.

Clinical Trial Regulation (Regulation (EU) No 536/2014)

Clinical Trials Applications

Good Clinical Practice (GCP) Inspections

Reporting Suspected Unexpected Serious Adverse Reactions (SUSARs)

Annual Safety Reporting Requirements

Clinical Trial Regulation — National Collaboration Project

In preparation for the introduction of the Clinical Trial Regulation (CTR), on 31 January 2022, the HPRA and the National Office for Research Ethics Committees (NREC) initiated a National Collaboration Project to provide both organisations, as well as participating sponsors, with the opportunity to test some of the key features of the impending CTR. These features included a single submission point for clinical trial applications in addition to a single national decision within the legislative timelines.

As the national collaboration project has now concluded, the HPRA would like to extend its sincere thanks to both the NREC and participating sponsor organisations for their interactions with this worthwhile project which has helped to inform national preparations ahead of the implementation of the Regulation. 

Clinical trial cut-off dates

A list of cut-off dates for submission of CT Applications are available below.

Clinical Trial Meeting Dates for 2022 and 2023