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’.
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 Serious Adverse Events
Annual Safety Reporting Requirements
Clinical Trial Regulation — National Collaboration Project
The HPRA and the National Office for Research Ethics Committees (NREC) have initiated a National Collaboration Project to prepare for the implementation of the Clinical Trials Regulation in Ireland. The National Collaboration Project will run until December 2021.
Interested sponsors are invited to participate. The main advantages for the sponsor are that they submit the HPRA and ethics committee documents to one location, the HPRA, and if the trial is approvable will receive a single national decision within the legislative timelines.
The Guide to Clinical Trials Regulation — National Collaboration Project explains the process in detail, which replaces the previous HPRA Pilot Project.
Documents must be submitted in a Part I and II dossier structure, as required by the legislation. Dossier structure folders are available, and clinical trial documents can be added to the folders under the relevant headings.
Part I dossier structure
Part II dossier structure
Substantial Modification dossier structure
Please be advised that expressions of interest are required to be received and agreed in advance of applications being submitted for consideration under the National Collaboration Project. For further information, please contact email@example.com or firstname.lastname@example.org.
Clinical trial and National Collaboration Project cut-off dates
A list of cut-off dates for submission of CT Applications are available below.
Subcommittee dates 2021
National Collaboration Project Clinical Trial Meeting Dates 2021