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 (medicines) conducted in Ireland. The types of trials assessed range from first-in-man studies for new compounds to studies with medicines 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 medicine 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.
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’.
New clinical trials legislation was implemented in Europe on 31 January 2022. The Clinical Trials Directive is being replaced by the Clinical Trials Regulations. Further information is provided on our dedicated webpage for the CTR.
The HPRA, in conjunction with the National Office for Research 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 provides guidance to industry and academia regarding potential clinical trial submissions, through pre-submission meetings and via email (email@example.com), and through various guidance documents and templates.
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 applications under the Clinical Trials Directive: cut-off dates valid up to 31 January 2023
A list of cut-off dates for submission of CT Applications under the Clinical Trials Directive are available below.
IMPORTANT: New/initial clinical trials applications can only be made under the Clinical Trials directive before 31 January 2023. From this date, new/initial applications must be made under the Clinical Trials Regulations, via the Clinical Trials Information System (CTIS).
Clinical Trial Meeting Dates for 2022 and 2023