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).
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:
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 information on how clinical trials are conducted and managed during the COVID-19 pandemic.
Find full contact details for queries relating to assessment of applications, pre-submission queries and scientific advice, and compliance and GCP topics.