Clinical Research and Regulatory Landscape
ATMP clinical trials are complex and require specialised skills, expertise and infrastructure. Ireland is focused on building its clinical research ecosystem in which to conduct ATMP trials. This section of the Advanced Therapeutics Ireland portal summarises the state-funded infrastructures and supports available to companies and institutes considering conducting ATMP-related clinical trial activity in Ireland.
This section of the Advanced Therapeutics Ireland portal also summarises the work of Ireland’s medicines regulatory agency, the Health Products Regulatory Agency (HPRA), and provides contact details for the HPRA’s Innovation Office.
HRB National Clinical Trials Office
HRB-NCTO is the central point of contact for the national feasibility service, ECRIN, and CRFManager. It provides a number of systemic strategic supports to academic and commercial partners in support of a harmonised strategic national approach and the conduct of high-quality clinical trials in Ireland.
Wellcome-HRB Clinical Research Facility, St James Hospital
Opened its facility in 2013 and is a collaboration between St. James’s Hospital and Trinity College Dublin. The facility has been funded by Wellcome and the HRB. WT-HRB-SJH provides the dedicated infrastructure, physical space, facilities and expertise to facilitate the conduct of high quality safe clinical research.
HRB Clinical Research Facility - Cork (CRFC)
HRB-CRFC (Clinical Research Facility Cork) has been in operation since 2011 and is a collaboration between Cork University Hospital, Mercy University Hospital and University College Cork.
HRB-CRFC provides the dedicated infrastructure, physical space, facilities and expertise to support high quality clinical trials.
HRB Clinical Research Facility - Galway (CRFG)
HRB-CRFG (Clinical Research Facility Galway) has been in operation and supported by HRB since 2008. It is a collaboration between Galway University Hospitals, Saolta Hospital Group, and NUI Galway. The HRB-CRFG provides the dedicated infrastructure, physical space, facilities, expertise and culture to support pre-clinical research and clinical trials.
UCD Clinical Research Centre (UCD-CRC)
UCD-CRC (Clinical Research Centre) was established in 2006 to support clinician-led research at St Vincent’s University Hospital and Mater Misericordiae University Hospital. HRB investment in 2021, combines with further investment from UCD and hospital partners to further drive clinical and translational research excellence in the region.
Children's Health Ireland (CHI-CRC)
CHI-CRC (Clinical Research Centre) is distributed across all CHI hospital sites and hosted by RCSI with investment from HRB and Children’s Health Foundation.
CHI-CRC aims to build on strong foundations and grow coordinated activity in the area of clinical trials for children. It aims to do this by increasing access to trials, improving supports for investigator-led clinical trials, and integrating trials infrastructure and capability as part of usual care.Currently Unavailable
HRB Trials Methodology Research Network
HRB-TMRN serves to strengthen the methodology and reporting of trials in health and social care in Ireland. They offer researchers support on challenging aspects of trial methodology and reporting of trials, by providing guidance to individual researchers, to CRF/Cs and other research infrastructures and to organisations. HRM-TMRN also provides training and education programs with the aim of advancing trials methodology research, research and innovation and public engagement in Ireland.
Royal College of Surgeons Ireland Clinical Research Centre (RCSI-CRC)
The RCSI Clinical Research Centre (RCSI-CRC) was established in 2000 at Beaumont Hospital (the second largest hospital in Ireland) as the first purpose-built CRC in Ireland. The objectives of RCSI-CRC is to collaborate with national clinical trial infrastructures, enhance patient access to trials and improve sponsorship and quality processes, contributing to the development of a connected national clinical trials infrastructure. Integrate with local, national, and international partners to increase RCSI-CRC’s participation in multi-center clinical trial activity, ensuring long-term growth and development.
University of Limerick Clinical Research Support Unity (CRSU)
Located at University Hospital Limerick, the Clinical Research Support Unit (CRSU) supports clinical research across the University, UL Hospitals sites and primary community care health settings. The CRSU serves as the co-ordinating unit for UL led studies, single site or multi-site. In cases where UL is part of a multi-site project but is not the lead site, the CRSU acts as the link for the lead site, to engage with industry, researchers and clinicians in UL, UL hospitals group and the mid-west community.
The Health Products Regulatory Authority (HPRA) is responsible for regulating health products across human medicines, veterinary medicines, medical devices for human use, clinical trials, blood and blood components, human tissues and cells, human organs for transplantation, controlled substance, cosmetics, and the use of animals for scientific purposes in Ireland. The HPRA are committed to excellence in health product regulation through science, collaboration and innovation.
HPRA are actively involved within European and international regulatory networks, through the participation of national experts at the European Medicines Agency (EMA) and the European Heads of Medicines Agencies (HMA). In the context of ATMPs, we are a member of the EMA’s Committee for Advanced Therapies.
For companies looking to establish a manufacturing or wholesaling presence within the Irish market, the HPRA are the national competent authority with responsibility to grant, and maintain oversight of, licences for companies who make, distribute and market medicines in Ireland.
The HPRA’s Innovation Office provides regulatory support and advice to individuals, academics, small and medium enterprises, pharmaceutical and medical device companies, and other groups who are developing innovative health products or technologies. Further information and contact details are available from the HPRA website.