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.
Clinical Infrastructure and Supports for ATMPs
Ireland has a well developed clinical trials infrastructure. This supports expert clinicians with international experience to contact impactful clinical studies across the university and healthcare sectors. The expertise in ATMP trials is at an early stage but expanding apace.
Ireland is known for its outward looking, open minded and adaptable approach to technological advances as well as a skilled, productive workforce. The attributes of the people and the environment are key reasons to conduct ATMP trials in Ireland. The interactive map below showcases the current infrastructure and supports for ATMPs.
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.
Clinical Research Infrastructure and Supports
Other Clinical Research Resources
Over recent years, Ireland has built up a number of centralised services to support the development and implementation of clinical trials. These national support services include:
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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.
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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.
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National Office for Research Ethics (N-REC)
Established in 2020, the National Office is a national system of research ethics review for regulated remits, including clinical trials of medicinal products, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices.
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Clinical Trial Network
Ireland has numerous Clinical Trial Networks funded by the Health Research Boards (HRB) including Dementia, Rare Diseases, Blood Cancer, Maternal/Newborn Care, Primary Care and Cancer.
Expertise
The Cell and Gene Forum Working Group 7 is a collaborative effort by stakeholders in the Clinical and Clinical Trials sectors in Ireland. In 2021, WG7 facilitated a number of seminars. These events informed a report for the Cell and Gene Forum in 2022. An aim of this group is to establish an Irish ATMP treatment centre network.
Working Group 7
Improving Ireland’s CGT Clinical Trial ecosystem
