In this video, Minister Stephen Donnelly reflects on why the introduction of new EU clinical trial regulation marks an important milestone in the advancement of Irish health research, and pays tribute to the pivotal role of the National Office for Research Ethics Committees (NRECs) volunteer committee members in championing better health and care for all.
Having entered into force on 31 January 2022, the regulation brought greater regulatory convergence and efficiency to the clinical trial application process, and put a renewed emphasis on clinical trial safety and public transparency. A life-cycle approach to trial oversight supports NREC's work in strengthening clinical research standards and protecting the wellbeing of those taking part in clinical studies, while the launch of a new dedicated website provides the public with information on the safety and efficacy of clinical trials conducted across the European Economic Area (EEA).
A key feature of the regulation is the introduction of a unified, online portal for all clinical trial information across the EEA, bringing change to the way in which trial applications are submitted, and even greater harmonisation between the National Office and the Health Products Regulatory Authority (HPRA), under the auspices of the Department of Health.
Member of the clinical trial community? Learn more about the implications of the regulation and the new submission processes involved.