Upcoming EU clinical trials regulation will bring change to the way in which clinical trial documentation is submitted and introduce a new one-stop submission process for applications that require approval by both the Health Products Regulatory Authority (HPRA) and the National Research Ethics Committees (NRECs).
The new Clinical Trials Regulation was first adopted by the European Medicines Agency (EMA) in 2014 and will come into effect in January 2022, impacting all European Economic Area (EEA) countries as well as companies and organisations that wish to run clinical trials in the EEA. The regulation is applicable for investigational medicinal products for human use and doesn’t apply to non-interventional trials or trials without medicinal products such as devices.
A renewed emphasis on clinical trial safety and public transparency
Implementation of the regulation will involve the roll-out of a unified portal and database for trial sponsors and regulatory agencies in EEA countries, promising to bring greater regulatory convergence and efficiency to the clinical trial application process.
A life-cycle approach to trial oversight will support the work of the National Office for Research Ethics Committees in strengthening clinical research standards and protecting the wellbeing of Irish patients taking part in clinical studies. And the launch of a new dedicated website, where members of the public can access detailed information on all clinical trials conducted in the EU will provide greater public transparency on the safety and efficacy of drugs.
One-stop portal for all clinical trial applications and what it means for ethics review
A key feature of the regulation is the launch of a new portal and database, known as the Clinical Trials Information System (CTIS), which will act as a single point of entry for clinical trial submissions, approvals and all end-to-end processes throughout the lifecycle of a trial.
Currently, sponsors must submit an application separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. The introduction of a one-stop submission process means that applications that require ethics approval by both the National Office and the HPRA can be reviewed in a single application. What’s more, through this new system, sponsors can apply for trial authorisation in up to 30 EEA countries with a single application – reducing duplication and delays, and creating a simplified and streamlined approach to clinical trial submission and assessment.
National and EU-wide collaboration
In preparation for change, the National Office and the HPRA jointly launched the National Collaboration Project in May to ensure national readiness and facilitate a cohesive national transition to the new regulation. The project will run until December with the aim of ensuring synergy for clinical trials that require approval from both the National Office and the HPRA.
As part the project, the HPRA and the National Research Ethics Committee for Clinical Trials of Investigational Medicinal Products (NREC-CT), supported by the National Office, is working closely with a small group of volunteer academic and industry sponsors who are currently conducting trials in Ireland, to help them navigate the new timelines and processes ahead of the regulation coming into effect.
At EU level, close collaboration with the CTR Implementation: Ethics Committee Knowledge Exchange Forum, made up of representatives from 22 member states is a key opportunity for the National Office team to share learnings with other European counterparts in preparation for and implementation of the regulation.
- CTIS sponsor handbook addresses key questions on CTIS, information on how to use the system, topics related to sponsor preparedness and useful links to reference materials.
- This online modular training programme offers practical guidance in preparing for the CTIS.