News Category: Regulatory news
Regulation (EU) No 536/2014, known as the Clinical Trial Regulation (CTR), comes into effect in the European Union today, 31 January 2022. The new Clinical Trials Information System (CTIS), a new central EU portal and database for clinical trial information that forms the backbone of the CTR, also goes live today.
The CTR represents a significant change in the way clinical trials are conducted in Europe, aiming to support innovation and product development for patients, strengthen standards of safety in clinical trials and increase transparency of clinical trial information.
The CTR harmonises the submission, assessment and supervision of clinical trials in the EU. In the past, sponsors had to submit clinical trial applications separately to regulatory authorities and ethics committees in each country to gain approval to run a clinical trial, and registration and posting of results were also separate processes. Sponsors can now use CTIS to apply for authorisations in up to 30 EU/EEA countries at the same time.
Information on the authorisation, conduct and results of each clinical trial carried out in the EU will be made publicly available. This will increase the efficiency and transparency of all trials in Europe, aiming to foster innovation and research, while helping to avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials. The wider exchange of information is intended to broaden knowledge about new medical treatments, benefitting scientific research and public health. A publicly available website will allow patients to access information about ongoing clinical trials in Europe.
Additionally, the streamlined process brought about by the CTR will strengthen Europe’s position as an attractive location for global clinical research.
HPRA role in implementing the CTR in Ireland
The application of the CTR today is a landmark development, delivered following years of collaborative work by the network of European agencies. The HPRA has been preparing for implementation of the CTR in Ireland through engagement with the Department of Health, the National Office for Research Ethics Committees, the European Medicines Agency (EMA), and sponsors of clinical trials to ensure readiness for today’s go-live date.
NREC collaboration
The HPRA’s collaboration with the National Office and the National Research Ethics Committee (NREC) has been a key component of implementation in Ireland. The HPRA and NREC will act together to assess applications for clinical trials in Ireland. This joint approach was successfully piloted as part of the National Collaboration Project in 2021, in which both organisations delivered a ‘single national decision’ on a small number of clinical trial applications involving commercial and non-commercial sponsors in order to test readiness for the CTR.
Support for stakeholders
The HPRA has provided guidance and support to academic and commercial clinical trial sponsors preparing for implementation throughout 2021 including holding a weeklong series of webinars attended by a large number of stakeholders. Resources on the HPRA website include:
Expert panel
The HPRA is expanding its clinical expert panel in order to support the implementation of the CTR in Ireland, and to support our review of innovative medicines. The HPRA will publish a call for expressions of interest within the coming months.
Continued stakeholder engagement
The CTR now enters a three-year transition period. For one year, until 31 January 2023, clinical trial sponsors can still choose whether to submit an initial clinical trial application under the Clinical Trials Directive via the traditional submission process or under the CTR via the CTIS. From 31 January 2023, submission of initial clinical trial applications via CTIS becomes mandatory, and by 31 January 2025, all ongoing trials approved under the current Clinical Trials Directive will be governed by the new Regulation and will be required to transition to CTIS.
During this transition period, the HPRA will continue to provide support and guidance for stakeholders working towards implementation. Information will be added to guidance documents and other website resources as required. Additionally, the HPRA continues to welcome queries from stakeholders by email to ctreg@hpra.ie.