How to apply: Clinical Trial Regulation
As of 31 January 2023, applications for new clinical trials that come under the Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use (Clinical Trial Regulation or CTR) are no longer submitted directly to the National Research Ethics Committee for Clinical Trials (NREC-CT) or to the Health Products Regulatory Authority (HPRA). Instead, they must be submitted using the Clinical Trial Information System (CTIS).
- An overview of the CTR and CTIS is available here.
- An overview of Part II National Requirements and relevant documentation can be found here.
- A selection of frequently asked questions on the CTR and CTIS is available here.
Accessibility of documentation
Any documentation submitted for NREC review must be presented in an accessible and searchable format (Word or original PDF). We are unable to accept scanned documents as these documents are composed of images, rather than searchable text, and cannot be optimised for use with assistive software. If it’s not possible to submit an accessible document due to a scanned wet ink signature, an unsigned accessible version must also be included as part of the submission. Submissions that are not in an accessible format may be deemed invalid or may delay the assessment process.
NREC-CT operational framework under the CTR
In line with the CTR, the National Office and the NREC-CT have adapted their processes and requirements to meet the legislative changes. Please download the Appendix below for further information.
Part II dossier templates
The National Office has adapted templates developed and endorsed by the EU Clinical Trials Expert Group to comply with the CTR. Completion and submission of the EMA or NREC (below) templates are a mandatory requirement for any Part II dossier submission where Ireland is a Member State concerned.
Please note that the Site Suitability Form must be the NREC template, where EMA or NREC templates are accepted for the remainder of the Dossier.
Fee payment
In line with the CTR, there will be one single national fee payment applicable for all clinical trial applications and substantial modifications. This payment will be managed by the HPRA. Please see the links below for further information: