HPRA announces Clinical Trials Regulation-National Collaboration Project

Ireland’s Health Products Regulatory Authority (HPRA) has launched the Clinical Trials Regulation-National Collaboration Project (CTR-NCP).

This project is a collaboration between the HPRA and the National Office for Research Ethics Committee (the National office) to prepare for the incoming European Union (EU) Clinical Trials Regulation (CTR). Since the implementation of this legislation will affect how sponsors submit clinical trial applications and how the HPRA/National Research Ethics Committees for the review of Clinical Trials of Investigational Medicinal Products (NREC-CT) review and approve clinical trials, this project is intended to provide all stakeholders with an opportunity to learn and prepare for the CTR to ensure a smooth transition. Consequently, the objectives of the project are stated to be:

  • To develop proves and procedures for the joint scientific and ethical assessment of CTAs and for the potential compilation of the Part I assessment report.
  • To evaluate and amend current processes and procedures so that an efficient system is in place in Ireland when the Regulation is implemented.

Sponsor participation in this Collaboration Project is voluntary and comes at no extra cost. The HPRA are encouraging participation so that sponsors gain a better understanding of their own processes in relation to the new procedures and timelines of the CTR. Furthermore, this Collaboration Project will only be active until the date of implementation of the CTR, and its sole purpose is to prepare all stakeholders for the impending regulation.

It is important to note that there are key differences between the CTR and this Collaboration Project. Many of these will result from the fact that the Clinical Trials Information System (CTIS), which will form an integral part of the CTR, has not yet been set up and as such is not available for use in this Collaboration Project. In addition, the project still has to abide by current legislation which will impact timelines and the preparation of certain individual documents.

An extensive guidance document has been released by the HPRA, detailing all key differences as well as providing information on the scope of and how to participate in this project.