News

Preparing for new EU clinical trials regulation in partnership with the HPRA

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 …

Preparing for new EU clinical trials regulation in partnership with the HPRA Read More »

Proposal for HPRA and NREC Clinical Trial Fees: Financial Year 2022

Open for submissions from 13 September 2021 Submissions close on 8 October 2021   The National Office for Research Ethics Committees (NREC) in partnership with the Health Products Regulatory Authority (HPRA) invite submissions, observations and comments on proposed clinical trial fees to be implemented in 2022.   The objective of this public consultation process is to …

Proposal for HPRA and NREC Clinical Trial Fees: Financial Year 2022 Read More »

REC reporting relationship for clinical investigations of medical devices approved prior to implementation of EU MDR

  The following is important information for Sponsors / Principal Investigators of clinical investigations of medical devices that were approved under the Council Directives 93/42/EEC and 90/385/EEC (and their transposing legislation SI 252/1994 and SI 253/1994 as amended) and were still ongoing on the date of effect (26th May 2021) of the EU Medical Device Regulation (MDR; EU No. …

REC reporting relationship for clinical investigations of medical devices approved prior to implementation of EU MDR Read More »

Pivoting in response to the pandemic: Dr Jennifer Ralph James reflects on one-year in office

Dr Jennifer Ralph James, Head of the National Office for Research Ethics Committees, reflects on one-year in office during a global health emergency, and shares the vision for the National Office going forward.   The National Office was established in March 2020 as a fundamental component of the transition to a national system of research …

Pivoting in response to the pandemic: Dr Jennifer Ralph James reflects on one-year in office Read More »

Celebrating the foundation for future progress: National Office welcomes HRB’s investment of €6M in Clinical Trial Networks

A €6-million investment by our colleagues at the Health Research Board (HRB) in Clinical Trial Networks will create new opportunities for people on the island of Ireland to contribute to cutting-edge clinical research and help advance patient care.   People with dementia, diabetes, and infectious diseases, as well as patients of paediatrics, primary care and …

Celebrating the foundation for future progress: National Office welcomes HRB’s investment of €6M in Clinical Trial Networks Read More »

Members appointed to Ireland’s first NRECs for Clinical Trials and Medical Devices

Minister for Health, Stephen Donnelly has appointed the membership of Ireland’s first National Research Ethics Committees (NRECs) in the areas of Clinical Trials of Investigational Medicinal Products (NREC-CT) and Clinical Investigations of Medical Devices (NREC-MD).   In total, 18 members have been appointed to each of the three NRECs – two in clinical trials and …

Members appointed to Ireland’s first NRECs for Clinical Trials and Medical Devices Read More »

Collaboration Project between the National Office and the HPRA

In May 2021, the National Office and the Health Products Regulatory Authority (HPRA) will launch the CTR-National Collaboration Project. This jointly run project will test and appraise the national preparedness for a new piece of legislation due to be implemented at an EU-level in early 2022.   This new legislation, known as the EU Clinical …

Collaboration Project between the National Office and the HPRA Read More »

National Office shares plans for NREC launch

The National Office for Research Ethics Committees will launch Ireland’s first National Research Ethics Committees (NRECs) in the areas of clinical trials of investigational medical products (NREC-CT) and clinical investigations of medical devices (NREC-MD) in May this year.   In the 12 months since the National Office was established, our team has been working closely …

National Office shares plans for NREC launch Read More »

Scroll to Top Skip to content