COVID-19 Related Human Research – Expedited Regulatory Review

Expedited review

The HPRA will provide an expedited review process for human health research (clinical trials of human medicines or clinical investigations of medical devices) related to COVID-19.

Submitting applications

Applications for clinical trials or clinical investigations should be marked ‘COVID-19’ and this should be included in the research title. 

Please copy the HPRA clinical trials (clinicaltrials@hpra.ie) or medical devices (devices@hpra.ie) mailbox when making an application. Please also contact us as early as possible in advance of the submission to ensure that we can prioritise the application.

HPRA contacts

Clinical trials should be submitted through the usual CESP route and copied to submissions@hpra.ie

For further information, see our guide to Clinical Trial Applications.

For information on clinical investigations of medical devices, please visit our Clinical Investigations webpage.

For further information on the HPRA response to COVID-19, see our dedicated COVID-19 webpage.

Ethical review

Applications for ethical review should be submitted to an ethics committee recognised by the Department of Health. The COVID-19 NREC is currently closed to applications.