Skip to Content

Contact information for clinical trial queries

Assessment of applications:

Scientific assessment of applications:

clinicaltrials@hpra.ie / ctreg@hpra.ie

Ethical assessment of applications:

clinicaltrials@nrec.ie

Pre-submission advice or scientific advice:

National advice:

clinicaltrials@hpra.ie / ctreg@hpra.ie

Advice is available free of charge for non-commercial/academic sponsors.  Please contact us in advance of submitting a clinical trial to CTIS. 

To request scientific advice from multiple competent authorities at the same time, apply through the

Simultaneous National Scientific Advice Pilot (SNSA).

For scientific advice on early-stage development of innovative medicines for clinical trials (Phase I/II) from more than one national competent authority at the same time.

SNSA queries:

SNSA@pei.de or innovationoffice@hpra.ie

Coordinated Pre-CTA advice is also available via the CTCG Pre-CTA advice pilot for regulatory and technical aspects of clinical trials: 

Guidance for applicants Pre-CTA advice pilot_finalOpens in new window

Non-commercial/academic sponsors – request for HPRA protocol template:

clinicaltrials@hpra.ie

Compliance and GCP (Good Clinical Practice):

compliance@hpra.ie

Medical devices to be used in clinical trials:

devices@hpra.ie

Clinical trials using medicinal products containing genetically-modified organisms

Environmental Protection Agency webpage:

Notification requirements for human medicinal products | Environmental Protection Agency (epa.ie)Opens in new window