Irish Regulations & Ethical Approvals

Clinical Trial Regulation in Ireland

Clinical trials of human medicines to be conducted in Ireland are required to be authorised by the Health Products Regulatory Authority (HPRA) and the National Office for Research Ethics Committees (NREC).

Clinical Trials Regulation (CTR)

The Clinical Trials Information System (CTIS) is an European Union (EU)-wide submission portal and database, hosted by the European Medicines Agency (EMA) and designed to support the application of the CTR.

Key features of the new CTR include:

For queries relating to the CTR click on this link Clinical Trials Regulation (CTR).

Key Regulatory Information

Submitting an Application

For a clinical trial under the Clinical Trials Directive.

For queries relating to applications for a clinical trial under the CTR click on this link clinical trials directive and GCP inspections.

Good Clinical Practice (GCP) Inspections

For queries relating to different types of GCP inspections and how they are conducted, click this link GCP inspections.

Submitting an Annual Safety Report

Including reporting suspected unexpected serious adverse reactions (SUSARs) and requesting a protocol template from the HPRA.

For queries relating to submitting an annual safety template, reporting adverse reactions and requesting a protocol template from the HPRA click this link.

Assessment of Applications

For queries relating to assessment of applications, pre-submission queries and scientific advice, and compliance and GCP topics click this link.

Key Regulatory Information

Submitting an Application

For a clinical trial under the Clinical Trials Directive.

For queries relating to applications for a clinical trial under the CTR click on this link clinical trials directive and GCP inspections.

GCP Inspections

For queries relating to different types of GCP inspections and how they are conducted, click this link GCP inspections.

Submitting an Annual Safety Template

Including reporting suspected unexpected serious adverse reactions (SUSARs) and requesting a protocol template from the HPRA.

For queries relating to submitting an annual safety template, reporting adverse reactions and requesting a protocol template from the HPRA click this link.

Assessment of Applications

Including pre-submission queries and scientific advice, and compliance and GCP topics.

For queries relating to assessment of applications, pre-submission queries and scientific advice, and compliance and GCP topics click this link.

Network Partners