Clinical Trial Regulation in Ireland
- For queries relating to the scientific assessment of applications contact the HPRA by emailing: clinicaltrials@hpra.ie
- For queries relating to ethical assessment of applications, contact NREC by emailing: nationaloffice@nrec.ie
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:
- Single submission and approval of mono-national and multinational clinical trial applications through new CTIS Portal
- A single fee per Member State
- Identical rules for conducting clinical trials throughout the EU
- Increased efficiency of the approval process for clinical trials
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.