Complying with the Clinical Trials Regulation: Guidance for sponsors

HPRA guide to conducting clinical trials in Ireland

The HPRA has compiled regulatory requirements for sponsors into a guidance document. Sponsors should use this document to help them comply with requirements for topics including:

• safety reporting
• supervision
• archiving
• appeals
• good clinical practice (GCP) inspections 
  

Clinical trial fees information

Information can be found below.  There are no fees for non-commercial/academic clinical trials.

HMA resources

The HMA's Clinical Trials Coordination Group has published guidance documents and templates, such as cover letter templates for initial applications and substantial modifications. You can view and download these documents on the HMA CTCG resources page.

CTCG Guidance on Article 11 Workaround

A new workaround for Article 11 of the CTR will apply from 27 April 2026. Guidance for sponsors to apply the new process has been published by CTCG.

This process applies to clinical trials where Part I-only submissions are planned for some Member States Concerned (MSCs). Currently, if any MSC remains Part I only, sponsors cannot submit substantial modifications or add new MSCs in CTIS.

Under the new approach, clinical trial sponsors may submit Part II placeholder documents for these MSCs as part of the initial application. This will prevent CTIS issues and enable all MSCs to be included in any future substantial modifications to the trial.

Sponsors are encouraged to include all EU/EEA MSCs where the clinical trial is planned to be conducted with the initial clinical trial application.  Complete Part II documents for each member state must be submitted and authorised before the trial can start in that country.

European Commission resources

Eudralex Volume 10 contains guidance documents for sponsors. A number of documents in Volume 10 were updated to bring them in line with the CTR. Additionally, new documents were published to cover new aspects introduced by the CTR. View the resources on the Eudralex Volume 10 page. 

The ACT EU initiative aims to address problems that make it challenging for non-commercial sponsors, such as academic sponsors, to run clinical trials, especially across multiple countries. ACT EU will propose practical and harmonised solutions to help these sponsors conduct trials more easily throughout the EU. 

For more information, visit the  ACT EU website. 

How to use CTIS

The Clinical Trials Information System (CTIS) is the shared EU portal for clinical trial applications. All clinical trials carried out in the EU/EEA must be submitted to CTIS.

The EMA has created many training resources to help sponsors use CTIS which can be found on the CTIS training and support webpage.

Sponsors should pay particular attention to the following resources:

• Guidance on CTIS account and user set-up for sponsors
• Links to further supporting materials and training videos

The Sponsor FAQ answers the most common questions raised by sponsors about using CTIS. It complements the sponsor handbook and is regularly updated as new issues arise.

CTIS live training

For issues not covered by the Sponsor handbook and FAQ please visit the EMA CTIS Support webpage. The EMA regularly publishes lists of known CTIS issues and workarounds.

If you need technical assistance, you can contact the CTIS Service Desk to log a support ticket.

CTIS news and events