Skip to content
Trial Agents

CTIS country guides

CTIS Country Hubs

All interventional clinical trials involving medicinal products in the EU/EEA must be submitted through CTIS. Part I covers the common scientific and technical assessment of the trial, while Part II covers country-specific requirements such as ethics, participant documents, sites, investigators, insurance and privacy. These country hubs bring together the relevant information to help you understand and prepare Part II for each participating country.

Never miss a regulatory update

We continuously monitor EU-level and local European regulatory announcements and turn them into practical updates for regulatory leaders.

By entering your email, you agree to receive emails from Trial Agents. You can unsubscribe anytime.