Conducting gene therapy trials involving genetically modified organisms (GMOs) and companion diagnostics (CDx) in the European Union presents one of the most complex regulatory challenges in modern clinical development. With three overlapping regulatory tracks—Clinical Trial Authorization (CTA), GMO authorization, and CDx performance studies—success requires strategic coordination, parallel submissions, and deep familiarity with evolving EU directives.

The EU Regulatory Playbook from TFS HealthScience provides clinical trial sponsors with expert insights, practical tools, and real-world examples to navigate this landscape efficiently. Building upon the foundation of the TFS-hosted webinar, this white paper acts as a comprehensive operational and strategic guide for mastering parallel regulatory submissions, selecting optimal trial countries, and minimizing delays in trial start-up.

Download our playbook to discover:

• Plan all approvals together: Gene therapy trials in the EU need three separate approvals—one for the drug, one for the GMO, and one for the diagnostic. You need to plan and manage them at the same time to avoid delays.

• Each country has different rules: Even though the EU has shared regulations, each country interprets them differently. It’s important to understand local requirements before starting your trial.

• New systems are coming online: The EU is launching new tools like EUDAMED to track devices and diagnostics. Get set up early so you’re ready when it becomes mandatory.

• Sites must be ready in advance: Trial sites need trained staff, proper safety protocols, and internal approvals before the study can begin. Preparing early keeps everything on schedule.

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