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Question 8 of 20 Fundamentals Concept

How is a clinical trial authorized in the EU under the Clinical Trials Regulation?

Short answer

The sponsor submits one application through the Clinical Trials Information System (CTIS). A reporting Member State validates it and leads assessment of Part I, the scientific and product aspects, while each Member State assesses Part II, its national and ethical aspects. Each Member State then issues one single decision.

Why

Regulation (EU) No 536/2014 has applied since 31 January 2022, and since 31 January 2023 all new applications go through CTIS. The sponsor proposes a reporting Member State. That state validates the dossier within 10 days of submission.

Part I covers the benefit and risk, the protocol, the investigational product and the investigator's brochure, and the reporting Member State issues the final Part I report within 45 days of validation, after a coordinated review with the other Member States. Part II, also within 45 days, covers consent, recruitment, payment of participants, data protection, site suitability, insurance and biological samples, and each state assesses it for its own territory. Ethics committees take part according to national law.

Each Member State then notifies its decision within 5 days of the reporting date. Requests for information stop the clock, and timelines can be extended for advanced therapies. Under this system, a trial in five countries needs one dossier rather than five separate applications to regulators and ethics committees.

A strong answer covers

  • Single application through CTIS
  • Reporting Member State and coordinated Part I assessment
  • Part II assessed nationally, including ethics
  • Validation 10 days, assessment 45 days, decision 5 days
  • Applies since 2022, CTIS mandatory for new applications since 2023

Common mistakes

  • Describing separate national applications as the current EU process.
  • Assuming one Member State's decision binds all the others.
  • Forgetting that clock stops for requests for information extend the real timeline.