Czech Republic

Regulatory

Under Regulation (EU) No 536/2014, clinical trials in the EU are authorized through the Clinical Trials Information System (CTIS). A sponsor submits one harmonized application via the EU-portal for all intended Member States. The dossier is split into:

• Part I (scientific and technical documentation, common to all CMS)
• Part II (national documents, including ethics requirements)

One Reporting Member State (RMS) coordinates the scientific review, which must be completed within 45 days, with parallel national (Part II) reviews. Requests for information may pause the clock. Each Member State must then issue a decision within 5 days, leading to an overall maximum of 60 days (extensions possible for complex therapies).

The CTR harmonizes approvals across the EU, integrates ethics committees into the process, and ensures transparency through the EU trial database. Since 31 January 2023, all new trials in the EU must follow this system.

Medical System in Czech Republic

Healthcare services are highly accessible in the Czech Republic. There is a rapid growth of private well-equipped health care facilities, which are frequently focused on conducting clinical trials.

The national healthcare system of the Czech Republic is regulated primarily by the Public Health Insurance Act. Participation in the public healthcare insurance system is mandatory for every person with permanent residency in the Czech Republic. The public health insurance system fully covers preventive medical examinations, diagnosis of diseases, and treatments.