Launching a Clinical Trial in the Czech Republic: Key Legal Requirements

Mgr. Dita Zbožínková, LL.M.
Mgr. Dita Zbožínková, LL.M.
13.3.2026 | ARROWS law firm

Are you preparing to launch a clinical trial in the Czech Republic and unsure what legal steps lie ahead? In this article, you will find answers to key questions regarding legal requirements under Czech law, protocol approval, and dealings with regulatory authorities. A clinical trial is a complex legal process, where a mistake can be costly, so we will also focus on potential sanctions and how to avoid them.

The illustrative image shows a specialist addressing the legal requirements of a clinical trial.

Quick summary

  • Every clinical trial in the Czech Republic is subject to strict EU regulations () and Czech law; the process is handled centrally via the .
  • Key risk: non-compliance can lead to fines of up to CZK 20 million, suspension of the trial, or even criminal liability; administrative and procedural details also involve many hidden costs.
  • ARROWS, a Prague-based law firm, has long-standing experience in handling regulatory matters and routinely assists clients with preparing documentation, representation before authorities, and ensuring compliance with all legal requirements under Czech legislation.

What a clinical trial is from a legal perspective

A clinical trial, under current legislation referred to as a “clinical study” (klinické hodnocení), is not merely a scientific project; in legal terms it is a strictly regulated research activity. Under the Act on Pharmaceuticals and European standards (in particular Regulation (EU) No. 536/2014 of the European Parliament and of the Council, the so-called CTR), a clinical trial is defined as any research conducted in humans with the aim of ascertaining or verifying the clinical, pharmacological, or other pharmacodynamic effects of a medicinal product or active substance.

From a legal perspective, this means that public authorities—primarily in the Czech Republic the State Institute for Drug Control – SÚKL and the relevant ethics committee—must verify at every step the safety of the trial and compliance with patients’ rights. Attorneys at ARROWS, a Prague-based law firm, have been focusing on the regulatory area of medicinal products and clinical trials for more than ten years and understand the risks of the entire process.

Related questions on the legal definition and classification of trials

1. What is legally considered a clinical trial?
A clinical trial is defined as research involving a patient (subject) in which the effects of a medicinal product or a treatment procedure are verified. In case of doubts about classification (e.g., whether it is a clinical trial or a non-interventional study), you must proceed in line with SÚKL’s interpretation, as it is the decisive authority on this matter in the Czech Republic.

2. Do legal requirements differ depending on the type of study (without a medicinal product, non-interventional study)?
Yes, the regulatory regime differs significantly. Non-interventional (observational) studies, where the medicinal product is administered in accordance with its marketing authorisation and diagnostic procedures do not go beyond standard practice, are subject to a lighter regime (only notification to SÚKL, and ethics committee approval depending on the type of site), whereas interventional clinical trials are subject to the full authorisation process in the CTIS system.

3. Who is the “sponsor” of a trial under the law?
The sponsor is a person (natural or legal), company, institution, or organisation responsible for initiating, managing, and arranging the financing of a clinical trial. In legal terms, the sponsor bears strict (objective) liability for safety and scientific quality.

Regulatory framework: What you need to know

In 2026, clinical trials in the Czech Republic are primarily regulated by the following legislation:

  1. Regulation (EU) No. 536/2014 (CTR) – a directly applicable regulation across the EU. This regulation unified the application process via the CTIS portal and introduced strict rules on transparency and the protection of subjects.
  2. Act No. 378/2007 Coll., on Pharmaceuticals – a key Czech statute that supplements the EU regulation in areas left to Member States (e.g., specifics of how ethics committees operate, sanctions, language requirements) under Czech law.
  3. Act No. 372/2011 Coll., on Health Services – governs the conditions for the provision of health services by the providers at whose facilities the trial is conducted in the Czech Republic.

What does this mean in practice? Failure in any one of these areas means the system will reject your application or the approval process will be significantly prolonged.

Step by step: The approval process

The first and absolutely essential step is registering the sponsor in the CTIS (Clinical Trials Information System). All documentation is uploaded there, and there is no longer any “paper filing”.

You must prepare extensive documentation divided into a scientific part (trial protocol, investigator’s brochure, medicinal product documentation) and a national part (informed consent, recruitment procedures, insurance). In parallel, in the Czech Republic you must ensure cooperation with the relevant ethics committee, which will assess the trial within the national part of the application.

Submission of the application and validation

After uploading to CTIS, a 10-day period runs for validation of the application, i.e., a completeness check. If SÚKL identifies deficiencies, it will invite you to supplement the application; you have a maximum of 10–15 days depending on the type of deficiency. If you miss the deadline, the application automatically lapses.

Assessment of the application

The standard assessment period is 45 days from validation, and this period may be extended if the regulator raises questions (RFI). You usually have only 12 days to respond, which requires deep knowledge of regulatory standards and the ability to communicate with the authority accurately and quickly.

At this stage, the ethics committee assesses the ethical aspects of the research, patients’ rights, and the clarity of the informed consent. Its opinion is binding for the final decision in the Czech Republic.

Contractual arrangements and approval at the trial site

While the CTIS process is ongoing, you must enter into clinical trial agreements with the individual healthcare facilities (sites/centres). Although these agreements are not subject to direct approval in CTIS, the trial cannot be started in practice without them, and the hospital’s legal department is often involved at this stage.

Decision and site activation

Once a positive decision is issued in CTIS (including the opinion of SÚKL and the ethics committee), the trial is authorised in the Czech Republic. The sponsor must then notify the date of the start of subject recruitment in the CTIS system.

Related questions on the approval process

1. How long does the entire approval process take?
Thanks to the fixed deadlines in Regulation 536/2014, the process usually takes 60 to 106 days (including rounds of questions). The process is more predictable than in the past, but it places extreme demands on the sponsor’s response speed.

2. Can I start the trial if SÚKL agrees but the ethics committee has reservations?
No. A single decision is issued for the Czech Republic. If the ethics committee’s opinion on Part II is negative, the overall decision for the Czech Republic will be negative.

3. What is the EU CT Number?
It is the unique trial identification number generated by the CTIS system (previously the EudraCT number was used). Without this number, the trial does not legally exist.

Rights and obligations of trial participants

In legal terms, each participant (subject) in the study must be duly informed and must sign an Informed Consent approved as part of the application. The document must be in Czech, understandable to a layperson, and must not contain legal loopholes that would release the sponsor from liability under Czech law.

Participation must be voluntary, without pressure or inappropriate financial incentives that could affect judgment. The participant may withdraw from the study at any time without giving a reason and without penalties.

The sponsor must have liability insurance arranged for damage arising in connection with the clinical trial. This insurance must be valid for the entire duration of the study in the Czech Republic.

A breach of these obligations constitutes not only a procedural error, but also potential civil liability for compensation of harm under Czech legislation.

Risks and sanctions

How ARROWS helps (office@arws.cz)

Study rejection (Lapsed application): If you fail to respond to questions in CTIS within a short deadline (e.g., 12 days), the application for authorisation automatically lapses.

Preparation and deadline monitoring: ARROWS’ Czech legal team monitors procedural deadlines and helps formulate correct responses to SÚKL’s comments (the Czech State Institute for Drug Control).

Fine of up to CZK 20 million: For conducting a clinical trial without authorisation, or for a serious breach of the sponsor’s obligations, the Act on Pharmaceuticals provides for a fine of up to CZK 20,000,000.

Compliance and representation: ARROWS, a Prague-based law firm, performs compliance audits of procedures under the Act on Pharmaceuticals and represents clients in proceedings before SÚKL.

Liability for personal injury: If a study participant suffers harm to health and the sponsor does not have properly set insurance or contracts in place, there is a risk of court disputes over damages in Czech courts amounting to millions.

Contracting and insurance: We review insurance policies and prepare clinical trial agreements so that they clearly define liability relationships.

Unlawful conduct of the study: Starting the study before the formal notification in CTIS or continuing after it has been suspended is a serious offence.

Legal oversight: We ensure that all formal steps (notification of start, end, interruption) are completed in the CTIS system on time.

Study suspension by the regulator: SÚKL has the authority to immediately suspend a study for safety reasons. This brings enormous financial losses and reputational risk.

Crisis management: If a suspension is imminent, we engage with the regulator immediately and propose corrective measures.

Ensuring safety and transparency

One of the sponsor’s key obligations is to ensure that the study is monitored and that data is reported transparently. The sponsor must ensure adequate on-site monitoring of the conduct of the study, where monitors (CRAs) verify compliance with the protocol and Good Clinical Practice.

The sponsor is obliged to promptly report all suspected unexpected serious adverse reactions (SUSARs) to the EudraVigilance database. Ignoring this obligation is a serious administrative offence under Czech law.

Archiving is also important: both the sponsor and the investigator must retain documentation (the Master File) for at least 25 years after the end of the clinical trial. In practice, these are complex procedures requiring precision, which ARROWS’ attorneys address by setting up processes in contractual documentation with CROs and research sites.

Related questions on monitoring and safety

1. Who bears responsibility if the CRO fails?
Legally, responsibility for the study remains with the sponsor, even if it has delegated activities to a CRO. This is why a high-quality contract between the sponsor and the CRO is crucial, enabling recourse claims.

2. What happens if a monitor finds that a research site is breaching the protocol?
The sponsor must remedy the situation without delay. If the breach is serious and persistent, the sponsor must terminate the site’s participation in the study and inform SÚKL (the Czech State Institute for Drug Control).

3. To whom do I report serious breaches?
The sponsor must report each serious breach of the protocol or the regulation via CTIS within 7 days if it may affect subject safety or the scientific value of the data.

Special aspects: Vulnerable populations

If you are planning a study that includes so-called vulnerable subjects (for example, minors, persons with limited legal capacity, persons in emergency situations), the CTR Regulation and the Czech Act on Pharmaceuticals impose specific requirements.

For minors or persons unable to give consent, the consent must be signed by a legal representative (parent, guardian).

Minors must also receive information appropriate to their age and their opinion must be taken into account, and a minor’s dissent must be respected. Studies involving vulnerable populations must usually have a direct health benefit for the participant, or must be associated only with minimal risk and burden.

These rules are particularly sensitive, and breaching them is not only a violation of Czech law but also of ethical standards, which may lead to the immediate termination of the study.

International aspects and the ARROWS International network

Most modern clinical studies are multicentre and take place in multiple EU Member States. Thanks to CTIS, you submit one application for all countries, but national specifics—such as contracts, insurance, or ethics committees—remain different in each country. ARROWS, a Prague-based law firm, has a global network of partners (ARROWS International), enabling efficient legal support for international clinical studies and the handling of local requirements in other jurisdictions.

Conclusion of the article

Conducting a clinical trial in the Czech Republic is a process that, although centralised thanks to digitalisation (CTIS), involves a number of legal risks and strict deadlines. Errors in preparing documentation, missing deadlines to respond to the regulator, or shortcomings in insurance lead to rejection of the application, fines, or liability for damages.

The attorneys at ARROWS, a Prague-based law firm, deal with this area on a daily basis and know the CTR Regulation and the Act on Pharmaceuticals in detail.

If you do not want to risk mistakes, fines, or delays in bringing a medicinal product to market, entrust legal oversight of your study to experts. ARROWS will assist you from the first step—from reviewing contracts and the protocol through to closing the study and archiving. Simply email us at office@arws.cz and we will arrange a consultation.

FAQ – Most common legal questions on conducting a clinical trial in the Czech Republic

1. Must the sponsor be a legal entity?
The sponsor may be either a natural person or a legal entity. In the vast majority of cases, however, it is a legal entity (a pharmaceutical company, a university). If the sponsor is not established in the EU, it must appoint a so-called Legal Representative in the EU, who is responsible for compliance with the regulation.

2. When will I receive the study number?
You will receive the “EU CT Number” automatically when you create the first draft application in the CTIS system. This number will accompany the study throughout its entire lifecycle.

3. What is the amount of the fine for failing to report an adverse event?
For a breach of obligations in safety monitoring (pharmacovigilance) and failure to report serious adverse reactions, a legal entity may face a fine under the Czech Act on Medicinal Products of up to CZK 20,000,000.

4. How long do I have to retain clinical trial documentation?
Under Article 58 of Regulation (EU) No 536/2014, both the sponsor and the investigator are required to archive the contents of the Trial Master File (TMF) for at least 25 years after the end of the clinical trial.

5. Do I have to report all adverse events to SÚKL?
The sponsor reports without undue delay only so-called SUSARs (suspected unexpected serious adverse reactions) to the EudraVigilance database. Other adverse events and reactions are recorded by the investigator in the documentation, and the sponsor evaluates them in annual safety reports (ASR), which are submitted via CTIS.

6. If the application is rejected, can I file an appeal?
Yes, an appeal (rozklad) may be filed against a decision rejecting authorisation of a clinical trial (in the case of a decision by SÚKL, the Czech State Institute for Drug Control). The deadline for filing is 15 days from delivery of the decision. The Czech legal team at ARROWS, a Prague-based law firm, can assist with preparing the appeal—however, precise legal and factual arguments are key.

Disclaimer: The information contained in this article is for general informational purposes only and serves as a basic guide to the issue as of 2026. Although we strive for maximum accuracy, laws and their interpretation evolve over time. We are ARROWS Law Firm, a member of the Czech Bar Association (our supervisory authority), and for the maximum security of our clients, we are insured for professional liability with a limit of CZK 400,000,000. To verify the current wording of the regulations and their application to your specific situation, it is necessary to contact ARROWS Law Firm directly (office@arws.cz). We are not liable for any damages arising from the independent use of the information in this article without prior individual legal consultation.

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