How to legally conduct a clinical trial in the Czech Republic

What is a clinical study from a legal perspective

From a legal perspective, this means that state authorities, primarily the State Institute for Drug Control – SÚKL in the Czech Republic and the relevant ethics committee, must verify the safety of the study and the protection of patients' rights at every step. The lawyers at ARROWS law firm have been specialising in the regulatory field of medicinal products and clinical studies for over ten years and are familiar with the risks of the entire process.

Regulatory framework: What you need to know

In 2026, clinical studies in the Czech Republic are primarily regulated by the following legal acts:

1. Regulation (EU) No 536/2014 of the European Parliament and of the Council (CTR) – a directly applicable regulation for the entire EU. This regulation has unified the application process through the CTIS portal and introduced strict rules for transparency and subject protection. For a broader context of changes in the healthcare sector regulation for 2026, the following overview of what is changing in the regulation of supplements and medicinal products in 2026 may also be useful.

2. Act No. 378/2007 Coll., on Pharmaceuticals – the key Czech law that supplements the European regulation on matters left to the competence of Member States (e.g., specifics of the functioning of ethics committees, sanctions, language requirements).

3. Act No. 372/2011 Coll., on Health Services – regulates the conditions for the provision of health services by the providers where the study is conducted.

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

Step by step: The approval process

The first and absolutely crucial step is the registration of the sponsor in the CTIS (Clinical Trials Information System). All documentation is uploaded here, and there is no longer a "paper submission".

You must prepare extensive documentation divided into a scientific part (Study Protocol, Investigator's Brochure, documentation on the medicinal product) and a national part (Informed Consent, recruitment procedures, insurance). For the informed consent and the processing of participants' sensitive data, it is advisable to simultaneously review the data protection setup according to GDPR. In parallel, you must ensure cooperation with the relevant ethics committee in the Czech Republic, which will assess the study as part of the national part of the application.

Application submission and validation

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

Application assessment

The standard period for assessment 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 a 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 process is ongoing in CTIS, you must conclude clinical trial agreements with individual healthcare facilities (sites). Although these contracts are not subject to direct approval in CTIS, the study cannot be practically initiated without them, and this is often where the hospital's legal department gets involved.

Decision and site activation

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

Rights and obligations of study participants

In a legal sense, every participant (subject) in the study must be properly informed and must sign an Informed Consent form approved as part of the application. The document must be in Czech, understandable to a layperson, and must not contain legal loopholes that absolve the sponsor of liability.

Participation must be voluntary, without coercion or inadequate financial motivation that could influence judgment. A participant may withdraw from the study at any time without giving a reason and without penalty.

The sponsor must have liability insurance for damages 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 means not only a procedural error but also potential civil liability for compensation for harm.

Ensuring safety and transparency

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

The sponsor has an obligation to immediately report all Suspected Unexpected Serious Adverse Reactions (SUSARs) to the EudraVigilance database. Ignoring this obligation is a serious administrative offence.

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

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 and the Act on Pharmaceuticals impose specific requirements.

For minors or persons incapable of giving consent, the consent must be signed by a legal representative (parent, guardian).

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

It is precisely these rules that are very sensitive, and their violation is not only a breach of the law but also of ethical standards, which can lead to the immediate halt of the study.

International aspects and the ARROWS International network

Most modern clinical studies are multicentric and take place in several EU states. Thanks to the CTIS system, you submit a single application for all states, but national specifics, such as contracts, insurance, or ethics committees, remain different in each country. ARROWS law firm has a worldwide network of partners (ARROWS International), which allows for effective legal support in international clinical studies and the handling of local requirements in other jurisdictions.

Conclusion

Conducting a clinical study in the Czech Republic is a process that, although centralised thanks to digitalisation (CTIS), carries a number of legal risks and strict deadlines. Errors in document preparation, missed deadlines for responding to the regulator, or deficiencies in insurance lead to application rejection, fines, or liability for damages.

The lawyers at our Prague-based ARROWS law firm deal with this issue daily and know the CTR 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 the legal supervision of your study to experts. ARROWS law firm will help you from the very first step – from reviewing contracts and the protocol to closing the study and archiving. Just write to us at consultation@arws.cz and we will arrange a consultation.