On the occasion of International Clinical Trials Day, the State Institute for Drug Control (SÚKL) published an overview of clinical trial activities and developments in the Czech Republic during 2025.
Full Transition to the European Clinical Trials Framework
The transition period ended on 31 January 2025, and all clinical trials conducted in Czech Republic became subject to the European Clinical Trials Regulation.
By this date, SÚKL had completed the transfer of all clinical trials authorised under the previous legislation. From that point onward, all clinical trials conducted in the Czech Republic have been governed by the European Clinical Trials Regulation and the current version of the Act on Medicinal Products.
Clinical Trial Applications and Authorisations in 2025
During 2025, a total of 380 applications for clinical trial authorisation were submitted through the Clinical Trials Information System (CTIS), representing an increase of 20 applications compared with the previous year.
Among the submitted applications:
- 213 applications were authorised
- 131 applications were authorised with conditions
- 23 applications were withdrawn by applicants
- 2 applications were rejected
- 4 applications were lost due to sponsor deadline failures or CTIS malfunction
Characteristics of Authorised Clinical Trials
Of the authorised clinical trials:
- 15 were submitted by non-commercial entities
- 46 involved medicinal products for rare diseases
- 35 included children or were intended for the paediatric population
- 14 involved advanced therapy medicinal products, including:
- 5 clinical trials with engineered cell-based medicinal products
- 9 clinical trials with gene therapy products
- 2 involved the first administration of a new medicinal product to a human
Therapeutic Areas
The most common clinical trial indication groups were:
- Cancer: 73 trials
- Immune system diseases: 44 trials
- Cardiovascular diseases: 43 trials
- Digestive system diseases: 32 trials
Professional Awareness and Training Activities
During 2025, SÚKL continued activities aimed at increasing awareness and education in the field of clinical trials.
Activities included:
- participation in the Ethics Committee Forum
- professional seminars on clinical trial monitoring
- seminars on the updated Good Clinical Practice Guideline
- lectures for academics and study team members
- lectures for students of pharmaceutical faculties
- training within the pharmacists’ course
- educational activities for sponsors and contract research organisations
- participation in Good Clinical Practice courses for investigators
- educational activities for patient organisations through the EUPATI programme
SÚKL also provided consultations on clinical trial evaluation matters.
In 2025, a total of 16 expert consultations were conducted:
- 9 for pharmaceutical companies
- 7 for non-commercial entities, including academics, researchers, and healthcare provider representatives
Regulatory Simplifications
During the year, SÚKL introduced several measures aimed at simplifying clinical trial processes.
Gene Therapy Clinical Trials
Requirements related to pharmaceutical preparation of gene therapy products before administration were relaxed through amendments to the Decree on Good Pharmacy Practice.
GMO Clinical Trials
For clinical trials involving genetically modified organisms (GMOs), applicants are no longer required to submit Ministry of the Environment approval simultaneously with the clinical trial application.
Sponsors are only required to obtain the GMO permit before the start of the clinical trial in the Czech Republic.
Ethics Committee Capacity
SÚKL expanded its ethics committee by adding two oncology assessors to support faster assessment of clinical trials involving first-in-human administration of medicinal products in oncology.
Activities at the European Level
SÚKL continued participation in working groups under the Heads of Medicines Agencies (HMA) and the European Commission.
Topics discussed included:
- declining numbers of clinical trial applications across the European Union
- improving the attractiveness of the European Union for clinical trial sponsors
- harmonisation of clinical trial assessment across the EU and EEA
- opportunities to shorten application assessment timelines
Participation in European Projects
FAST-EU Pilot Project
In 2025, SÚKL participated in the FAST-EU pilot project established by HMA, the Clinical Trials Coordination Group (CTCG), and MedEthics.
The project focuses on accelerated assessment of FAST-EU clinical trial authorisation applications.
According to SÚKL:
- it participated in all procedures for which it was approached
- it acted as the Reference State in one procedure
- 2 applications were authorised
- 5 procedures remained ongoing
- 1 additional application was expected to be submitted before the end of May
EU4Health Projects
SÚKL also joined two new EU4Health projects:
Project HS-g-25-27
Supports implementation of the Clinical Trials Regulation and improvement of the clinical trial environment across EU Member States and EEA countries.
Project HS-g-25-28
Supports and facilitates non-commercial clinical trials, including academic studies, and provides support for organisations conducting such research.
International Clinical Trials Day
International Clinical Trials Day is observed on May 20 and commemorates the start of the first controlled clinical trial conducted by British physician James Lind in 1747.
The trial investigated treatments for scurvy among sailors and is recognised as a milestone in the development of modern clinical research.
The annual observance highlights the contribution of clinical research to the development of safe and effective medicines.
For more information: The State Institute for Drug Control publishes data and activities in the field of clinical trials for 2025
Supporting Clinical Research Activities
As clinical trial requirements continue to evolve across Europe, effective management of clinical research activities remains essential throughout the study lifecycle.
Baupharma’s Clinical Research services support sponsors and research organisations through a range of clinical development and trial management activities:
https://www.baupharma.com/services-categories/clinical-research/
