The Czech Republic is cementing its position as a leading destination for clinical research in Central Europe, even as European countries face mounting pressure from Asian rivals competing for pharmaceutical investment.
The State Institute for Drug Control (SÚKL), the country’s medicines regulator, reported a strong year for clinical activity in 2025, driven by the full implementation of the EU Clinical Trials Regulation and an expansion in advanced therapies, including gene and cell treatments.
“Last year represented a fundamental turning point for clinical trials in the Czech Republic,” said Tomáš Boráň, SÚKL’s director, presenting the annual data.
“We have fulfilled all legislative requirements and created a stable and transparent environment for clinical drug research,” he added. According to Boráň, Czechia remains “a respected partner in the European area”, and the regulator aims to further strengthen the country’s attractiveness for clinical trial sponsors while maintaining high standards of patient protection and data quality.
SÚKL, which oversees the safety, quality and efficacy of medicines and supervises clinical trials in the Czech Republic, said 380 applications for clinical trials were submitted through the EU’s Clinical Trials Information System (CTIS) in 2025. The regulator approved or conditionally approved the vast majority of applications, including 14 studies involving advanced therapy medicinal products (ATMPs), among them gene and cell therapies.
EU’s falling share of global clinical trials
The figures underline the Czech Republic’s growing role in clinical development at a time when European policymakers are increasingly concerned about the continent’s declining share of global research activity.
According to data presented by the Association of Innovative Pharmaceutical Industry (AIFP), Europe’s share of global clinical trials fell from 22% in 2013 to 12% in 2023, equivalent to around 60,000 fewer clinical-trial places for European patients. The trend is particularly significant in advanced therapies, where countries compete to attract highly specialised research programmes and infrastructure investments.
“The Czech Republic is still a very good place for clinical trials. But the competition is not sleeping,” said David Kolář, executive director of AIFP. “Global competition is growing dramatically. Asian countries today can offer faster processes, lower administrative burdens and significantly stronger support for research,” he added.
Industry’s data support the regulator’s positive findings. AIFP member companies conducted 486 clinical trials in 2025, involving approximately 17,500 patients and more than 2,300 research teams across the country. Total investment reached nearly €120 million (CZK 3 billion), the highest level recorded in the monitoring period. Oncology remained the dominant research area, accounting for almost half of all ongoing studies.
“Those are figures that have a real impact – on patients, healthcare institutions and the Czech economy,” Kolář said.
Simplified requirements for gene therapies
Seeking to improve the country’s competitiveness, SÚKL has moved to reduce regulatory bottlenecks for innovative therapies. In 2025, the regulator simplified requirements for gene therapy trials, eased pharmacy preparation rules for advanced treatments and streamlined authorisation procedures for studies involving genetically modified organisms.
It also strengthened its ethics review capacity in oncology, adding two specialist assessors to help speed up evaluations of first-in-human cancer trials.
Yet challenges remain. According to AIFP, recent feasibility assessments showed that while legislative changes are progressing, many hospital pharmacies still lack the infrastructure needed for gene therapy preparation and administration. The industry argues that attracting more advanced therapy trials will require not only efficient regulation but also investments in specialised centres, logistics, workforce training and real-world evidence infrastructure.
Economic benefits
For patients, clinical trials are increasingly viewed as an important route to accessing innovative treatments before they become commercially available. According to AIFP, studies can provide access to cutting-edge therapies years ahead of routine market availability while simultaneously generating evidence needed for regulatory approval and reimbursement decisions.
The economic benefits are also significant. AIFP estimates that sponsor-funded clinical trials saved the Czech healthcare system approximately €84–88 million in 2025 by covering treatments that would otherwise have been financed through public health insurance.
[VA, BM]
Source:
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