Publication date: March 11, 2026
Clinical trials in Poland – status as of 2025
Clinical trials in Poland have developed significantly over the past 30 years. In 2024, Poland ranked 9th in the global commercial clinical trials market, translating into a 2.68% market share. These high results have allowed Poland to create approximately 9,400 jobs and provide 26,800 patients with access to innovative and cutting-edge experimental therapies. The medical research industry in Poland is growing rapidly, making it an attractive investment destination. According to the report, the world’s largest industry sponsors are the dominant sponsors in Poland. They account for 43% of all active industry-run research centers worldwide and 47% of active centers in Poland. This demonstrates Poland’s strong integration with global clinical trial networks. It is important to note that Poland’s growth in the clinical trials sector occurred after the challenging pandemic years. Due to the epidemiological threat and mobility restrictions imposed by the pandemic, the development of commercial clinical trials has been hampered. These were replaced by research on the SARS-COV-2 disease, as there was an urgent need to study the new disease and develop a treatment due to the global COVID-19 pandemic. Despite the pandemic and the increased attention focused on researching the new virus, Poland has not completely abandoned the development of clinical trials, as evidenced by the Polish Clinical Trials Network.
The Polish Clinical Research Network was established in March 2021 to standardize systemic quality and process solutions for entities conducting and implementing clinical trials in Poland. Its goal is also to develop Clinical Research Support Centers, which were established to standardize the implementation of commercial and non-commercial clinical trials in Poland. As a result, the Clinical Research Support Centers (CWBKs) are expected to increase the number of clinical trials in Poland and thus expand the range of modern therapies available to patients. CWBKs are staffed by professionals who assist at all stages of conducting and managing clinical trials, providing tools that can help facilitate the implementation of clinical trials. CWKB focuses primarily on ensuring that trials are conducted to the highest possible quality and in the safest possible conditions for patients. The number of CWKBs is steadily increasing, meaning more and more facilities are investing in the development of clinical trials. The Polish Clinical Research Network standardizes clinical trial standards to encourage sponsors to conduct them at public centers such as CWBKs.
Polish clinical trials are regulated by the Act on Clinical Trials of Medicinal Products for Human Use of March 9, 2023. This act primarily governs the procedure for issuing permits for clinical trials of products intended for human use, specifies the procedure for entering and deleting individuals from the list of bioethics committees (ethics committees are independent teams of experts, usually multidisciplinary, that assess whether planned trials are legal, ethical, and safe), establishes the Clinical Trials Compensation Fund, which operates under the Patient Rights Ombudsman, and introduces protections for clinical trial participants.
The Supreme Medical Council is calling for an amendment to the Act on Clinical Trials for Medicinal Products for Human Use. This is due to the growing number of clinical trials conducted in Poland. The Supreme Medical Council (NRL) calls for an increased role for independent bioethics committees to ensure high-quality substantive and ethical evaluation of clinical trials. The Medical Council also notes that medical chambers currently bear the full burden of funding and proposes that the committees be financed from fees paid for clinical trial authorization applications. The Supreme Medical Council is also calling for physicians to constitute a larger percentage of the review panel. Currently, this number is limited to one representative of a scientific discipline: medicine, pharmacy, or health sciences. The NRL wants to increase the scope of substantive discussion and thus raise the team’s standards by changing the composition of the review panel to include at least three physicians.
The President of the Medical Research Agency has published the Clinical Trials Development Plan for 2020–2030. This document contains strategic goals and tools that must be used to enable the development of clinical trials in Poland.
In the area of clinical research, the goal is to develop and improve the quality of clinical trials and research experiments. According to the report, clinical trials are a key element in the development of modern medicine due to access to modern and innovative therapies (and thus, increasing the quality and accessibility of the healthcare system for patients). This goal is to be achieved through the development of commercial and non-commercial clinical trials – that is, through the organization of competitions for the financing of commercial and non-commercial clinical trials that take into account patient needs, consider health priorities, and directly compare medical technologies. Another tool that will help achieve the aforementioned goal by 2030 is the development of medicine by supporting research experiment projects in competitions that involve, among other things, the development of new diagnostic protocols or interventional treatment methods. Among the projects underway are: comparing various surgical techniques, developing principles for an optimal care model, assessing the effectiveness of non-drug interventions administered to patients, and developing a diagnostic algorithm based on the collected data. The application of these methods is expected to result in, among other things, The report includes the development of new treatment methods using commercially available medicinal products and medical devices, the optimization of modern treatment, the development of the pharmaceutical and biotechnology industries, and increased patient access to specialized healthcare. The report mentions support from Polish legislators in developing the clinical research sector in Poland. These efforts are expected to align Polish legislation with European clinical research standards. The document also envisages the training of clinical research staff to enhance their competencies. To achieve this, training courses and conferences are planned, as well as cooperation in opening new postgraduate programs. The report also focuses on the development of commercial and non-commercial clinical research infrastructure in Poland.
The report shows that the development of clinical trials in Poland is planned comprehensively – from drafting legal amendments, through developing new treatment methods, to optimizing and modernizing current medical methods for treating patients. Poland is primarily an attractive location for pharmaceutical companies, who see it as a potential sponsorship opportunity. This sector faces various challenges, but this has not hindered its rapid and innovative development.