If you need help to run a clinical trial in Poland, please contact us at info@sofpromed.com
Clinical trials play a vital role in advancing medical science and improving patient care.
With their potential to test new treatments, exchange scientific knowledge, and deliver high-quality data, clinical trials are crucial for the development of innovative therapies.
In recent years, Poland has emerged as one of the leading destinations for conducting clinical trials in Central and Eastern Europe.
In this article you will learn about:
Its mature and well-organized clinical trials market, combined with a harmonized medical and pharmaceutical legislation, make it an attractive choice for researchers and sponsors alike.
In this article, we will explore the landscape of clinical trials in Poland, including the regulatory process, the pharmaceutical industry, and the country’s healthcare system.
The Clinical Trials Landscape in Poland
Poland, with a population of around 40 million people, is the fifth-most populous member state of the European Union.
It boasts a well-established clinical trials market, accounting for approximately 21% of the total number of clinical trials in Central and Eastern Europe [1].
The country’s large population, coupled with specialized medical centers located around major cities, enables faster enrollment of participants in clinical trials.
Moreover, Poland has a growing number of centers dedicated solely to conducting clinical trials, demonstrating the country’s commitment to advancing medical research.
Regulatory Process for Clinical Trials in Poland
As an EU member since 2004, Poland has aligned its medical and pharmaceutical legislation with the European Union’s standards.
The regulatory process for conducting clinical trials in Poland involves obtaining approvals from the Regulatory Agency/Competent Authority (RA) and Ethics Committee (EC).
The Clinical Trial Application (CTA) must be submitted to the RA by the sponsor or its representative.
If the sponsor does not have a registered office within the European Economic Area (EEA), they must appoint an EU legal representative to act as the primary contact for the authorities.
The regulatory authorities in Poland typically take around 60 days to review and authorize the clinical trial. This timeline is similar to other EU countries.
It is important to note that both RA and EC approvals are mandatory before the trial can commence.
Pharmaceutical Industry and Clinical Trials Market in Poland
The pharmaceutical and clinical trial market in Poland is expected to experience significant growth in the coming years, driven by several factors such as increasing investment, a favorable regulatory environment, and a skilled workforce.
Here’s an overview of the expected growth trends:
Pharmaceutical Market Growth
Current Size
As of the latest data, Poland’s pharmaceutical market is one of the largest in Central and Eastern Europe, with a value estimated at around US$ 10 billion in recent years [2].
Expected Growth
The revenue in the pharmaceuticals market is anticipated to exhibit an annual growth rate (CAGR 2024-2029) of 3.64% [3].
Key Drivers
- Aging Population: The increasing prevalence of chronic diseases and an aging population are driving demand for pharmaceutical products.
- Government Initiatives: Ongoing healthcare reforms and government initiatives to support the pharmaceutical industry are contributing to market expansion.
- R&D Investments: Growing investment in research and development by both domestic and international companies is expected to drive innovation and market growth.
Clinical Trials Market Growth
Current Landscape
Poland is a leading location for clinical trials in Central/Eastern Europe, thanks to its large patient population, high-quality healthcare infrastructure, and cost-effective operations.
Expected Growth
The clinical trials market in Poland is projected to grow at over the next few years. For example, Poland’s oncology clinical trials market is projected to grow from US$73.4 Mn in 2022 to US$116.5 Mn by 2030, registering a CAGR of 5.95% during the forecast period of 2022-30 [4].
Key Drivers
- Increased Investment: Global pharmaceutical and biotech companies are increasingly investing in clinical trials in Poland due to its cost-effectiveness and high enrollment rates.
- Regulatory Environment: Poland’s regulatory framework is aligned with European Union standards, which facilitates the approval and conduct of clinical trials, attracting more international sponsors.
- Skilled Workforce: The availability of skilled medical professionals and experienced clinical research organizations (CROs) is a significant factor in the market’s growth.
Forecast: By 2027, the clinical trials market in Poland is expected to grow substantially, with the number of trials and patient enrollments increasing as the country continues to be a preferred destination for clinical research.
Healthcare System in Poland
Healthcare in Poland is delivered through a publicly funded system, with a growing private sector.
Working-age individuals contribute approximately 9% of their income to the National Health Fund (NFZ) [5], which provides compulsory insurance coverage.
Family members are automatically covered if one member has insurance.
Retirees, students, and the unemployed also have access to health insurance through various channels.
The availability of healthcare coverage ensures a broad participant base for clinical trials in Poland.
Patients from different demographics and medical backgrounds can be recruited, enhancing the diversity of trial participants and the generalizability of the results.
Conducting Clinical Trials in Poland: The Way Forward
Poland’s favorable regulatory environment, mature clinical trials market, and growing pharmaceutical industry make it an attractive destination for conducting clinical trials.
Researchers and sponsors can leverage the country’s large population, specialized medical centers, and highly qualified investigators to achieve their research objectives.
To navigate the regulatory process smoothly, it is essential to ensure compliance with the RA and EC requirements.
Timely submission of the CTA and appointment of an EU legal representative, if necessary, are critical steps in initiating a clinical trial in Poland.
Collaboration with local experts, such as contract research organizations (CROs) with a strong presence in Poland, can provide valuable support throughout the trial process.
These organizations have the necessary expertise and knowledge of the local landscape to facilitate efficient trial execution.
Conclusion
In conclusion, conducting clinical trials in Poland presents a wealth of opportunities for researchers and sponsors.
The country’s robust clinical trials market, harmonized regulatory framework, and growing pharmaceutical industry create an environment conducive to successful clinical research.
By tapping into the potential of Poland, researchers can contribute to medical advancements and improve patient care on a global scale.
If you need help to run a clinical trial in Poland, please contact us at info@sofpromed.com
References:
[1] Conducting clinical trials in five Eastern European countries (EU-EECs) with a focus on Bulgaria
[3] Statista Market Insights: Pharmaceuticals – Poland
