Medicines resulting from research and development (R&D) activities include medicinal products developed through a multi-stage process of preclinical and clinical trials conducted to demonstrate their quality, safety, and efficacy. This process is lengthy, expensive, and fraught with a high risk of failure. It is financed by both private and public funds (according to research by Claudie Wild, Ozren Sehic, Louise Schmidt, and Daniel Fabian, “Public contributions to R&D of medical innovations: A framework for analysis,” 26 publications were identified, which found that half of all approved medicines and >90% of target medicines are linked to public sector institutions or their funding), including EU funds and national innovation support programs. From a pharmaceutical law perspective, R&D medicines are subject to specific regulatory requirements at all stages of the product lifecycle, from clinical trials to marketing authorization and pharmacovigilance. In this context, the proposed changes to EU pharmaceutical regulations, concerning data standardization and information transparency, constitute part of a broader regulatory framework for the functioning of the innovative medicines market. The research and development process is as follows:
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.
We are facing changes: AI in the pharmaceutical industry is no longer a foreign concept. It means shorter trials, more accurate diagnoses, and the potential for drugs where we previously had given up hope. But let’s be honest, technology without a roadmap is risky. That’s why the EMA and FDA sat down to create a ten-page guide to “good practice.” These aren’t rigid rules, but a foundation of trust. We can encapsulate these 10 principles in three logical pillars.
Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) are twin regulations issued on the same day, aimed at regulating medical devices sold in the European Union. The MDR governs the making available on the market, placing on the market, and use of medical devices. The IVDR establishes the same framework for in vitro diagnostic medical devices, but also covers the rules for marketing these products (including complaints and adverse reactions).
Some hard numbers reveal the paradox: the EU has a highly developed research sector vs. the EU is a region with a challenging commercialization environment compared to other global leaders.
Biotechnology is one of the fastest-growing research and innovation sectors in the world today, and the European Union plays a significant role in this process. Over the past decade, the number of biotechnology researchers in the EU has nearly doubled, from approximately 42,000 in 2012 to over 81,000 in 2021, and the share of employment in this field has reached 17.2% of total R&D employment. These figures confirm that Europe has a strong scientific base and is systematically building capacity in technologies critical to health, industry, and food security.
