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.
Biotechnology has been included in the European Commission’s political programme for 2024–2029 as one of the key technologies for the EU’s economy and security.
The EU Biotech Act is an EU initiative aimes at making Europe a global leader in biotechnology by simplifying regulations, increasing funding (including €10 billion for innovation), and supporting bioproduction. The legislation covers innovation in medicine, agriculture, and industry.
Prepared by Kamil Żbik, KIELTYKA GLADKOWSKI KG LEGAL
One of the characteristics of diseases and conditions is that different illnesses often affect people to completely different degrees and with completely different frequencies. With the advancement of modern medicine, organizations have begun to take a more serious look at the problem of rare diseases. However, the diagnosis and treatment of such diseases are still highly problematic. One of the problems associated with this is the low revenue from such drugs. Due to the fact that some diseases are very rare, the cost of the process of developing and introducing them to the market is disproportionate to the expected sales of such drugs. This happens because of a very narrow group of people affected by such diseases. Drugs for these rare diseases are called orphan drugs or orphan medicinal products.
