Regenerative Medicine and Advanced Therapy Medicinal Products in Ukraine: Research, Regulation, and Challenges in a Time of War
摘要
Regenerative biology stands at the forefront of biomedical research, driven by advancements in cell biology, biochemistry, materials science, 3D printing, and other cutting-edge technologies. The field’s interdisciplinary nature supports its rapid translation into practical applications. However, the successful integration of scientific breakthroughs into medical practice depends on several key factors, including human capital, scientific infrastructure, innovation climate, legislative frameworks, and ethical regulations governing the application of scientific progress in medicine. In this chapter, we focus on general trends and advances in regenerative biology using cell and tissue technologies, while also outlining the main categories of regenerative biology products. We examine relevant biotechnological and legal norms, comparing existing legislation in Ukraine with European practices and the experiences of neighboring countries. Furthermore, we analyze Ukraine’s human potential and scientific infrastructure, which are essential for developing new technologies and methods and for implementing widely known cell- and tissue-based regenerative therapies and their eventual integration into clinical practice. Ukraine’s experience reflects not only the common challenges faced by developing countries (and the Global South) but also the complex difficulties resulting from ongoing Russian aggression.