Rene Van Melick
The article “Regulatory perspectives of combination products” discusses the complexities involved in the research, development, and regulatory evaluation of combination products, which are medical products comprising multiple components like drugs, devices, or biological products. It covers the origin, definition, and designation of these products, highlighting the regulatory challenges due to their innovative nature. The review addresses the preclinical and clinical evaluations necessary to ensure safety and efficacy, emphasizing the need for new tools and technologies such as computational modeling, artificial intelligence, and organ-on-chips. It also underscores the importance of developing new standards and evidence-based research methods to support regulatory science advancements, facilitating the efficient regulation of these complex products to improve healthcare outcomes.