Aim: To develop a scientifically grounded approach to defining the basis and limits of criminalizing fraud and misconduct in clinical trials of medicinal products, while also raising awareness and encouraging serious discussion of these issues. Materials and Methods: The study relies on the Acquis Communautaire and the legislation of Ukraine, Germany, and Poland. It also uses judicial practices from the United States, France, and Ukraine, as well as legal statistics and draft legislation from Ukraine. Scientific research methods such as induction, deduction, comparison, analysis, case studies, and systems analysis were employed. Conclusions: Criminal penalties for unlawful actions during clinical trials of medicinal products, guided by the ultima ratio principle, should be applied only to violations that threaten the lives or health of research subjects, infringe upon their rights, or involve falsification of clinical trial results regarding the effica and safety of the products, rather than to any violations alone