Modern areas of Biomedicine are multiple and multifaceted. These include: cellular and gene technologies, biocompatible materials, technologies for molecular genetic diagnostics, personalized medicine, organ transplantation, tissues and cells for human application. At the same time, the development of Biomedicine and the use of its achievements in humans have determined a high need for legal and ethical regulation of these processes both at the national and international level. The purpose of the work was to review and analyze international acts that define the legal and ethical aspects of Biomedicine in order to improve and harmonize national legislation in individual countries of the world. Materials and methods. To achieve this goal, the current state of the international legal framework on Biomedicine, organ donation and transplantation, tissue and cell donation and their human application studied. Results and discussion. It is necessary to approach the problems arising from the rapid development of Biomedicine in a comprehensive manner, since they unite human rights, ethical norms, scientific achievements, aspects of socio-economic development, and elements of illegal actions. Problems of improving legislation in the field of Biomedicine include such topical issues as organ donation and transplantation, tissue and cell donation and their human application. Conclusion. Active development of modern areas of Biomedicine requires constant improvement of national legislation based on global principles developed and approved at the international level.