Bioink as a type of biologically active substances: Issues of technology and legal regulation

Abstract

3D bioprinting as a digital innovation gives hope to patients in need of organs and awaiting transplantation, as well as other patients. The prospects for bioprinting are significant; many types of bioink are being developed, without which this digital technology may not exist. However, the legal regulation of thing developing sphere of medical science is in its initial stage. Given the complexity and duration of creating legal norms for new directions in medical science, we consider it important to start developing legislative acts that will regulate 3D bioprinting and establish requirements for bioink so that they are ready by the time the first organ (tissue) constructs suitable for clinical use appear. It is emphasized that the study of technological and legal aspects of bioinks as biologically active substances is an extremely relevant and promising scientific task.