Work

The Regulatory Regime of Three-dimensional Bioprinting Products in the Legal Realities of the Republic of Belarus

Year: 2025

Type: article

Abstract: The article defines the regulatory regime of three-dimensional bioprinting products (bioprinting), namely the possibility of applying the legal regime of a drug, medical device, biomedical cellular product, the concept of sui generis special legal regime. The situation in the EAEU, the EU and the USA is analyzed with regard to the current norms that allow simultaneously qualifying bioprinting products as medicines, medical devices, high-tech therapies or sui generis objects. Common standards and requirements for bioprinted products are investigated. It is concluded that it is necessary to build a unified approach to rationalize and unify the subsequent commercial circulation of bioprinted organs and tissues, and it is expedient to consider bioprinting products as sui generis products.

Source: Vestnik of Polotsk State University Part D Economic and legal sciences

DOI: 10.52928/2070-1632-2025-70-1-63-70

Authors: A. IVANKOVICH, T. SIAMIONAVA

Institutions: Belarusian State University, Euphrosyne Polotskaya State University

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

Open Access status: diamond

Funder: Belarusian Republican Foundation for Fundamental Research

Award: G2933281429