THE REGULATORY REGIME OF THREE-DIMENSIONAL BIOPRINTING PRODUCTS IN THE LEGAL REALITIES OF THE REPUBLIC OF BELARUS
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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.
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References
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