The draft law "On biomedical cell products" has been submitted to the State Duma
On the introduction of a bill to the State Duma
about biomedical cell products
Russian Government WebsiteOrder No. 160-r dated February 5, 2015.
The draft federal law "On Biomedical Cell Products" (hereinafter referred to as the bill) was developed by the Ministry of Health in pursuance of the action plan (roadmap) "Development of Biotechnologies and Genetic Engineering" (approved by Government Decree No. 1247–r of July 18, 2013), instructions of the President and the Government of Russia.
The draft law regulates relations arising in connection with the development of biomedical cell products (hereinafter referred to as the cell product), their preclinical research, examination, state registration, clinical research, production, storage, disposal, transportation, sale, importation into Russia and export from Russia.
The bill introduces an updated terminological apparatus, including such basic concepts as "biological material", "cell line", "developer of biomedical cell product", "donation of biological material", "autologous biomedical cell product", "allogeneic biomedical cell product".
The subjects of circulation of cellular products (individuals, including individual entrepreneurs, and legal entities engaged in the circulation of cellular products), their rights and obligations in the field of circulation of cellular products are also determined.
In addition, the principles of state control (supervision) in the field of circulation of cellular products are established, including licensing control in the field of production of cellular products and federal state supervision in the field of circulation of cellular products.
The draft law also establishes the powers of an expert institution to conduct examinations of a cellular product and the requirements imposed on experts during the examination of cellular products, their rights and obligations.
In addition, the procedure for submitting documents by the developer of a cellular product to the authorized federal executive authority for state registration of a cellular product, as well as the procedure and amount of payment of the state fee when performing state registration of cellular products are established.
The draft law defines the conditions and procedure for obtaining biological material from a donor for the production of a cellular product, introduces norms that allow the production and use in medical activities of personalized (autologous) cellular products containing the patient's own cells.
The draft law gives the Ministry of Health of the Russian Federation, in particular, the authority to approve the rules for preclinical research of cellular products, state registration of cellular products, approval of the procedure for monitoring the safety of the use of cellular products, licensing of the production of cellular products.
The draft law was reviewed and approved at a meeting of the Government of the Russian Federation on January 29, 2015.
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