Simplification of BMCP circulation.
In March of this year, in our column dedicated to biomedical cell products (BMCP), we wrote about the planned changes in legislation regarding the circulation of BMCP. At the moment, the State Duma of the Russian Federation in the second and third readings has approved a law that approves circulation rules for BMCP.
The first significant change in the BMCP circulation is elimination of the legal uncertainty, which consists in the duality of the regulation of medical products that simultaneously comply with the definitions of the BMCP, and products subject to registration in accordance with the Decision of the EAEU No. 78. In this regard, after the entry into force of the new Federal Law, the articles of the Federal Law No. 180 will not apply to high-tech drugs subject to registration under the rules of the EAEU, and transplantation products.
In addition, registration of BMCP for individual use, manufactured for specific patients directly in the medical institutions in which the product was prescribed, will not be required. This provision will also apply to the so-called “academic” CAR-T preparations – T-lymphocytes modified in laboratories based on medical institutions (for more details about CAR-T therapy, see the articles in column “Biomedical cell product”).
According to the information from the explanatory note to the draft law: “<…> the requirement for accreditation of medical organizations for the right to conduct clinical trials of biomedical cell products is also excluded as unclaimed and redundant due to the need to register these products from January 1, 2021 exclusively in accordance with the Rules for which this procedure is not provided.”
These changes are being made to “provide conditions for the innovative development of Russian medicine and healthcare in the context of restrictive actions of certain countries against the Russian Federation”.
The law, if approved by the Federation Council and signed by the President, will enter into force on April 1, 2024. Certain provisions of the document will begin to apply from January 1, 2026. The text of the law states that registration certificates for BMCP issued in accordance with No. 180-FZ will be valid until the end of their validity period, but no later than the end of December 2025.
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