Clinical Study Part for BMCP was last updated on our website in 2018. This is because no special events have occurred since the legislation was drafted. 3 years later, in March 2021, the procedure started working and the first BMCP permission for clinical trial was issued to GENERUM. Biotechnology company Generium has received approval to conduct a Phase III clinical
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Identification is one indicator of the quality of biomedical cell products. Product identification is a set of characteristics, specific indicators that distinguish a given product from others. (Read more about other quality measures in our article https://beawire.com/ru/2018/07/26/biomedical-cell-products-quality-indicators/). In the Russian Federation today there is no experience in carrying out an examination of the quality of BMCP, but the world experience
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The first license for production of BMСP was obtained. Licensing of BMСP production was one of the key problems in bringing such products to the Russian market. We have published several articles covering the requirements for the applicant of the license (https://beawire.com/ru/biomedical-cell-products/licensing-of-biomedical-cell-products-production-activities/https://beawire.com/ru/biomedical-cell-products/licensing-of-biomedical-cell-products-production-activities/), as well as the success of some companies in licensing the production of BMСP (https://beawire.com/ru/2019/04/08/bmcp-problems-and-prospects-of-development-in-russia/). According to the
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More than two years have passed since the coming into force of the Federal Law No. 180 “On biomedical cell products”, however, no production site has yet passed the licensing procedure and no drug did not set foot on the national registration trail. Meanwhile, the EAEU market is becoming increasingly accessible not only for medicines and medical devices, but also
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More than a year has passed since our latest publication dedicated to CAR-T therapy — cell products belonging to the BMCP category. Since then, the Russian Federation has introduced several normative legal acts regulating the process of registration of BMCP, and it would seem that the process of putting into circulation such high-tech products, slowly but surely acquires standardized forms,
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Following the last session on biomedical cell products (BMCP) within IPhEB 2019 (read more in the article), there was published the Order on the administrative regulations for the provision of licensing services for the production of BMCP on the website of Roszdravnadzor. Licensing of production has long been a pressing problem in the organization of introduction of BMCP into circulation.
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In April 2019, within the framework of the IPhEB Russia exhibition, held in St. Petersburg, a thematic session “Development of biotechnological direction in the pharmaceutical industry” was held. The session was devoted to various aspects of the life cycle of biomedical cell products (BMCP) and prospects of such products entering the Russian market. Currently, in Russia there is no registered
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In the section on the application of biomedical cell products (BMCP), a great deal of attention was paid to the various aspects and stages of registration. However, it is still unclear who will check the formed registration dossier at the stage of examination of BMCP? What are the requirements for experts and what level of training should they have? It
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In the section devoted to biomedical cell products, much attention was paid mainly to the legal aspects of the circulation of this type of product, as well as to the basic procedures that make up the life cycle of BMCP. However, this article is devoted directly to BMCP – the newest and promising method of treatment of cancer, in particular
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The Russian government has introduced a temporary permitting procedure for the import into the Russian Federation of biomedical cell products (BMCP). The relevant decree of the Government of the Russian Federation of 16.10.2018 No. 1229 was signed by Prime Minister Dmitry Medvedev. Permission for temporary admission will be valid from November 1, 2018 to April 30, 2019 and will apply
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