Category Archives: biomedical cell products

Provision of licensing of BMCP production

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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BMCP — problems and prospects of development in Russia

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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CAR-T therapy

 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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Temporary import of some biomedical cell products is approved

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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Introduction of changes in the registration dossier for biomedical cell products

In the section “Biomedical cell products” of our web site there were published a lot of articles, devoted to the analysis of normative documentation and scientific articles related directly or indirectly to the registration of BMCP. This article is devoted to the process of making amendments in the registration dossier for the already registered BMCP. What can be changed? –

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Import of biomedical cell product for the registration purposes

In late May, the Government of the Russian Federation approved regulation 633 “On amendments to the Rules of State registration of medical devices”, according to which the registration dossier should now include sample import permission, which certainly affected the process of registration of medical devices. (More on the link). The beginning of the summer was also marked by news concerning

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Biomedical cell products quality indicators

Currently, there is data on the development and patenting of more than 700 biomedical cell products (BMСP) for the treatment and prevention of various diseases. Of course, each of them should be an effective and high-quality product. According to the definition of FZ 180 “On Biomedical Cell Products” Quality of biomedical cell product is the correspondence of biomedical cell product to

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About biomedical cell product

Main information you should know about biomedical cell product in our great update: what is biomedical cell product by law? name of biomedical cell product – how to combine it how to store biomedical cell product (main questions from people who couldn’t understand how this “product” look like)? international regulation safety monitoring – what is the role of manufacturer and

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