Federal Law No. 180 “On Biomedical Cell Products” is still in force in Russia. However, since 2016, registered products have not yet appeared on the market. In this article, we will try to figure out if there is any news in this area. Two years ago, the Russian full-cycle research and production company Generium received the first license for the

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

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

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

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

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,

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.

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

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