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

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

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

  Clinical investigations (CIs) of biomedical cell products (Biomedical cell products) are an integral part of the registration process. CIs are conducted on the basis of the permission to conduct CI of BMCP, issued on the basis of the results of the first stage of the expertise in the expert center of the Ministry of Health of the Russian Federation.

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? –

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