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.
Read more
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
Read more
Certification of dietary supplements does not do without the development of regulatory documentation for the product. For carrying out work on hygienic examination and registration of dietary supplements the manufacturer, supplier or authorized representative provides various packages of documents depending on the origin of products. Thus, the technical documents on the dietary supplement of Russian production imply technical specifications, technological
Read more
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
Read more
1. Introduction The labeling of medical devices shall be a matter of crucial importance for the design, development, manufacturing and virtually every other phase of life cycle of medical devices, particularly during the operational period. However in real life, as one can see, manufacturers either do not duly care about label contents and description, or take every effort in order
Read more
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
Read more
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
Read more
An extensive group of medical devices (MDs) includes completely different products that may include different components. In the section devoted to MD, articles about drugs as part of MD have been published more than once (here and here). However, in addition to medicinal substances, various components of animal origin can be included in MD. Product overview Among the MD, which
Read more
After implementation of Federal Law, No 242-FZ dated 07.29.2017 “On the implementation of changes in certain legislative acts of the Russian Federation regarding the application of information technologies in healthcare” (also known as “the Telemedicine Act”), the question may emerge (and for many it has long since emerged): what is the proper definition for the term “telemedicinal device”. There are
Read more
On October 8, 2018, during the XXth Annual All-Russia Conference with International Participants “State Regulation of the Circulation of Medicinal Drugs and Medical Devices – FarmMedObrashchenie – 2018” (hereinafter FMO-2018), a Laboratory Services and Confidentiality Agreement was signed between the Pharmacopeial Convention of the USA and FGBU IMCEUAOSMP of Roszdravnadzor in the presence of Mr. Mikhail Murashko, the Head of
Read more