Currently, three vaccines against COVID-19 have been approved for use in the Russian Federation: “Sputnik V” developed by the National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya; “EpiVacCorona” developed by Vector Institute; “CoviVak” developed by the state-run Chumakov Research Center. The Sputnik V vaccine was released on the market first on August 8, 2020. According to theRead more
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Normative document for the pharmaceuticals. According to the definition of Decision No. 78 “On the Rules for Registration and Examination of Medicines for Medical Use” ‘normative document’means a document establishing requirements for the quality control of a medicinal product (it contains a specification and a description of analytical procedures and tests or references thereon, as well as appropriate acceptance criteriaRead more
At the end of February, it became known that the pharmaceutical company “Biotek” will become a supplier of the drug for the treatment of spinal muscular atrophy (SMA) nusinersen (TN Spinraza from Biogen and Janssen) for the sum of 128.8 million rubles for the charitable foundation “Circle of Good”. In addition to nusinersen, risdiplam (Eurisdi from Roche) and not yetRead more
To date, oxygen cosmetics is one of the most popular categories of cosmetic products. Of course, oxygen is necessary for every cell of the human body, including skin cells, but is it so easy to deliver it? And in general, what is meant by “oxygen” cosmetics? In the human body, the skin, unlike the lungs, is an almost gas-tight organ.Read more
Currently, many Russian people have deficiency in such biologically active substances as: polyunsaturated fatty acids, native (animal) proteins, vitamins (C, B1, B2, A, beta-carotene, E and others), mineral compounds (Ca, F, Fe), trace elements (Se, Zn, I, P). At the same time excess consumption of animal fats is observed. Even when the diet is calorie-balanced, the deficit for most vitaminsRead more
Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 1113n).
In the previous article devoted to the update regarding safety monitoring, we considered Order 980n “On Approval of the Procedure for Safety Monitoring of Medical Devices” . In this small review, we would like to refer to Order 1113n, which will replace the Order 12n on January 1, 2021 and will be valid until January 1, 2027. Before talking aboutRead more
Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 980n).
With the new year 2021, all subjects of circulation of medical devices, especially the manufacturer and its authorized representative (AR), expect innovations related to safety monitoring of medical devices. From January 1, 2021, two legislative acts (Order No. 980n from 15th Sept 2020 (monitoring system) and Order No. 1113n) come into force, which significantly details the procedure for interaction betweenRead more
Registration certificate (RC) is a document that confirms that a medical device can be used on the territory of the Russian Federation. The executive authority for monitoring and supervision in the field of organizing and ensuring the protection of public health is the Federal Service for Surveillance in Healthcare (Roszdravnadzor). All information about the registration process for a medical deviceRead more
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) belongs to the executive authorities and performs control and supervisory functions in the field of organizing and ensuring the protection of public health. When registering medical devices (MD), Roszdravnadzor relies on the Decree of the Government of the Russian Federation No 1416 “On Approval of the Rulesr State Registration of Medical Devices”Read more
During the COVID-19 pandemic, sectors of the economy such as education and health are particularly digitalized. Of course, it cannot be said that the current situation was a reason for the development of information technologies, but significantly contributed to the involvement of a large number of people in the transition to remote format of work. In this regard, telemedicine technologiesRead more