Tag Archives: drug

Review of vaccines against COVID-19 registered in Russia

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 the

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Normative document for the pharmaceuticals

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 criteria

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Gene therapy: a brief overview of the concept and approved drugs

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 yet

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Readability test.

As mentioned in our last article, within the framework of bringing the dossier into compliance with the requirements of the EAEU, it may be necessary to provide the patient leaflet (PL) and the results of readability test (more on this: https://beawire.com/ru/2020/09/21/procedure-for-bringing-the-registration-dossier-in-line-with-the-requirements-of-the-eaeu/). In this article we will try to elaborate on the readability test and the necessary format of its provision.

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Procedure for bringing the registration dossier in line with the requirements of the EAEU

Bringing the registration dossier into line with the requirements of the EAEU every day becomes an increasingly urgent task. This is quite natural, because the registration dossier for each medicine must pass this procedure until 31.12.2025. According to the single register of registered medicines of the Eurasian Economic Union (https://portal.eaeunion.org/sites/commonprocesses/ru-ru/Pages/DrugRegistrationDetails.aspxhttps://portal.eaeunion.org/sites/commonprocesses/ru-ru/Pages/DrugRegistrationDetails.aspx) 68 registration certificates have passed this stage. Compliance includes the

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Reference, generic and biosimilar drugs

As part of the consideration of the procedure for registration of medicines it is worth paying attention to such groups of drugs as reference (= Brand name), generic and biosimilar drugs. According to statistics, more than 60% of drugs on the Russian market are generics, or reproduced drugs. Definitions According to the Federal Law 61 reference drug is called a

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This Laboratory Services and Confidentiality Agreement is signed between the Pharmacopeial Convention of the USA and FGBU IMCEUAOSMP of Roszdravnadzor

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

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Special aspects of import of medical devices, which include precursors of narcotic substances

In the medical device market, there is a large number of products that contain various chemicals in the composition – active pharmaceutical substances, ancillary substances, as well as precursors of narcotic substances. This article is devoted to the peculiarities of the import of such devices. What are narcotic substances and their precursors? According to Federal Law No. 3 “On Narcotic

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Pharmaceutical substances and excipients

There are a few groups of medical devices, which have pharmaceutical substances in their composition. For example, filers with hyaluronic acid or stents with immunosuppressors. (details by link) However, medical devices can contain not only pharmaceutical substances but excipients. According to Federal Law 61 “On circulation of Medicinal Products” excipients are substances of inorganic or organic origin used in the

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Roszdravnadzor: Amendments to the Federal Law on the Circulation of Medicinal Products

  Federal Law No. 140-FZ dated June 04, 2018 On Amendments to the Federal Law On the Circulation of Medicinal Products entering into force on June 15, 2018 has been designed to amend the procedure for the submission of documents for the purpose of the state registration of medicinal products, confirmation of the state registration, and introduction of amendments into

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