Category Archives: drugs

Conditional and accelerated registration of drugs

In the previous article, we reviewed new registration procedures specific to certain drugs in accordance with the requirements of the EAEU. Currently, a drug be approved in the frame of approval procedure with post-registration obligations and in exceptional cases. In addition, Decision 36 also introduces conditional and accelerated registration, which will be discussed in this article. 1. Conditional registration (Section

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Fixed-dose combination finished pharmaceutical product (FDC-FPP)

With the entry into force of the EAEU registration rules, the classification of drugs has changed significantly, as we wrote in the article “NOMENCLATURE OF MEDICINES WITHIN THE FRAMEWORK OF REGISTRATION ACCORDING TO THE RULES OF THE EAEU”. (https://beawire.com/ru/2020/09/16/nomenclature-of-medicines-within-the-framework-of-registration-according-to-the-rules-of-the-eaeu/). However, the existing classification does not quite clearly describe such category of drugs as FDC-FPP. It is worth noting that its

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A carcinogenic impurity has been found in ranitidine drugs

In early October, the State Register of Medicines (GRLS) revealed the suspension of a number of ranitidine drugs intended to treat peptic ulcer disease.  The reason for the mass suspension was the conclusion of FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation which was based on information on the presence

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Biotech drugs: what are they?

Humanity now uses a huge number of biotech drugs without thinking about their origin and production process. Such drugs include, for example, insulin, hormonal drugs, vaccines, etc. Biotechnology (BT) drugs account for 29% of sales in Russia. BT drugs are expected to account for 35% by 2026. What does a “biotech” drug mean? What is its difference from “chemical” and

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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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Nomenclature of medicines within the framework of registration according to the rules of the EAEU.

Currently, under the national registration procedure, drugs can be divided into three groups: original, generic and immunobiological medicines. However, the time makes its adjustments, and the former classification can no longer take into account all the peculiarities of medicinal products on the market. In this regard, a new classification for registration purposes has been proposed according to the rules of

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