Tag Archives: drugs

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

Read more

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

Read more

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

Read more

Probiotics and prebiotics — is there any difference?

Often, food advertisements have the following phrases: “enriched with probiotic” or “contains prebiotics.” These two words differ in only one letter, but is there any meaning behind this different spelling? According to WHO definition probiotics are nonpathogenic to human bacteria that have antagonistic activity against pathogenic and opportunistic bacteria and restoring normal microflora. It appears from the definition that probiotics

Read more

The role of iodine in humans and iodine deficiency diseases

Introduction According to the Clinical Recommendations for Iodine Deficiency Diseases and Conditions, there are no territories in Russia where the population is not at risk of iodine deficiency diseases (IDD). Iodine consumption in Russia is much lower than the recommended – 45-50 µg per day, while the daily requirement for an adult is 150 μg. Why is iodine so important

Read more

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

Read more

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

Read more

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

Read more

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.

Read more

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

Read more
« Older Entries