Author Archives: beawire

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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Classification of hospital cleaning trolleys as medical devices in the Russian Federation

When classifying devices as medical in the Russian Federation, the Federal Service for Overseeing Healthcare (hereinafter Roszdravnadzor) is guided primarily by the definition of medical devices as specified in Clause 1 of Article 38 of Federal Law No. 323-FZ dated 21 November 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (hereinafter Federal Law No. 323-FZ) and in Clause 2 of Decree No. 1416

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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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The Covid-19 environmental disaster

The covid-19 pandemic was a catastrophe of the 21st century, not only for humanity, but for planet Earth as a whole. Due to the epidemiological situation, people in many countries are still obliged to observe a mask regime. As a result, in Russia alone, about 10 million disposable masks are now being sent to the trash every day, and it

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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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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

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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

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Blockchain technology in medicine

Blockchain technology (BT) became popular with the development of cryptocurrency bitcoin in 2009. From that moment on, interest in this invention began to take place in many sectors of the economy, including medicine. In this review, we will try to explain as simple as possible what blockchain is and how it can be applied in the fields of medicine and

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The first clinical trial permission for biomedical cell product has been granted.

Clinical Study Part for BMCP was last updated on our website in 2018. This is because no special events have occurred since the legislation was drafted. 3 years later, in March 2021, the procedure started working and the first BMCP permission for clinical trial was issued to GENERUM. Biotechnology company Generium has received approval to conduct a Phase III clinical

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