Author Archives: beawire

List of medical devices for fast track registration – increased by Government

List of type codes dated June 28, 2022 based on the results of a meeting of the interdepartmental commission on the formation of a list of types of medical devices subject to circulation in accordance with the Peculiarities of circulation, including state registration features of medical devices in the event of their defectiveness or the risk of defectiveness in connection

Read more

QMS inspection of medical device manufacturers

Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our comparison below: No. Item National system EAEU 1 Main document Decree of the Government of the Russian Federation No. 135 dated 09.02.2022 “On approval of the Rules for arranging and conducting inspections of the production

Read more

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

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

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

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

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
« Older Entries