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

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

Since November 2019, the Resolution of the Government of the Russian Federation No. 1510, which defines the new order of entry of the drugs into civil circulation, came into force. Previously, drug release required obtaining a declaration of conformity or certificate of conformity. The batch of the drug was checked for compliance with the quality indicators specified in the regulatory

Since December 2019, the world has been struggling with a new infectious disease COVID-19 (COrona VIrus Disease 2019). This disease is caused by a virus belonging to the Coronaviridae family. The family includes two subfamilies and five genera which bring together more than 10 species that cause lesions of respiratory organs, gastrointestinal tract, nervous system in humans and animals. On

According to the Federal Law No. 61 “On Circulation of Medicines”, a drug, first entered the Russian market, receives a registration certificate for 5 years. During this period, its effectiveness and safety shall be monitored. Further registration must be confirmed. To do this, it is necessary to collect a certain package of documents and send the dossier for expertise. In

Development of new drugs is a long-term and expensive process. According to J. A. DiMasi et al, the development and implementation of a new drug on average takes about 8-10 years, and the cost of such a project is about 2.8 million US. dollars In Russia, development expenses are about 150-200 million rubles. In carrying out such large-scale tasks, of

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