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

Our new topic about drugs regulation: what are drugs and how to determine it from borderline products? how to receive state registration and permission for clinical trials? what actions are required for pharmaceutical substance? Find answers in our new big topic – by link.