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Tag Archives: drugs

Nomenclature of medicines within the framework of registration according to the rules of the EAEU.

Posted on Wednesday September 16th, 2020 by smmproexpert

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

drugs

The procedure for entering into civil circulation of medicines for medical use.

Posted on Monday July 6th, 2020 by smmproexpert

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

drugs

COVID-19. Are there any effective medicinal products?

Posted on Tuesday March 31st, 2020 by beawire

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

drugs

Market of registered pharmaceuticals for human use in Russia

Posted on Tuesday January 28th, 2020 by beawire

When registering medicines in the territory of the Russian Federation, information about them is reflected in the state register of medicines. The GRLS contains basic information about the drug (registration certificate number, date of registration and re-registration, information about the holder of the RC and the form of release, etc.) Interestingly, GRLS can be opened not only online, but also

drugs

Renewal of the drug registration within the framework of national regulation

Posted on Friday December 27th, 2019 by beawire

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

drugs

Omics technologies

Posted on Monday November 4th, 2019 by beawire

According to the Deputy Head of the Research Institute of Clinical and Experimental Lymphology for scientific work, Doctor of Medical Sciences Vadim Klimontov: “Omixes” are technologies which are based on the achievements of genomics, transcriptomics, proteomics, metabolomics, that means, sciences that study how the genome is arranged and how the information, which is encoded in it, implemented. How it is

drugs

Software and artificial intelligence in the development of modern medicines.

Posted on Tuesday October 22nd, 2019 by beawire

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

drugs

Orphan diseases

Posted on Thursday September 26th, 2019 by beawire

According to the All-Russian Society of Orphan Diseases, about 30 million patients with rare diseases were registered in the European Union. This means that every 15th European suffers from one or another orphan disease. The figures are impressive, given that the synonym for orphan diseases is “rare diseases”. Federal Law 323 states that orphan disease is a disease the prevalence

Approvals for drugs

Posted on Friday April 26th, 2019 by beawire

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.

drugs