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
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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
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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
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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
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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.
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