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Scientific relevance. In recent years, antimicrobial resistance in pathogenic microorganisms has become a global problem that threatens the health of humans and animals and poses a risk to the biosafety of Russia.Aim. The study aimed to analyse the prevalence of antimicrobial resistance, consider the risks and medical consequences of this biological phenomenon, and suggest ways to optimise the use of existing antimicrobial agents and search for new ones.Discussion. The emergence of antibiotic resistance in bacteria is a natural biological process; the selection of resistant microorganisms occurs constantly with the use of the entire spectrum of antimicrobial agents in healthcare, agriculture, and other fields. The World Health Organisation (WHO) monitors these processes using the Global Antimicrobial Resistance Surveillance System (GLASS). Russia has adopted the Strategy to prevent the spread of antimicrobial resistance in the Russian Federation to 2030. The country has established a regulatory framework that supports the operation of the national antimicrobial resistance prevention system. The strategy to prevent the spread of antimicrobial resistance is being implemented through making organisational arrangements and developing novel medicines with mechanisms of action based on an understanding of the molecular mechanisms of infection and resistance. This review considers the main approaches to designing exploratory studies and evaluating the antimicrobial activity of the innovative molecules obtained. The rapid development of synthetic biology increases the likelihood of creating synthetic biological pathogens with high virulence and resistance to antimicrobial agents, which might pose risks of artificial epidemics.Conclusions. The antimicrobial resistance prevention system in Russia should be considered a strategically essential medical technology ensuring the biosafety of the country and the people.

RETRACTED ARTICLEThe present article considers the experience of a unitary expert and control authority regulating the circulation of medicines in the European Union (EU) – the European Medicines Agency. It also describes the main contents of the current EU regulatory documentation on the newly formed drug names eligibility criteria. These criteria are directed to protect consumer's rights and allow to prevent adverse effects on human health and life caused by the marketing authorization of new drugs, which names are identical or confusingly similar with the names of previously authorized products, but different in composition and effects.

Advanced therapy medicinal products (ATMP) represent a heterogeneous group of medicinal products, combined with the need for special regulation of their circulation. ATMP is a gene therapy medicinal products, a somatic cell therapy medicinal products, a tissue engineered products and combined ATMPs. The regulatory framework for ATMPs is established by Regulation (EC) No 1394/2007 on ATMPs which is designed to ensure the free movement of these medicines. The Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) was established in accordance with the Advanced Therapies Regulation as a multidisciplinary committee, whose primary responsibility is to assess the quality, safety and efficacy of ATMPs, and to follow scientific developments in the field. Since June 2009 the CAT issues scientific recommendations on ATMPs classification. CAT defines the strategy for the identification and analysis of risks associated with the clinical application of ATMP and risk factors determined by the quality of the product and the ratio of benefit-risk. The article presents methods of analysis of risk factors in the study of ATMP.

The complexity of therapy of lipid metabolism disorders is not only in comorbidity and polypragmasia, but also in predicting a genetically determined response to the treatment. The aim of our work was to study the pharmacogenetics features of pharmacotherapy of patients with non-alcoholic fatty liver disease, with various forms of IHD, and patients taking statins. We investigated 4 study groups: I — 60 patients with 2 type of diabetes and non-alcoholic fatty liver disease (APOE polymorphism); II — 187 patients with IHD (eNOS, AGTR2, CYP2D6 polymorphisms); III — 111 people with AH and CHF (polymorphisms: AGT: 704 (Met235Thr), AGT:521 (Thr174Met), AGTR1: 1166, AGTR2: 1675, CYP11B2: -344, GNB3: 825, ADD1: 1378 (Gly460Trp), NOS3: -786); IV — 62 patients taking atorvastatin (SLCO1B1*5 polymorphism). Patients with E2, E4 alleles of the APOE gene, taking essential phospholipids, improved parameters of total cholesterol, HDL, LDL, CA, AP; patients with E3 alleles had a positive dynamics of cholesterol, HDL, TG, LDL, VLDL, CA, urea. Patients having “slow” allelic variants of the gene CYP2D6*10, CYP2D6*4 had received metoprolol, had greater decrease in heart rate: 1.6 times for CYP2D6*10, 1.7 — for CYP2D6*4. Earlier debut of IHD is noted in patients with TT variants of the eNOS gene comparing the patients with GG and GT variants. Dosages of perindopril depend on AGTR2 gene polymorphisms. The prevalence of polymorphisms AGTR2: 1675, CYP11B2: -344, NOS3: -786, AGT: 704, GNB3: 825 increases with the increase in the stage of CHF. The parameters of intracardiac hemodynamics in patients with CHF are associated with AGT: 704, NOS3:-786, GNB3: 825, ADD1: 1378, AGT: 521 polymorphisms. Allele C of the SLCO1B1*5 gene is associated with an additional risk of statin-induced myopathy. So the treatment of diseases associated with atherosclerosis, needs using of a personalized approach for more effective and safe therapy.

The article describes the landmarks of control and licensing system development for the purpose of drug evaluation, marketing authorization and circulation in Russia. The need for the development of a state institution for performing expert evaluation of medicines was satisfied in 1990 by the establishment of the All-Soviet Union Scientific Centre for Expert Evaluation of Medicines (renamed in 1992 as the Russian State Centre for Expert Evaluation of Medicines - RSCEEM). The activities of the Centre included expert evaluation of all documents for new pharmaceutical products; organization and monitoring of clinical trials, as well as the assessment of their results; development of the recommendations regarding marketing authorization and medical use of new medicines. It also exercised the functions of the Federal Centre for Adverse Drug Reaction Study. RSCEEM became a basis for modern currently functioning Scientific Centre for Expert Evaluation of Medicinal Products».

The article presents generalized information about the program of the World Health Organization (WHO) related to International Nonproprietary Names (INN) of biological and biotechnological drugs. It reflects general principles for selecting INN for biological and biotechnological preparations, immunoglobulins (sera), preparations for gene therapy, glycosylated proteins and peptides, non-glycosylated proteins peptides and proteins, hybrid proteins, blood preparations, monoclonal antibodies, skin substitutes, transgenic products, vaccines, biosimilars. The conclusion was made about the need for an early solution to the global problem of assigning INN to biological and biotechnological drugs, while the number of authorized products remains relatively small.

The authors have analyzed international experience in creating legal documents regulating the use of animals for scientific purposes. Topical issues related to the use of laboratory animals for scientific purposes in the Russian Federation, including for the purpose of preclinical studies on the efficacy and safety of new medicines, are discussed. The negative effects of the lack a clear and consistent legal framework for the organization and limits of the use of laboratory animals for research purposes in the Russian Federation are identified. Particular attention is paid to the issue of bioethics, the principles of ethical expertise of research activities involving laboratory animals and the issues of bioethical committees activities. The basic directions of perfection of normative-legal acts and methodological documents in the field of organization and limits of the use of laboratory animals for research purposes are proposed.