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».

«Pyrogenicity» and «Abnormal Toxicity» are considered to be among most problematic pharmacopoeia monographs in the current editions of the leading world pharmacopoeias, the reasonability of which is not obvious to all experts. The authors analyze the reasons for the introduction and history of the elaboration of biological methods for drug quality control, as well as major prospects for their further development in Russia.

The article presents the review of the national regulatory documents on drug testing for microbiological characteristics, such as «Sterility», «Microbiological Purity» etc. It discusses the history of the establishment of characteristics and the elaboration of the related general pharmacopoeia monographs, as well as prospects for the development of methods in connection with the publication of the Russian State Pharmacopoeia XIII edition. There is a clear trend towards harmonization with the leading world pharmacopoeias, but the Russian State Pharmacopoeia maintains the individual characteristics of drug quality analysis in terms of microbiological characteristics, including the introduction of new technologies, process automation and taking into account the special features of individual drug groups.

Sampling procedure is an integral part of the drug quality control system. Objective science-based sampling is an important operation when only a small amount of a material is taken and it is representative for the analysis of the whole product batch. Reasoned conclusions about drug quality can only be based on the results of tests conducted on representative samples, taken in accordance with certain rules and regulations. For the purpose of harmonization with foreign normative documents, systematization and updating of the requirements for sampling, specifying their conditions, general pharmacopoeia monograph «Sampling» has been developed. It regulates general rules and special aspects of drug sampling procedures for the purpose of drug quality control. The general pharmacopoeia monograph «Sampling» consolidates and classifies the materials of legislative and regulatory documents of the Russian Federation, the WHO, the EU and international pharmacopoeia monographs.

The present article describes the approaches to the choice of methods for assessing the content of visible particles in parenteral and ophthalmic dosage forms, recognized in general pharmacopoeia monograph «Visible particles in parenteral dosage forms and ophthalmic dosage forms», as well as a special approach to the assessment of visible particles in individual preparations according to the batch volume, package type, the amount of drug in a package, drug nature etc., requiring unusual conditions and evaluation criteria.

The present paper conceptually considers scientific approaches to standardization of starting materials of herbal origin and herbal medicinal products. It was proved that chemical classification of the starting materials of herbal origin is of fundamental importance for Pharmacognosy and Pharmaceutical science in general. It was shown that the chemical nature of biologically active compounds has to be considered as a methodological basis when developing new approaches to standardization of starting materials of herbal origin and herbal medicinal products. The article also discusses the dependence of physical, physical and chemical, spectral, and pharmacological properties on the chemical nature of biologically active compounds, used as identity and quality criteria for raw materials and phytopreparations. The paper describes current trends in Pharmacognosy, as reflected in the State Pharmacopoeia of the Russian Federation XIII edition.

It is currently established that some low molecular weight peptides possess immunomodulating activity and are used as peptide preparations. One of the most important trace elements playing an important role in the functioning of the immune system is zinc. The performed research became the basis for the development of the immunomodulatory preparation timocin, in a form of aqueous solution of zinc coordination compounds with dipeptide isoleucyl-tryptophan, which has been registered in the Republic of Tajikistan as an immunomodulating preparation. The research allowed to perform standardization and develop pharmacopoeia monograph for the reference standard and the finished dosage form of the immunomodulatory preparation timocin.

Pharmaceutical reference standards systems have been analyzed. The imperfections of a one-level system have been demonstrated. It has been shown that for making a reliable decision on the quality of medicines one needs to use a two-level system, an important part of which is the system of secondary reference standards (SRS) of a facility. The article describes the experience in the development and implementation of the SRS system in Ukraine within the transition to a two-level system.

The general monograph developed for the Russian State Pharmacopoeia describes the opportunity for using special equipment called «elemental analyzer» to solve the problem of determining active ingredients in pharmaceuticals by determining the elements C, H, N, S. The method is based on the high-temperature oxidative decomposition in a stream of helium, or in its mixture with oxygen in the presence of an catalyst of oxidation to inorganic substances corresponding the mentioned elements, reduction of nitrogen oxides to molecular nitrogen in the presence of the respective reduction catalyst and determining the corresponding decomposition products by gas chromatography. This method is fast and does not require the analysis of a sample of an active substance.

Shared Knowledge Centre (Research and Education Centre) of the Peoples’ Friendship University of Russia (SKC (REC) PFUR) was established in 2009. It is equipped with modern advanced measuring and testing equipment. On the basis of SKC (REC) various scientific and research projects are conducted, such as the development and formulation of medicines; quality control and standardization of medicines and substances, etc. The research results became a basis for a number of general monographs and monographs to be included in the Russian State Pharmacopoeia XIII edition, in particular, «Mass Spectrometry», «Fatty oils» etc. At the moment the employees of SKC (REC) are developing technologies and methods of standardization for dosage forms such as transdermal patch, buccal films, floating tablet and other innovative dosage forms, which will be used for further development of the general monographs and monographs for the future Russian State Pharmacopoeia editions.

Two optical methods - polarimetry and laser light diffraction - have been used to study valine aqueous solutions. It has been shown that optical activity of valine enantiomers depends on deuterium content in aqueous solutions. The influence of deuterium-dependant heterophase clusters of water on optical activity of valine aqueous solutions has been discussed.

The present article describes the stages of the development of the test-system that allows to research the potency of GSK-3 inhibitors to induce endothelial progenitor differentiation and to increase cell survival in hypoxia in vitro. β4-thymosin, which shows anti-ischemic and angiogenic activity, has been used a reference preparation. The proposed experimental cell model can be useful in the preliminary testing of new chemical compounds in terms of their ability to treat ischemic disorders and it can be used as an alternative for procedures involving animal testing.

The article covers the issues of patent information retrieval technologies for the elaboration of draft pharmacopoeia monographs on immunobiologicals. It describes the opportunities of automated search in the databases of the Russian Federal Agency for Intellectual Property, Patents and Trademarks or the World Intellectual Property Organization. The article defines selection criteria for published patent documents in order to determine current invention patents, the essential features of which were used for the elaboration of draft pharmacopoeia monographs. The results of the study showed the need for patent information retrieval and result recording in the elaboration of draft pharmacopoeia monographs on immunobiologicals, which will allows to timely obtain an agreement of a patent holder for publishing information about the patented immunobiological medicines in the State Pharmacopoeia of the Russian Federation.

Traced the impact of genetic testing on the course of chronic heart failure in patients with arterial hypertension. Evaluated the clinical significance of the frequency of gene polymorphisms in patients with the chronic heart failure, depending on the success of treatment. All patients were refined risk factors were performed general clinical methods, electrocardiography (ECG), ECG monitoring, echocardiography, pharmacogenetic testing, analysis of outpatient pharmacotherapy for 1 year and 5 years. The use of genetic testing to determine the course of chronic heart failure, its prognosis and timely in view of the personalized approach to carry out the correction of pharmacotherapy in accordance with existing clinical guidelines and standards.