Russian Regulatory Framework Research Articles

Novelties in the regulatory practice of reporting on sustainable development in the Russian Federation

Subject. The article analyzes the latest changes and trends in the regulation of sustainable development reporting in the Russian Federation. Objectives. The study is aimed to review the Russian regulatory framework for organizing and reporting on sustainable development in the context of expanding the agenda of the Sustainable Development Goals, consider the key aspects of sustainable development reporting in the Russian jurisdiction, including new requirements, methods of measuring effectiveness reflected in guidance documents of Russian regulators. Methods. The study employs general scientific research methods, like detailing, generalization, analysis, synthesis, and description. Results. The regulation of the process of reports on sustainable development preparation is being transformed in response to the changing market conditions and emergence of global reporting standards. The current state of regulatory practice is characterized by the lack of legislative consolidation of the obligation to prepare reports, which complicates the process of data comparability of these organizations demonstrating a responsible approach to business. I analyzed the approaches of the Bank of Russia and the Ministry of Economic Development of the Russian Federation to take into account ESG factors in the formation of the reports. Conclusions. The fragmented regulation of the preparation process of reports on sustainable development is caused by the absence of a single legal instrument of mandatory application, the existence of internal initiatives of regulatory authorities aimed at improving the reporting practices of economic actors who chose a sustainable development vector.

Drivers of Pharmaceutical Compounding: Regional Experience Analysis Using Irkutsk Pharmacy Organisations as a Case Study

INTRODUCTION. National pharmacy compounding is a priority for providing the population with medicinal products, particularly the medicinal products lacking in the Russian Federation. Investigating opportunities to improve the operation of compounding pharmacies in the Russian Federation remains essential, especially in the context of the developing personalised approach to treatment, growing practice of orphan drug development, and import substitution needs.AIM. This study aimed to identify the factors driving the development of compounding pharmacies under the current conditions.MATERIALS AND METHODS. The study focused on the Russian regulatory framework for pharmacy compounding, as well as the range of dosage forms and administration routes of the medicinal products that had been produced and packaged by the compounding pharmacies in Irkutsk in 2021–2023.RESULTS. This study showed a demand for compounded medicinal products among both healthcare providers and patients. These medicinal products covered a traditional range of compounded medicines, including custom formulae, medicines for paediatrics and geriatrics, stock preparations, and pharmacy-packaged items. In 2021–2023, the mean annual production of Irkutsk pharmacy organisations amounted to ~500,000 units of compounded medicinal products, with a variety of doses and dosage forms. The medicinal products were compounded using ~100 different active substances and over 20 approved medicinal products. This study examined the evolution of Russian pharmacy compounding legislation. The key aspects included the establishment of a pharmaceutical quality system for compounded medicinal products, the extension of shelf life for specific dosage forms, and the authorisation to use medicinal products approved in the Eurasian Economic Union in compounding. The study showed that the main factors driving the operation of compounding pharmacies were the ongoing regulatory framework transformation and the transition from standardised treatment to personalised medicine. The main impediments for compounding pharmacies included the lack of state support, the ban on compounding medicinal products produced by pharmaceutical companies, the shortage of skilled staff, the inadequate supply of equipment (first of all, production machinery), the poor availability of active substances and excipients in small packages, and the challenges associated with regulatory control and oversight over the quality of compounded medicinal products.CONCLUSIONS. Further stimulation of the active development of compounding pharmacies requires further investigation into their operation in other regions, which will help to develop legal arrangements for the federal and regional state support of compounding pharmacies, procure up-to-date materials and equipment, and train the staff for compounding pharmacies.

Подход к оценке мониторинговых уровней оперативного вмешательства после аварии на АЭС с использованием системы RODOS

The paper presents a comprehensive analysis of the IAEA's methodology for calculating the operational intervention levels (OILs) to protect the public in the aftermath of a radiation disaster based on monitoring data. Developing the OILs assessment approach involves outlining specific indicators based on accident scenario characteristics, geographical location of nuclear power plants, timing after releases, and dose criteria established by the Russian regulatory documents. The paper highlights the feasibility of using a unified computation tool to solve interconnected tasks, such as "prediction of radiological consequences" and "development of monitoring OILs". A methodological approach to assessing monitoring OILs using RODOS models, designed for predicting the consequences of a radiation accident, has been developed. This approach includes three stages: assessing the radiological significance of a scenario, evaluating monitoring OILs for different generic criteria, and justifying the recommended values of OILs. Calculations were performed to show how the new methodology can be used based on the data for the most severe possible accidents at VVER-440, VVER-1000, VVER-1200, and BN-800 reactors. The results showed that the maximum radiation doses for the prospective BN-800 and VVER-1200 reactors do not exceed the dose criteria for evacuation of the public. The dynamics of OILs were computed for the most severe accident scenario at the VVER-440 reactor, using the "ambient dose rate" metric and "evacuation" dose criteria for effective and thyroid exposure, which are justified in the Russian NRB-99/2009. The OILs obtained through the presented methodology have been compared to the aggregated values of the same indicator calculated using the IAEA methodology in a "ground scenario". Further research is needed to validate monitoring techniques for potential accidents at Russian nuclear power plants. The research should consider regional conditions and the Russian regulatory framework.

НАУЧНО-ПОПУЛЯРНЫЙ ТУРИЗМ КАК НОВОЕ ТУРИСТИЧЕСКОЕ НАПРАВЛЕНИЕ В ЭКОНОМИКЕ РОССИИ

Since there is no definition of “popular science tourism” in the Russian regulatory framework, therefore, with the help of systematization and classification of types of tourism, in this article we will describe the content of its conceptual apparatus, which will serve to identify the main participants in its popularization and financing methods.

МЕТОДОЛОГИЧЕСКОЕ ОБЕСПЕЧЕНИЕ ИМПЛЕМЕНТАЦИИ МЕЖДУНАРОДНЫХ СТАНДАРТОВ ПО БЕЗОПАСНОСТИ ПОЛЕТОВ В РОССИЙСКИХ НОРМАТИВНЫХ ДОКУМЕНТАХ

The present paper delves into the challenge of implementing international flight safety standards into the Russian regulatory framework governing the establishment, application, and refinement of aviation safety management systems (SMS) in the civil aviation sector in Russia. It underscores the reliance of SMS regulatory adherence on the Standards and Recommended Practices (SARPs) set forth by the International Civil Aviation Organization (ICAO). The paper conducts an examination of prevailing discrepancies, indeterminacies, and ambiguities in delineating core terms and concepts within the English and Russian renditions of ICAO SARPs documentation. Furthermore, it offers an evaluation of the implementation hurdles associated with SARPs in regulatory documentation pertaining to civil aviation flight safety in Russia. The deficiencies in the regulatory infrastructure for flight safety in Russia are substantiated. Drawing from practical insights gained in formulating and improving regulatory and methodological support for SMS in prominent Russian airlines, the paper proposes measures to mitigate inaccuracies and uncertainties in the integration of ICAO SARPs editions within the Russian regulatory framework for aviation industry service providers.

Нормативная база регулирования деятельности крестьянских (фермерских) хозяйств в России

The agro-food complex of the Russian Federation has become one of the powerful drivers of the country’s economic development, providing an increasingly high level of food security. The experience of the formation of the agricultural sector of the European Union, dating back more than 70 years, shows that the leading role in its creation was initially played by the adopted legal documents, in particular, articles 38-47 of the Treaty of Rome of 1958 («Treaty Establishing the European Economic Community»). A skillful combination of administrative and economic regulation measures and constant adjustment of the legal framework have ensured the effective functioning of European agricultural producers, among which farms have a special status. In the Russian Federation, the role of farmers as producers of agricultural products is also growing from year to year. This paper examines the historical and modern aspects of the formation of the Russian regulatory framework for the functioning of peasant (farmer) farms as a special group of agricultural producers that emerged as a result of the reforms of the 90s of the last century. The article highlights the dual nature of peasant (farmer) farms as commodity producers and as a social group uniting rural residents interested in its development and evaluates the existing tools for supporting farmers and their effectiveness.

Audit of Non-Financial Reporting in the Focus of Sustainable Development of Russian Companies

Introduction. The article provides an analysis of applying standards of quality management system, audit and sustainable development in Russia for confirming non-financial reporting of organizations. The Russian regulatory framework for confirming the reliability of non-financial reporting in the context of sustainable development was reviewed. The types of independent external confirmation initiated by the organization that issued non-financial statements were examined. A comparative structural analysis of standards for confirming non-financial reporting, which are used in Russian business practice, was carried out. Objective: The study of the concept of the reliability (audit) confirming of non-financial reporting in domestic organizations and identifying measures to improve the efficiency of the audit procedure and procedures. Research design: The object of the study was the conceptual provisions for constructing a domestic system for confirming the reliability of public non-financial reporting. The basis of the research was legislative and regulatory documents, studies and analytical reviews of professional communities, and the works of domestic scientists. The work was based on traditional methods of studying, such as comparative analysis, monographic, abstract-logical and calculation-constructive. Results: The author determined his own judgment about the components of the development paradigm of the institution of confirming the reliability of non-financial reporting in Russia. The article presents directions for improving the legal regulation of procedures for assessing and confirming the reliability of non-financial reporting.

Updating of legal regulations as a tool to reduce property and legal risks during mergers and acquisitions

The essence of mergers and acquisitions (M&A) deals is to reorganize the business, primarily in order to increase profits, strengthen its position in the market, and get rid of a competitor. Mergers and acquisitions help businesses increase their assets. In accordance with the Russian regulatory framework, which regulates corporate relations in the organization, acts have been adopted regulating various aspects of activities in Russian commercial organizations, including mergers and acquisitions. The paper notes that the main problem of M&A transactions is that the legislation of the Russian Federation lacks specific rules for regulating the process of mergers and acquisitions. Such a lack of specific laws, as well as regulatory legal acts, hinders many processes in conducting mergers and acquisitions, thereby increasing the level of regulatory risk. In addition, there is practically no legislative control over the M&A process in the Russian Federation. It is concluded that it is necessary to develop and improve the regulatory framework as one of the risk management tools that reduces such types of risks as market, credit, financial, liquid, loss of solvency, financial stability, etc.

Проблема дивергенции оценок, присуждаемых лицами, оказывающими услуги по оценке устойчивого развития. Главные тренды в области законодательного регулирования института ESG-рейтингования в России и мире

Confidence in environment, social, and governance (ESG) ratings among investors remains at a fairly low level. An Edelman Insights study [2021] reported that almost three out of four institutional investors do not trust companies to achieve their stated commitments in the fields of sustainability, ESG, or diversity, equity, and inclusivity (DEI). One of the reasons for this distrust is the divergence of ESG ratings – that is, the difference in ratings given by different ESG agencies to the same companies. The origins of this problem lie in the fact that there is still no developed framework to regulate the process of assessing the sustainable development of companies. However, more and more international actors are becoming involved in this issue in order to increase confidence in the assessments of ESG rating providers. For example, codes of conduct for data and ESG ratings providers have already been issued by the United Kingdom (UK), the European Union (EU), India, and Japan. The Central Bank of Russia also issued an information letter on the regulation of the activities of ESG rating providers in the summer of 2023. This article studies the problem ESG ratings’ divergence and determines ways to solve it through the development of regulatory control. It also studies the main trends in the legislative regulation of this institution in order to implement them into the Russian regulatory framework. In this regard, an analysis of work by Russian and foreign researchers devoted to the study of differences in ESG ratings was carried out; additionally, the main approaches of international organizations and legislative bodies of Russia and other countries in the sphere of regulating ESG information providers and mandatory non-financial reporting of companies were studied. The main problems affecting the reduction of ESG data correlation are identified, solutions for them are proposed, and the key trends in improving the comparability of ESG ratings by international actors are noted. The comparative legal method was used in the study. The analysis shows that international actors resolve the problem of divergence by increasing their interpretability, but not through strict regulation. They propose to develop basic recommendations regarding methodologies, evaluation criteria, and weighting factors, while at the same time consolidating the responsibility of ESG rating agencies to disclose their methodology, the terminology used, and their rating definitions. The task is to create harmonized standards for, and transparency of, the ESG assessment process.

Monitoring of international standards in the field of ISO/TC 71 “Concrete, reinforced concrete, prestressed reinforced concrete”

Introduction. The article is based on the results of monitoring the regulatory framework of international standards in the field of ISO/TC 71 “Concrete, reinforced concrete, prestressed reinforced concrete”. Monitoring and analysis of newly developed and updated international standards is done to identify gaps in the domestic regulatory framework, to find duplicate or contradict regulatory documents, to establish relationships with regulatory documents related to adjacent areas, to monitor and analyze existing regulatory technical documents for the sufficiency of requirements in the field of the committee’s activities, to prepare proposals for the development of mandatory construction norms.The aim is to analyze and compare the international and Russian regulatory and technical base for its timely updating and elimination of emerging duplications and contradictions, to increase the level of harmonization of Russian and international norms and standards in the field of construction of buildings and structures, from the point of view of introducing progressive domestic developments into the regulatory framework, to develop proposals for amendments to regulatory technical documents and development of new regulatory documents in this area.Materials and methods. International ISO standards were selected as the material, and European and American standards were compared with their Russian counterparts for further analysis.Results. The article provides selective monitoring, analysis and comparison of ISO standards and the Russian regulatory and technical framework for its timely updating and elimination of duplications and contradictions, increasing the level of harmonization of Russian and international norms and standards in the field of construction of buildings and structures ISO/TC 71 “Concrete, reinforced concrete, prestressed reinforced concrete”. Nine international ISO standards have been analyzed with a view to possible harmonization with Russian national standards.Conclusions. Based on the results of monitoring:1. 9 ISO/TC 71 standards “Concrete, reinforced concrete, prestressed reinforced concrete” are considered. The systematization of the current ISO standards related to the field of activity of ISO/TC 71 “Concrete, reinforced concrete, prestressed reinforced concrete” has been carried out.2. The closest analogues of normative technical and methodological documents in the national standardization system for the analyzed ISO standards are identified and analyzed.3. Proposals have been prepared for the development of new and updating previously approved codes of rules, building codes and regulations.

ОСНОВНЫЕ НАПРАВЛЕНИЯ СОВЕРШЕНСТВОВАНИЯ ДЕЙСТВУЮЩИХ НОРМ И ПРАВИЛ ОБЕСПЕЧЕНИЯ РАДИАЦИОННОЙ БЕЗОПАСНОСТИ. ЧАСТЬ 1. МАСШТАБ ПРОБЛЕМЫ И ПУТИ ЕЕ РЕШЕНИЯ

Purpose: To justify the necessity to update the radiation safety standards in our country and to propose the main directions for revising the Russian regulatory framework in the field of radiation safety. Material and methods: This paper considers the phases of development of the radiation safety regulation system in Russia. It is noted that for the first time a full-fledged three-level system of radiation safety regulation was created in Russia in the early 2000s. A generalized analysis of new international documents in the field of radiation safety system, which are worth using in the Russian regulatory framework, is presented. Results: The main directions of the revision of the Russian regulatory framework in the field of radiation safety are: introduction of new concepts and current terminology; introduction of “soft” standards, which are reference levels and the so-called “dose constraints” (it is desirable to give this term a different Russian name); updating the principles and standards of emergency response; updating the dose coefficients taking into account new biokinetic models, extension of the list of radionuclides and pathways; introduction of special approaches in the field of internal dosimetry and regulation of radiation protection of workers under management of radionuclides with a long effective half-life of clearance from the human body (isotopes of plutonium and 90Sr); use of principles and standards according to the concept of exclusion, exemption, and clearance to justify the criteria for classifying various media as radioactive waste and waste with a high content of radionuclides; development of standards and rules for maintaining the radiation safety of workers and the public during the decommissioning of radiation facilities and the rehabilitation of contaminated areas. Conclusion: For the successful implementation of the work to be done, it is important to combine the efforts of the Russian scientists and practitioners who have accumulated extensive experience in the field of radiation safety. The high potential of the Russian specialists makes it possible to carry out this work in a short time. A necessary condition for the implementation of these works is the introduction of amendments to the Federal Law of 09.01.1996 No. 3-FL «On Radiation Safety of the Public».

Review of the Certification Procedure for Qualified Persons of Manufacturers of Medicines for Human Use in Russia

Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for human use in the Russian Federation. To accommodate these changes, the Russian regulatory framework needs further improvement.Aim. This study aimed to review the changes made to the mechanism of state regulation of medicines and to evaluate the impact on the pharmaceutical industry two years after the adoption of the current QP certification procedure.Discussion. This review compares two QP certification procedures established by Order No. 7n of the Ministry of Health of the Russian Federation dated 12 January 2021. The first is an abbreviated one for QPs certified under the previous procedure, and the second is an initial one for QPs being certified for the first time, having an expired certificate, or wishing to extend their professional qualification profiles. The article illustrates common mistakes made by certification applicants when preparing their documents. Furthermore, the authors describe the most prevalent knowledge gaps identified by testing. The abbreviated certification procedure ensured a sufficiently smooth transition to the EAEU requirements. For example, by 1 February 2023, 506 QPs were recertified for the next five-year period according to this procedure. This accounts for slightly more than half of all QPs certified in the Russian Federation according to the previous requirements. The total number of QPs certified according to the EAEU requirements in Russia in 2021–2022 is approximately 1.5 times higher than the number of QPs certified during the same period in 2014–2015.Conclusions. The updated procedure for QP certification has noticeably changed the occupational group of QPs formed in the Russian Federation in the last decade. The implementation of the new QP certification procedure has revealed several procedural issues that require additional explanation and clarification by the Ministry of Health of the Russian Federation.

Analysis of New Standards in the Field of UV - C Disinfection

The coronavirus pandemic continues to plunge the world into waves of a potentially deadly disease caused by multiple strains of the SARS-CoV‑2 virus. A well-known effective method of non-specific prevention of the spread of respiratory viral infections in the Russian Federation is air disinfection using ultraviolet (UV) germicidal irradiation. Today, in medical institutions the application of this technology bases on domestic guidelines developed without taking into account the characteristics of new viruses, new knowledges and technologies in the field of UV radiation generation. A number of new standards have been issued abroad, significantly deepening the knowledge and capabilities in the development and application of UV disinfection devices. This article provides an overview of new standards, highlights the provisions that are appropriate for harmonization with Russian rules and recommendations for the use of UV radiation. The article shows: the necessity of updating the Russian regulatory framework in the field of application of UV disinfection technology, the development of new or revision of existing documents by the bodies of the sanitary and epidemiological service of the Russian Federation in cooperation with competent technical organizations and specialists.

Innovations in the accounting policy of medical organizations in 2023

The article considers changes that should be made to the accounting policy of medical and other organizations in 2023. The changes are related to the update of the Russian regulatory framework in the field of accounting and taxation, which required changes to the working documents of organizations. The article, based on a consistent review of the new documents, considers those changes that should be made to the accounting policies of commercial medical organizations, as well asbudgetary, autonomous or state-owned medical institutions.

О точности разбивочной сети для строительства высокоскоростной железнодорожной магистрали

Geodetic support for the construction and operation of high-speed railway lines requires high-precision geodetic work both at the construction stage and during the operation of the facility. The ge-odetic setting-out network, being the basis for the construction of the highway, requires special care and high measurement accuracy for its creation. An analysis of the studies performed in this area shows their insufficiency or incorrectness, and a comparison of current regulatory documents shows their inconsistency. In this article it is calculated on the basis of the results of existing scientific works what should be the required accuracy of building a planned setting-out network for the construction of a railway with speeds up to 400 km/h. The correctness of the result obtained has been proved based on the analysis of existing regulatory documents of various countries providing high-speed rail communication. Based on the findings, practical recommendations on methods for constructing a planned setting-out network for the construction of a high-speed railway and fixing its points are given, which can significantly reduce the cost and labor intensity of work on its creation. The imperfection of the Russian regulatory framework in the field of construction of such facilities as well as the direction of further necessary research in the field of geodetic support for their construction are shown.

Approaches to the regulation of testing and the use of unmanned vehicles in Singapore

Singapore is one of the world leaders in the digital of the economy by many measures. By analyzing Singapore's experience in regulating the testing and application of unmanned vehicles, it is possible to find promising ways to develop the Russian regulatory framework in this area. The article examines the general framework for the development of the regulatory framework in the sphere of regulation of relations regarding the use of intelligent technologies, as well as the basic principles of regulation of testing and application of artificial intelligence. The analysis of the regulatory framework regulating the rules of unmanned vehicles in Singapore is carried out. The text explores common regulatory intervention strategies in the implementation of new technologies. The author’s team concludes that Singapore has moved away from a prohibitionist approach and a control-oriented strategy in the regulation of AI-driven vehicles. Authorities in Singapore combine different strategies to regulate the testing and use of unmanned in favor of an adaptation-oriented approach. A risk tolerance approach is also applied to the regulation of testing and application of unmanned vehicles.

Analysis of the Russian Regulatory Framework for Drone Development, Certification, and Use

Analysis of the Russian Regulatory Framework for Drone Development, Certification, and Use

Mechanisms for stimulating the implementation of projects in the sphere subsurgery waste handling

Background. The generalization of available information on the volumes of mineral resource waste accumulated in Russia and its use presents a relevant research task. In this regard, an analysis of the current level of use of accumulated mineral resource waste, as well as existing approaches to stimulating the involvement of that waste in economic circulation, is required.Aim. To substantiate the introduction of adequate and working mechanisms that would stimulate activities for the implementation of projects in the field of mineral resource waste management.Materials and methods. The present study is based on a systematic analysis of the current Russian regulatory framework in the field of the management of mineral resource waste, relevant scientific publications, as well as the data from the State reports “On the state and protection of the environment of the Russian Federation”.Results. The level of use of the accumulated mineral resource waste, despite its high resource potential, is two times lower than that in economically developed countries. An analysis of the reasons behind the low level of involvement of various types of mineral resource waste in economic circulation is provided. These reasons include the presence of administrative barriers in obtaining the right to use mineral resource waste and the lack of tax benefits and preferences, as well as the absence of mechanisms for obtaining preferential loans for mineral resource users implementing projects for the processing of such waste. The need to improve the current procedure for obtaining the right to use mineral resource waste objects by introducing a relative declarative is indicated. An analysis of the current mechanisms of tax incentives, guarantee, leasing and financial support for companies implementing projects for processing mineral resource waste is carried out. The insufficiency of these mechanisms and the need to provide additional tax benefits and preferences to such entrepreneurs is pointed out, including the introduction of differentiated MET (mineral extraction tax) rates. In addition, the possibility of using “green” financing mechanisms to stimulate the implementation of projects for the processing of man-made deposits, attracting “long” and “cheap” credit resources in the Russian and international debt financing markets, is analysed.Conclusion. Stimulating mechanisms for the implementation of projects in the field of mineral resource waste management are proposed, providing for the introduction of a simplified (declarative) procedure for granting small and medium-sized businesses the right to use mineral resource plots represented by man-made objects without bidding and one-time payments, as well as a differentiated approach to the collection of mineral extraction tax in the development of man-made deposits, and the use of “green” financing approaches to attracting concessional credit resources for the implementation of such projects.

Challenges in development and authorisation of gene therapy products

There are a lot of diseases known today, which are caused by genetic abnormalities. Advances in genetics and biotechnology brought about gene editing technologies that can produce almost any gene, which ultimately led to the emergence of a new class of medicines - gene therapy products (GTPs). The aim of the study was to analyse international experience in development and authorisation of GTPs. The review highlights the challenges in GTP development, related to the search for an optimal approach to therapeutic gene delivery to the target cells. Viral vectors were shown to be a promising gene delivery system, with adenovirus (AV) and adeno-associated virus (AAV) based products demonstrating the highest efficacy and safety. The paper reviews current approaches to gene editing that allow modification of AVs and AAVs to improve GTP efficacy and safety. These modifications are carried out with the aim of, e.g., including a large therapeutic gene into a viral vector, decreasing viral protein expression levels, and decreasing viral vector immunogenicity. The review summarises GTP authorisation procedures in the USA and the European Union, including data on FDA and EMA subcommittees and departments entrusted with advisory functions. The paper mentions that there is one Russian-produced GTP authorised in the Russian Federation, and some other GTPs are in the pipeline. Therefore, the Russian regulatory framework and the Eurasian regulations and recommendations should be updated in order to accommodate for GTP development and authorisation.

Organization of Hygienic Monitoring of Working Area Air Pollution by Particulates in Pharmaceutical Industries (Review)

Introduction.The use of highly active substances of various origins in the pharmaceutical industry exposes employees working directly with active pharmaceutical substances (APS) in manufacturing facilities to risks. Although pharmaceutical companies follow occupational safety requirements, such as the use of personal protective equipment (PPE), the manipulation of highly toxic substances in specially dedicated indoor facilities, etc., the impact of risk factors on the health of workers must be regularly assessed and monitored. Therefore, hygienic monitoring of working area air is obligatory in activity of pharmaceutical enterprises. A range of normative documents (orders, State standards, methodological guidelines, manuals) are currently in force in the Russian Federation defining uniform requirements for the organization and monitoring of working area air pollution by particulates. At the same time, the development of appropriate adjusted methodologies for determining the content of a specific substance in working area air is a mandatory requirement for all manufacturing enterprise by legislation.Text.The article provides a review of the Russian regulatory framework and relevant literature sources relating to the order of organization and performance of hygienic monitoring of working area air, including foreign ones. On the basis of a comparative analysis of the aforementioned literature completed in order to reveal common provisions, the comprehensive methodology for the monitoring of the content of harmful substances in the working area air at pharmaceutical enterprises is described.Conclusion.As a result of a comparative analysis of the literature reviewed, a detailed comprehensive methodology for the monitoring of the content of harmful substances in the working area air is presented, including a description of the equipment and materials required for sampling, sampling strategies, recommendations for monitoring protocols, procedures for storage and transport of samples, and procedure for sample analysis. This article may serve as a possible reference for pharmaceutical enterprises to develop individual methodologies for determining the concentration of a specific substances in working area air.