The aim of the research was to study the current industrial practice of drug quality risk management in Russian pharmaceutical enterprises, including the assessment of the main problems during the implementation of the risk management system and its compliance with the accepted international approaches.Materials and methods. In the period from 6 April to 10 May 2020, an online survey of the leading employees in the field of quality assurance of Russian manufacturers was conducted. In the survey, the questionnaire was based on the results of the authors’ analysis of the national regulatory legal acts of the Russian Federation, the European Union countries, international guidelines of the EAEU, ICH and WHO in this area. 111 people took part in the survey, the return of questionnaires was 11.5%.Results. The data obtained indicate the prevalence of a superficial approach to quality risk management in the Russian pharmaceutical industry, the presence of objective and subjective reasons that hinder the effective implementation of these methods, the fragmentation of the systems used and, in most cases, their ineffective use. The respondents believe that the most significant reasons for the difficulties in implementing this methodology, are the lack of recommendations from the Ministry of Industry and Trade of Russia on creating an effective quality risk management system and a shortage of the specialists who are ready to work in the area of this industry. The survey revealed rather large gaps in the deployment of a risk management system at the enterprise and separation from the established international practice.Conclusions. The data obtained indicate the extreme urgency of developing recommendations for a quality risk management system, which should be based upon and supported by Russian regulatory legal acts and international experience in this area. The authors propose highlights for these recommendations.

Стратегия развития фармацевтической отрасли на период до 2030 г. (далее – Стратегия «Фарма-2030»), принятая в Российской Федерации в этом году, включает задачи по дальнейшему насыщению национального рынка отечественными лекарственными препаратами и по реализации экспортного потенциала фармацевтической отрасли. Государственное регулирование фармацевтической отрасли оказывает существенное стимулирующее влияние на экспорт лекарственных средств. Для выявления важнейших элементов этого регулирования, связанных с развитием и поддержанием устойчивого экспорта лекарственных средств, было проведено исследование регуляторных решений в сфере обращения лекарственных средств в странах, относящихся к разным сегментам мирового экспортного фармацевтического рынка. Результаты анализа государственного регулирования сферы обращения лекарственных средств в странах – центрах экспорта лекарственных средств были опубликованы ранее. В статье представлены результаты анализа государственного регулирования в странах с быстрорастущим фармацевтическим сектором, сформулированы общие для этих стран стратегии, которые направлены на достижение лидерских позиций национальной фармацевтической отрасли и на внутреннем, и на внешнем рынках. Также предложен ряд мероприятий для включения в план реализации Стратегии «Фарма-2030», которые, на наш взгляд, будут способствовать достижению поставленных задач как по стимулированию экспорта, так и по обеспечению лекарственными препаратами населения Российской Федерации.

Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of outsourcing and technical agreements there is a need to differentiate responsibilities related to quality assurance between the above mentioned categories.Text. The guidelines for the pharmaceutical sector of the European Union (EU) provide guidance on the responsibilities of the MAHs in relation to the GMP rules, which are scattered throughout the various chapters of the GMP and its appendices. In addition, certain provisions on this topic are contained in the EU directives. With this in mind the European Medicines Agency (EMA) issued in January 2020 a draft Reflection paper on Good manufacturing practice and Marketing Authorisation Holders. The draft clarifies that while certain activities of an MAH may be delegated to the manufacturer, MAH retains ultimate responsibility for the performance of a medicinal product, its safety, quality and efficacy. The important obligation of MAH in this context is to facilitate GMP compliance by establishing a robust two-way communication system with national competent authorities, manufacturing sites, Qualified Persons (QPs) certifying batches before release, and other interested parties. The MAH ought to communicate to manufacturing personnel, normally through QPs, production processes and related quality control procedures, including subsequent variations, described in registration dossiers.Conclusion. A general one conclusion: in view of rapid developments in the EU GMP Guide, the Eurasian Economic Union GMP requirements ought to be updated. In respect of specific responsibilities of MAH pertaining to GMP compliance the EMA draft Reflection paper merits attention as a guidance regarding separation of obligations and responsibilities between MAH and personnel of manufacturing sights.

Introduction. The article discusses significant changes in the procedure for pharmaceutical inspection of drug manufacturers for compliance with the requirements of the rules of good manufacturing practice (GMP) of the Eurasian Economic Union (EAEU), related to restrictions due to the COVID-19 pandemic.Text. The article presents the main international guidelines describing the remote conduct of pharmaceutical inspections, which is the basis for further updating the relevant procedures in the law of the EAEU. An overview of the foreign practice of pharmaceutical inspection during the pandemic is given. In addition, the changes in the Russian regulatory approaches to control and supervision in the Russian legislation are presented.Conclusion. These data give an idea that, with considering the above, there is a need for further convergence of the requirements, the practice of conducting pharmaceutical inspections for compliance with the requirements of GMP Rules in order to harmonize the norms between Russian regulatory documents, the norms of the EAEU law and international standards. This requires the development of a dialogue with the participation of stakeholders.

В текущем году в Российской Федерации принята Стратегия развития фармацевтической отрасли на период до 2030 г. В документе ставится задача обеспечения производства в стране лекарственных препаратов, конкурентоспособных на внутреннем и внешнем рынках, и «реализация экспортного потенциала фармацевтической отрасли». Особенностью фармацевтической отрасли является существенное влияние на экспорт различных аспектов государственного регулирования в сфере обращения лекарственных средств. Цель исследования – на основе анализа опыта зарубежных стран выявить важнейшие элементы государственного регулирования, способствующие формированию и развитию устойчивого экспорта лекарственных средств в условиях сложившейся олигопольной структуры экспортного сегмента мирового фармацевтического рынка. Учитывая объемность и разнообразие полученных данных, исследование было разделено на две части: анализ государственного регулирования сферы обращения лекарственных средств в странах – центрах экспорта лекарственных средств и в странах с быстро растущим фармацевтическим рынком. В настоящей статье рассмотрены особенности экспорта лекарственных средств и фармацевтического государственного регулирования в целом, приведен анализ стран-лидеров, выявлены основные факторы, ассоциирующиеся с успешными показателями экспорта, показаны текущие тенденции, предпринимаемые для удержания лидерства в этой области. Выявленные закономерности и регуляторные решения можно использовать для решения проблем региональных рынков на общенациональном уровне.

INTRODUCTION. In 2023, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a new Guideline on Analytical Procedure Development (ICH Q14) and a revised version of the Guideline on Validation of Analytical Procedures (ICH Q2(R2)). Consequently, there is a need for a considerable revision of the approach to the development and validation of analytical procedures that is currently used in the Eurasian Economic Union (EAEU). A revision is also needed for the processes for evaluating and introducing variations to the analytical procedures described in medicinal product registration dossiers.AIM. This review aimed to analyse the significant changes made to international approaches to the development of analytical procedures, as well as to study the advantages and disadvantages of these approaches for pharmaceutical manufacturers and regulatory agencies in the EAEU.DISCUSSION. This review covers the key provisions and practical aspects of the enhanced approaches to the development of analytical procedures introduced by the ICH Q14 guideline. In particular, the review addresses the concepts of the analytical procedure life cycle (APLC) and the modified analytical quality-by-design (AQbD) approach; the development of the analytical target profile (ATP); analytical quality risk management; planning of the design of experiments (DoE) and the analytical procedure control strategy; and the validation, subsequent verification, transfer, and change management of analytical procedures. Additionally, the review describes the ICH Q2(R2) updates that accompany this new regulatory paradigm.CONCLUSIONS. The above guidelines fill the existing gap in recommendations for the development of analytical procedures. The use of the APLC and AQbD concepts provides both pharmaceutical companies and regulatory authorities with flexible approaches that are applicable to analytical procedures both during the development phase and once they have been implemented. Effective implementation of these international approaches in the Russian pharmaceutical industry and regulatory system requires a broad discussion between pharmaceutical industry professionals and regulatory agency experts, possibly, as part of a pilot project. After that, there will be a necessity to provide training for specialists involved in the development of analytical procedures and to amend the EAEU Rules for Marketing Authorisation and Expert Assessment of Medicinal Products for Human Use.