СТРАТЕГИЯ ВНЕДРЕНИЯ СОВРЕМЕННОЙ ЦИФРОВОЙ СИСТЕМЫ ОТСЛЕЖИВАНИЯ В ОБРАЩЕНИИ ФАРМАЦЕВТИЧЕСКОЙ ПРОДУКЦИИ

doi:10.28942/atuj.v6i2y2026.150

Абстракт

Данная статья посвящена исследованию научно-теоретических и практических аспектов внедрения современной цифровой системы Track & Trace в обращении фармацевтической продукции. Исследование проведено в публичном юридическом лице «Аналитический экспертный центр» Министерства здравоохранения Азербайджанской Республики и направлено на оценку внедрения механизмов цифрового отслеживания в системе обращения фармацевтической продукции. В статье анализируются модели отслеживания, разработанные в рамках нормативных требований Директивы Европейского союза по борьбе с фальсифицированными лекарственными средствами (FMD) и Закона США о безопасности цепочки поставок лекарственных средств (DSCSA), а также оцениваются возможности их адаптации к национальным условиям. На основе проведённого анализа предлагается поэтапная стратегия внедрения, адаптированная к национальному контексту. Модель включает уникальную идентификацию фармацевтической продукции, обмен данными в режиме реального времени по всей цепочке поставок, а также централизованный государственный контроль через единую цифровую платформу. Предлагаемая стратегия способствует предотвращению обращения фальсифицированной и некачественной фармацевтической продукции, повышению эффективности регуляторного контроля и укреплению общей безопасности в системе обращения лекарственных средств.

Сопроводительное письмо

INTRODUCTION The circulation of pharmaceutical products represents one of the most sensitive and high-risk areas of the healthcare system. Fragmented and non-integrated control mechanisms across supply chain stages significantly increase the risk of falsified and substandard pharmaceutical products entering the market. According to the World Health Organization, up to 10% of medicines in low- and middle-income countries are estimated to be substandard or falsified, with this figure exceeding 20% in certain regions characterized by weak regulatory control. Additionally, global pharmaceutical supply chain inefficiencies result in substantial financial losses annually, further emphasizing the need for transparent and traceable systems.

Existing regulatory mechanisms are largely based on retrospective inspections, limiting real-time visibility and responsiveness. Therefore, the development of scientifically grounded and technologically advanced tracking systems is essential. In recent years, the implementation of digital Track & Trace systems has become a strategic priority in developed countries. Within the European Union (FMD) and the United States (DSCSA), continuous tracking of pharmaceutical products through unique identifiers has been established as a legal requirement. However, direct replication of international models does not always yield effective results due to differences in legal frameworks, institutional structures, and technological readiness. Thus, the implementation of Track & Trace systems should be approached as a legal, institutional, and technological transformation. The objective of this study is to develop a scientifically substantiated national strategy for implementing a modern digital tracking system adapted to Azerbaijan’s healthcare and pharmaceutical environment.

MATERIALS AND METHODS The study is based on national and international scientific publications, regulatory documents of international organizations (WHO, European Commission, FDA), and legal frameworks related to pharmaceutical circulation. A systematic approach was applied to analyze the pharmaceutical supply chain as an integrated system. Comparative analysis was used to evaluate international Track & Trace models (FMD and DSCSA) and their applicability to national conditions. Regulatory analysis assessed legal requirements and institutional competencies, while structural-functional analysis identified the roles of stakeholders (manufacturers, importers, distributors, pharmacies, and regulators). Based on the findings, a phased strategic implementation model was developed.

RESULTS AND DISCUSSION The study substantiates the strategic importance of implementing a modern digital Track & Trace system at the national level. Unlike existing international models, the proposed strategy introduces several novel elements:
• Integration of risk-based regulatory control mechanisms
• Adaptation to institutional and technological readiness
• Implementation of a phased transition model
• Establishment of a centralized state-controlled digital platform

These features distinguish the proposed model from standardized international approaches. Analysis of international experience demonstrates measurable outcomes. In the European Union, the implementation of FMD has significantly reduced the penetration of falsified medicines into legal supply chains. Similarly, the U.S. DSCSA framework has improved traceability and reduced the time required for product recalls. These findings confirm that digital traceability systems enhance both patient safety and regulatory efficiency.
At the national level, key challenges include:
• Fragmented control mechanisms
• Limited data integration
• Insufficient digital infrastructure

The proposed model addresses these challenges through phased implementation and stakeholder integration. Target benchmarks:
 90% traceability coverage
 30% reduction in regulatory processing time

CONCLUSION This study demonstrates that the implementation of a modern digital Track & Trace system can increase traceability coverage of pharmaceutical products to over 90% within a phased implementation framework, significantly reducing the risk of falsified and substandard pharmaceutical products entering the supply chain. International experience shows that such systems can reduce the detection time of unsafe products by up to 50% and substantially improve regulatory response efficiency. The proposed strategy is specifically adapted to the legal, institutional, and technological conditions of Azerbaijan. It ensures practical feasibility through gradual implementation while maintaining alignment with international best practices. The results indicate that successful implementation will lead to:
 Increased transparency in pharmaceutical circulation
 Improved regulatory efficiency
 Enhanced patient safety
 Reduced operational costs

Thus, the proposed model represents not only a theoretical contribution but also a practical roadmap for the digital transformation of pharmaceutical regulation in Azerbaijan.

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Ссылки

1.“Amendments to the Law of the Republic of Azerbaijan “On Medicines” (Law No. 979-VIQD) (2023). Baku.
2.Resolution of the Cabinet of Ministers of the Republic of Azerbaijan on the Application of Electronic Healthcare Systems. (2021). Baku.
3.Relevant executive authorities of the Republic of Azerbaijan (Ministry of Health, Analytical Expertise Center of the Ministry of Health, etc.). Methodological guidelines and official reports on the circulation and regulatory control of pharmaceutical products.
4.Strategic documents and program materials related to digitalization processes in the healthcare and pharmaceutical sectors of the Republic of Azerbaijan.
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