Public management of the sphere of circulation of medicinal products through the prism of the methodology for implementing PIC/S standards
Abstract
This article provides a theoretical and methodological substantiation of contemporary approaches to public governance in the pharmaceutical sector through an analysis of the implementation processes of PIC/S international standards into national regulatory practice. The conceptual evolution of approaches to PIC/S standards implementation is analyzed in the context of regulatory paradigm transformation from a command-and-control model to smart regulation. Key principles of international standards implementation are identified, including systemic approach, adaptability, proportionality, inclusiveness, transparency, evidence-based decision-making, innovation, and sustainability. The paper proposes a conceptual model for PIC/S standards implementation that integrates five interconnected components: strategic planning, institutional capacity building, legal-regulatory harmonization, procedural standardization, and information-technological integration. Factors influencing the effectiveness of implementation processes are identified and systematized, and a complex of practical recommendations for their optimization is developed. Based on the analysis of international experience, the research substantiates that the effectiveness of PIC/S standards implementation is determined by a complex of interrelated factors, with key elements being: political will and strategic vision, institutional capacity of regulatory authorities, quality of the legal-regulatory framework, change management system, technological capability, personnel competence, and international cooperation. The importance of a systems approach to developing these factors is demonstrated, emphasizing not their isolated improvement but the construction of an integrated regulatory ecosystem. The research establishes that optimizing PIC/S standards implementation processes requires developing a comprehensive strategy with priority directions: institutional capacity building, legal-regulatory framework harmonization, human capital development, digital transformation, and enhancement of international cooperation.
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