Abstract
Introduction. The quality of public regulation of medicines circulation depends on a management control system that ensures the timeliness, quality, and transparency of expert processes. Traditional reporting mainly records deviations after they have occurred, which creates a need for a model that enables early risk identification and supports data-driven decision-making. Methods. This was an applied project-based study. A systems approach, a process approach, analysis of regulatory and methodological documents, comparative review of international recommendations for strengthening regulatory systems, and management process modelling were used. Results. A three-level management control architecture comprising strategic, process, and operational levels was proposed. A set of indicators was developed covering timeliness, process duration, risk of deadline violation, first-pass quality, rework, data quality, implementation of corrective actions, workload balance, and the degree of automation. The structure of a management dashboard and a phased roadmap for implementation were developed. Discussion. The proposed model supports a shift from retrospective reporting control to early identification of deviations, root-cause analysis, and monitoring of management actions. KPIs should not replace professional expert judgement; target values should be set only after baseline measurement and pilot validation using actual data. Keywords: management control, KPI, digital transformation, medicines, regulatory system, dashboard, Business Intelligence, process management, NCEMMD