Digital transformation handbook for reporting substandard and falsified medical products

Overview

The document outlines a structured approach to digital transformation, covering assessment of the current environment, stakeholder engagement, governance and policy alignment, definition of system requirements, implementation planning, and monitoring and evaluation. It emphasizes the transition from fragmented or paper-based reporting systems to interoperable digital platforms that improve data quality, standardization and timeliness. Drawing on global experience and existing WHO frameworks, the handbook promotes the use of user-centred design, open standards and integration with pharmacovigilance systems. It is intended for ministries of health, national regulatory authorities and partners seeking to strengthen reporting systems and enhance the capacity to detect and respond to substandard and falsified medical products.