T/HENANPA 012-2024 National Drug Adverse Reaction Monitoring System Specification for Reporting Individual Case Information

Scope

Main technical content: This standard specifies the relevant terms and definitions of information in the national adverse drug reaction monitoring system, as well as the standard collection of information on individual adverse drug reactions/incident reports, the correct processing of information, the accurate filling out of information, and the standard reporting of information. It is applicable to the collection, processing, and standardized management of individual adverse drug reactions/incident reports in medical institutions at all levels. It provides guidance for medical institutions at all levels to improve the level of ADR/ADE monitoring and the quality of individual ADR/ADE reports, thereby effectively identifying and controlling drug risks

Development Information

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