T/HENANPA 013-2024 Drug Adverse Event/Incident Association Evaluation Specification

Scope

Main technical content: This standard provides a reference basis for pharmaceutical marketing authorization holders and pharmaceutical manufacturers to analyze and evaluate adverse drug reactions/incidents reports and monitoring data, by setting out the principles and methods for evaluating the correlation between adverse drug reactions/incidents, as well as evaluation standards (there are six levels and 33 types of results for the evaluation of correlation). It also facilitates further drug safety research, the revision and improvement of drug product inserts, and the control of drug risks; it serves as a reference basis for pharmaceutical trading enterprises and medical institutions to analyze the collected adverse drug reactions/incidents reports and monitoring data, from which they can extract drug safety information requiring attention and take effective measures to reduce the risk of adverse drug reactions/incidents during drug use; it provides technical support for relevant government management departments at all levels to comprehensively analyze and evaluate the received adverse drug reactions/incidents reports, and further enhance the level of post-marketing risk management for drugs

Development Information

Related Standards