关键词: 化学药品, 药品说明书, 上市后, 安全性信息, 修订, 药品不良反应

Abstract: Objective To lay out the considerations for post-marketing revision of safety information in the instructions of chemical drugs, and provide a reference for drug marketing authorization holders and regulatory agencies. Methods Based on experiences related to revision of safety information in package inserts for chemical drugs, the priorities for collecting and analyzing safety information in package inserts were described, and the key points for writing the revised information related to warnings, adverse reactions, contraindications and precautions were summarized. Results and Conclusion Safety information needs to be revised all the time to dynamically reflect the risk-benefit balance of chemical drugs. Regulatory agencies should specify the working procedures and key points of the post-marketing revision of package inserts for chemical drugs while marketing authorization holders should promptly and proactively fulfill their responsibility of revising the safety information in drug instructions after marketing to ensure the safety of drugs.

Key words: Chemical Drugs, Instructions, Post-Market, Safety Information, Revision, Adverse Drug Reactions