合格药品在正常用法用量下出现的与用药目的无关的有害反应。属于药物安全性监测的重要概念，包括副作用、毒性反应、过敏反应等类型，需要严格的报告和监测体系进行管理和控制。
| 标准号 & 类别 | 标准名称 | 发布 |
|---|---|---|
| DB13/T 5482-2022 规范 |
Guidelines for rapid reporting of adverse drug reactions
|
2022-02-28 河北省标准 |
| DB13/T 6072-2025 规范 |
Technical Specifications for Pharmacovigilance in Medical Institutions
|
2025-04-03 河北省标准 |
| DB1306/T 266-2024 规范 |
Guidelines for filling out adverse drug reaction reports
医疗机构 |
2024-09-09 河北省标准 |
| DB14/T 3469-2025 规范标准 |
Guidelines for the Handling of Serious Adverse Drug Reaction Events by Marketing Authorization Holders of Medicinal Products
|
2025-07-10 山西省标准 |
| DB3713/T 316-2024 规范 |
Norms for the Monitoring of Adverse Drug Reactions in Medical Institutions
医疗机构 药品 |
2024-08-07 山东省地方标准 |
| DB41/T 2319-2022 规范标准 |
Standards for reporting and monitoring of adverse drug reactions in medical institutions
医疗机构 |
2022-09-16 河南省标准 |
| DB4114/T 223-2024 术语 |
Guidelines for Adverse Drug Reaction Monitoring
|
2024-08-09 河南省标准 |
| DB4403/T 526-2024 规范 |
Technical Specifications for Monitoring and Reporting Adverse Drug Reactions in Medical Institutions
医疗机构 |
2024-11-15 广东省标准 |
| T/CACM 014-2016 规范 |
Technical specification for hospital centralized monitoring of post-marketing safety of Chinese patent medicines
中成药 |
2016-12-27 中国团体标准 |
| T/CACM 1370.2-2021 规范标准 |
Technical Specifications for the Revision of Safety Information in the Marketed Chinese Patent Medicine Instructions—Adverse Drug Reactions
中成药 |
2021-07-23 中国团体标准 |
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