| 摘要: |
| 说明书是患者选择和使用药品、医师处方以及药师调配药品的依据，对指导临床用药具有重要作用。修订药品说明书是药物全生命周期管理的重要内容。本文结合审评工作，着重探讨了已上市中药说明书安全性内容修订中的技术要求和常见问题。常见问题包括未提示重要的安全性风险、变相扩大功能主治、支持数据不充分和撰写表述不规范等。相关内容为上市许可持有人加强上市后中药安全性研究与评价，完善已上市中药说明书安全性内容提供参考。 |
| 关键词: 中药 说明书 安全性内容 修订 |
| DOI：10.11656/j.issn.1672-1519.2023.01.13 |
| 分类号:R286 |
| 基金项目: |
|
| Requirements in the revision of the safety content of marketed traditional Chinese medicine labeling |
|
AN Na, WANG Qingli, ZHOU Bei
|
|
Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
|
| Abstract: |
| Labeling is the basis to choose and use medicine for patients,to prescribe medicine for physician,and to dispense medicine for pharmacists. Labeling also plays an important role in guiding clinical medication. It is important to revise labeling in the pharmaceutical product lifecycle management. Combined with the drug review,this paper focuses on the technical requirements and common issues in the revision of the safety content of marketed traditional Chinese medicines labeling. Common issues include failure to prompt important safety risks,expansion of indications,insufficient supporting data,and irregular writing. Relevant content provides reference for marketing authorization holders to strengthen the safety research and evaluation of marketed traditional Chinese medicines,and to improve the safety content in labeling. |
| Key words: traditional Chinese medicine labeling safety contents revision |
