中国药物警戒 ›› 2021, Vol. 18 ›› Issue (3): 245-249.
DOI: 10.19803/j.1672-8629.2021.03.08

• 法规与管理研究 • 上一篇    下一篇

处方药说明书中安全性信息管理要求的国内外对比与启示

丛端端1, 薛薇1, 刘岳1, 齐文渊1, 刘晓慧1, 王娟1, 李可欣1, 胡欣2,*   

  1. 1北京医院临床试验研究中心,国家老年医学中心,中国医学科学院老年医学研究院, 北京 100730;
    2北京医院药学部,药物临床风险与个体化应用评价北京市重点实验室,国家老年医学中心,中国医学科学院老年医学研究院,北京 100730
  • 出版日期:2021-03-15 发布日期:2021-04-06
  • 通讯作者: *胡欣,男,主任药师,教授·博导,临床药理、临床药学研究和医疗机构药事管理。E-mail: huxinbjyy@126.com
  • 作者简介:丛端端,女,博士,医师,药物临床试验医学监护。
  • 基金资助:
    “国家重大新药创制”科技重大专项（项目编号：2017zx09101001002002）

Management of Safety Information in Prescription Drug Labeling in China, Japan and the United States

CONG Duanduan1, XUE Wei1, LIU Yue1, QI Wenyuan1, LIU Xiaohui1, WANG Juan1, LI Kexin1, HU Xin2,*   

  1. 1Clinical trial Centre, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China;
    2Department of Pharmacy, Assessment of Clinical Drugs Risk and Individual Application Key Laboratory, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
  • Online:2021-03-15 Published:2021-04-06

PDF (PC)

339

摘要： 目的 为我国处方药说明书中安全性信息的管理提供参考。方法 通过查阅法规和文献,分析和对比中国、美国及日本的处方药说明书中安全性信息的格式要求和修订流程。结果 相比美国和日本,我国法规和指南对处方药说明书中安全性信息相关项目的撰写要求描述较简单,执行上灵活性过大;处方药说明书的修订流程和修订后告知在执行和落实上仍然缺乏足够的细节依据。结论 建议结合他国经验,征求国内外专家意见,以《药品说明书和标签管理规定》及其细则公开征求修订意见为契机,进一步完善处方药说明书安全性信息管理要求。

关键词: 处方药, 说明书, 安全性信息, 修订

Abstract: Objective To provide references for the management of safety information in prescription drug labeling in China. Methods By consulting regulations and literatures, format requirements and revision procedures of safety information in prescription drug labeling were compared among China, the United States and Japan. Results Compared with the United States and Japan, content and format requirements in Chinese regulations and guidelines for the safety-concerning sections of prescription drug labeling were relatively brief,and the implementation was too flexible. The revision process and notification after revision lack detailed basis for implementation. Conclusion It is suggested that both foreign and domestic experts should be widely consulted in combination with the experience of other countries. The safety information management system of the labeling could be further improved based on a comprehensive revision of the“Provisions on the Administration of Pharmaceutical Directions and Labels”and its detailed rules.

Key words: prescription drugs, labeling, safety information, revision

中图分类号: