中国药物警戒 ›› 2021, Vol. 18 ›› Issue (9): 810-812.
DOI: 10.19803/j.1672-8629.2021.09.03

• 中国药品橙皮书专栏 • 上一篇    下一篇

我国药品橙皮书传播过程实证研究

廖彩云1,2, 李逸云2Δ, 姚文兵1,*, 温宝书2#   

  1. 1中国药科大学,江苏 南京 210000;
    2国家药品监督管理局药品审评中心,北京 100020
  • 收稿日期:2021-05-06 出版日期:2021-09-15 发布日期:2021-09-18
  • 通讯作者: *姚文兵,男,博士,教授,医药政策与法规研究等。E-mail：wbyao@cpu.edu.cn,#为共同通信作者。
  • 作者简介:廖彩云,女,硕士,药事管理与法规。Δ为并列第一作者。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017ZX09101001-001-002）

Dissemination Processes of the Chinese Orange Book: An Empirical Study

LIAO Caiyun1,2, LI Yiyun2Δ, YAO Wenbing1,*, WEN Baoshu2#   

  1. 1China Pharmaceutical University, Nanjing Jiangsu 210000, China;
    2Center for Drug Evaluation, NMPA, Beijing 100020, China
  • Received:2021-05-06 Online:2021-09-15 Published:2021-09-18

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摘要： 目的 探究我国医药行业相关人员对《中国上市药品目录集》（后更名为《新批准上市以及通过仿制药质量和疗效一致性评价的化学药品目录集》,简称“中国药品橙皮书”）传播过程的意见和建议,以分析中国药品橙皮书在发展中遇到的阻碍。方法 采用传播学领域经典理论模型—5W模式归纳研究因素并设计问卷,以药品监管机构、医药企业及相关学术机构为研究样本开展调研。结果 共得到了320份有效问卷,调研结果显示,中国药品橙皮书的传播过程有待完善。结论 结合数据分析,尝试基于传播者、传播内容、传播媒介以及受众层面提出完善中国药品橙皮书传播过程的政策建议。

关键词: 中国药品橙皮书, 传播过程, 5W模式, 问卷调查, 政策建议

Abstract: Objective To explore the feedback from professionals in Chinese pharmaceutical industry related to the dissemination process of the Chinese Orange Book and to analyze the obstacles to the implimentation of the Chinese Orange Book. Methods The 5W model, which is the classic theoretical model in the field of communication, was used to summarize the factors for research and design the questionnaire. Drug regulatory agencies, pharmaceutical manufacturers and related academic institutions were investigated as the subjects. Results A total of 320 valid questionnaires were collected and the survey data showed that the dissemination process of Chinese Orange Book needed to be improved. Conclusion Based on the data analysis, recommendations on how to improve the dissemination process of the Chinese Orange Book were offered from the perspective of disseminators, dissemination content, media and audience.

Key words: Chinese Orange Book, dissemination process, 5W model, questionnaire survey, policy recommendations

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