基于“5W模式”的中美药品橙皮书对比研究

doi:10.19803/j.1672-8629.2021.09.02

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (9): 806-809.
DOI: 10.19803/j.1672-8629.2021.09.02

基于“5W模式”的中美药品橙皮书对比研究

李逸云¹, 廖彩云^1,2, 潘静¹, 温宝书^1,*

¹国家药品监督管理局药品审评中心,北京 100020;
²中国药科大学,江苏南京 210000

收稿日期:2021-03-12 出版日期:2021-09-15 发布日期:2021-09-18
通讯作者: ^*温宝书,男,硕士,高级工程师,药品审评管理。E-mail：wenbsh@cde.org.cn
作者简介:李逸云,女,硕士,主管药师,药事管理。
基金资助:
重大新药创制国家科技重大专项2017年度 (2017ZX09101001-001-002）

A Comparative Study of Chinese and American Orange Books Based on the 5W Model

LI Yiyun¹, LIAO Caiyun^1,2, PAN Jing¹, WEN Baoshu^1,*

¹Center for Drug Evaluation, NMPA, Beijing 100020, China;
²China Pharmaceutical University, Nanjing Jiangsu 210000, China

Received:2021-03-12 Online:2021-09-15 Published:2021-09-18

摘要/Abstract

摘要： 目的基于传播学视角比较中美药品橙皮书异同,为中国药品橙皮书的发展提供思路。方法采用传播学领域经典理论模型—5W模式,将研究因素划分为传播者（who）、信息（says what）、媒介（in which channel）、受众（to whom）、传播效果（with what effect）,通过文献研究对中美药品橙皮书在各传播因素上的差异进行对比分析和研究。结果与美国药品橙皮书相比,中国药品橙皮书在管理机构、内容、发布渠道、受众以及取得的效果方面存在一定差距。结论建议结合我国药品监管实际,借鉴美国药品橙皮书有益经验,进一步完善中国药品橙皮书建设。

关键词: 药品橙皮书, 5W模式, 对比研究, 完善建议

Abstract: Objective To compare the similarities and differences between the Chinese and American Orange Books from the perspective of communication in order to contribute to the improvement of the Chinese Orange Book. Methods The 5W model, which was the classic theoretical model in the field of communication, was used. The related factors were divided into Who, Says What, In Which Channel, To Whom and with What Effect. Through literature research, the differences in various factors of communication between Chinese and American Orange Books were analyzed. Results There was some gap in management organizations, content, distribution channels, audience and effectiveness between the American Orange Book and the Chinese Orange Book. Conclusion It is recommended that the Chinese Orange Book be updated in line with the current drug supervision in China and by learning from the American Orange Book.

Key words: Orange Book, 5W model, comparative study, suggestions for improvement

中图分类号:

R954

李逸云, 廖彩云, 潘静, 温宝书. 基于“5W模式”的中美药品橙皮书对比研究[J]. 中国药物警戒, 2021, 18(9): 806-809.

LI Yiyun, LIAO Caiyun, PAN Jing, WEN Baoshu. A Comparative Study of Chinese and American Orange Books Based on the 5W Model[J]. Chinese Journal of Pharmacovigilance, 2021, 18(9): 806-809.

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基于“5W模式”的中美药品橙皮书对比研究

A Comparative Study of Chinese and American Orange Books Based on the 5W Model

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