Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (9): 806-809.
DOI: 10.19803/j.1672-8629.2021.09.02

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

LI Yiyun1, LIAO Caiyun1,2, PAN Jing1, WEN Baoshu1,*   

  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

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

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