Zhao, Yanjiao and Li, Ling and Wang, Xinxin and Chen, Yongfa (2021) Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China. Pharmacology & Pharmacy, 12 (12). pp. 319-333. ISSN 2157-9423
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Abstract
In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management for U.S. pharmaceutical manufacturers as described in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug registration stages. Finally, some suggestions and implications are proposed to strengthen the construction of compliance management for Chinese drug registration applicants based on the former practical experience.
Item Type: | Article |
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Subjects: | South Asian Archive > Chemical Science |
Depositing User: | Unnamed user with email support@southasianarchive.com |
Date Deposited: | 29 Mar 2023 06:57 |
Last Modified: | 24 Jun 2024 05:13 |
URI: | http://article.journalrepositoryarticle.com/id/eprint/270 |