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Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China
The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing, China
The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing, China
The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing, China
The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing, China
- 1 The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing, China
- 2 The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing, China
- 3 The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing, China
- 4 The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing, China
Pharmacology & Pharmacy·Volume 12 (2021)·Pages 319–333·Published 6 December 2021·DOI10.4236/pp.2021.1212027
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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 regis tration 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.
KeywordsDrug RegistrationCompliance ManagementCompliance ProgramPharmaceutical Manufacturers
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