Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China ()
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.
Share and Cite:
Zhao, Y. , Li, L. , Wang, X. and Chen, Y. (2021) Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China.
Pharmacology & Pharmacy,
12, 319-333. doi:
10.4236/pp.2021.1212027.
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