TITLE:
Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China
AUTHORS:
Yanjiao Zhao, Ling Li, Xinxin Wang, Yongfa Chen
KEYWORDS:
Drug Registration, Compliance Management, Compliance Program, Pharmaceutical Manufacturers
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.12 No.12,
December
28,
2021
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 forU.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.