Thoughts on the Establishment of Pharmacovigilance System for Marketing Authorization Holders(MAHs)

doi:10.19803/j.1672-8629.2020.08.06

Abstract

Abstract: Objective To provide reference for the development and supervision of pharmacovigilance by introducing the establishment of MAH pharmacovigilance systems and related considerations. Methods In combination with laws and regulations as well as the actual situation of enterprises, we summarized and analyzed the status quo of and problems with pharmacovigilance, and presented our views. Results It's necessary and urgent for MAHs to establish pharmacovigilance that is of great significance for the safety of patients and businesses. Conclusion It is vital for MAHs to speed up the establishment of a sound pharmacovigilance system in order to make pharmacovigilance more effective.

Key words: marketing authorization holder, drug, pharmacovigilance system, establishment

CLC Number:

R994

CHEN Cancan, CHEN Wei, ZHANG Yanan, HU Xiaoguang, LI Wanjun. Thoughts on the Establishment of Pharmacovigilance System for Marketing Authorization Holders(MAHs)[J]. Chinese Journal of Pharmacovigilance, 2020, 17(8): 474-479.

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