The Oretical Study on the Structure and Operation of the Pharmacovigilance System in Group Companies
10.3870/j.issn.1004-0781.2025.12.027
- VernacularTitle:集团公司药物警戒体系架构及运营的理论研究
- Author:
Yu MAO
1
;
Zhe HUANG
;
Wei ZHANG
;
Xinghua CHE
;
Hong GUO
;
Wei ZHANG
;
Jian GONG
Author Information
1. 沈阳药科大学,沈阳 110016;辽宁成大生物股份有限公司,沈阳 110179
- Publication Type:Journal Article
- Keywords:
Good pharmacovigilance practice;
Pharmacovigilance system;
Life cycle;
Group companies
- From:
Herald of Medicine
2025;44(12):2062-2068
- CountryChina
- Language:Chinese
-
Abstract:
The implementation of the Good Pharmacovigilance Practice(GVP)in 2021 has laid a solid foundation for improving China's pharmacovigilance system,a matter of paramount importance currently emphasized by Marketing Authorization Holders(MAHs).Given the unique organizational structures of corporate groups,establishing a centralized pharmacovigilance system can optimize resource utilization.This paper analyzes the challenges faced by corporate groups in developing such central-ized systems and proposes an organizational framework with defined operational divisions.The findings aim to provide actionable insights for vaccine manufacturers in establishing and refining life cycle pharmacovigilance systems.
