Brief Introduction of Pharmacovigilance System in the United States and Its Implication for China
10.3870/j.issn.1004-0781.2017.04.002
- VernacularTitle:美国药物警戒体系浅析及对我国的启示
- Author:
Tao WANG
;
Dan WANG
;
Duo DONG
;
Xue TANG
- Keywords:
Pharmacovigilance;
Institutional framework;
Regulation;
United States
- From:
Herald of Medicine
2017;36(4):361-365
- CountryChina
- Language:Chinese
-
Abstract:
Objective To make suggestions for China's drug safety supervision through an introduction of the status of pharmacovigilance system in the United States (US).Methods Through legal research and document research,the author introduced and analyzed the current situation of pharmacovigilance system in the US from the organization and responsibilities of Food and Drug Administration,system of laws and regulations,risk management and evaluation methods of post-marketing drugs etc.Results The US has now established a relatively mature pharmacovigilance system.This system has a perfect drug safety supervision organization structure,a sound system of laws and regulations and a scientific evaluation system of drug risk management.Conclusion The relevant experience of the US can be learned by China,such as the communication & collaboration between pre-and post-market drug regulatory agencies,instillation of drug risk management and establishment of guidance for industry to promote the development and improvement of China's drug safety supervision.
