Comparative Study on Pharmacovigilance Signal Management System among the European Union ，the United States and Japan
- VernacularTitle:欧盟、美国和日本的药物警戒信号管理体系比较研究
- Author:
Wenhui SHI
1
;
Lei BA
1
;
Jian ZHOU
1
;
Jie YAO
1
;
Xuening ZHANG
1
;
Guanrong WANG
1
;
Xiaoyan TAN
1
;
Zhiming SUN
1
Author Information
1. Jiangsu Health Development Research Center，Nanjing 210036，China
- Publication Type:Journal Article
- Keywords:
European Union;
The United States;
Japan;
Pharmacovigilance;
Signal;
Active surveillance;
Data mining;
En-
- From:
China Pharmacy
2021;32(4):406-412
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union （EU），the United States （U. S. ）and Japan. METHODS：Literature analysis method was used to systematically compare the similarities and differences on definitions ，sources， detection methods and management process of pharmacovigilance signals among EU ，U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS ：Regulatory authorities of the EU ，U. S. and Japan did not have a uniform definition on signals ；EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ，FDA adopted its own definition ，while the Japanese regulatory agency had no clear definition. Currently ，post-marketing surveillance still relied mainly on spontaneous reporting systems ；EU，U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ；EU mainly adopted the proportional reporting ratio method ，U. S. mainly adopts the multiple gamma Poisson Shrinker ，and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ，while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ，draw up guidelines on pharmacovigilance practices ， strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ，for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.
