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Perspectives on Neuroscience

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Active pharmacovigilance in China: recent development and future perspectives.

Xinling Li¹, Haona Li^2,3, Jianxiong Deng⁴

¹Center for Drug Reevaluation, China Food and Drug Administration, Beijing, China.

European Journal of Clinical Pharmacology

|April 12, 2018

Summary

China

Keywords:

Active pharmacovigilance Data partner cooperation Drug safety Spontaneous reporting system

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Area of Science:

Pharmacovigilance
Drug Safety
Public Health

Background:

Active pharmacovigilance effectiveness relies on adopted methods and work patterns.
China has increasingly focused on implementing active pharmacovigilance systems.
Evaluation of current implementation and future needs in China remains limited.

Purpose of the Study:

To review China's recent active pharmacovigilance approaches.
To assess the current state and identify future needs of these systems in China.

Main Methods:

Review of scientific articles and regulatory agency websites (China Food and Drug Administration, China National Center for Adverse Drug Reaction Monitoring).
Analysis of information on China's spontaneous reporting systems (SRS) and active pharmacovigilance system.
Examination of annual and internal reports on pharmacovigilance in China.

Main Results:

Improvements in quicker adverse drug reaction (ADR) reporting and intelligent scanning methods.
Utilization of pharmacovigilance to mine electronic hospital records for ADR detection.
Development of integrated systems like the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program.

Conclusions:

China's national SRS is a platform for both passive and active pharmacovigilance.
Automated ADR detection using electronic health records enhances active pharmacovigilance capabilities.
While advancements are noted, further development is required for a mature, high-level active pharmacovigilance system to ensure national drug safety.