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Pharmacovigilance in China: development and challenges.

Ying Zhao^1,2, Tiansheng Wang³, Guangyao Li^2,4

¹Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China.

International Journal of Clinical Pharmacy

|July 28, 2018

Summary

China

Keywords:

Adverse drug reactions China Drug safety Pharmacovigilance Post-marketing monitoring

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Area of Science:

Pharmacovigilance and Drug Safety
Public Health Policy
Pharmaceutical Regulation

Background:

Growing concerns regarding rational drug use and drug safety in China.
Increased public access to medications necessitates robust pharmacovigilance systems.
The evolution of pharmacovigilance in China over the past three decades.

Purpose of the Study:

To introduce China's pharmacovigilance system.
To outline its development, utilization, and challenges.
To provide an overview of regulatory frameworks and monitoring programs.

Main Methods:

Literature search for relevant studies on pharmacovigilance in China.
Synthesis of extracted data to describe system evolution and components.
Analysis of laws, regulations, and monitoring systems.

Main Results:

China's pharmacovigilance system has developed over 30 years, with four administrative levels.
Over 20 laws and regulations support drug safety from development to use.
An online Adverse Drug Reaction (ADR) Monitoring System exists, with ongoing development of active surveillance programs.

Conclusions:

Significant progress has been made in ADR monitoring and pharmacovigilance in China.
Further development of the system and strengthening of laws and regulations are crucial.
Enhancing the safe use of medicines remains a key objective.