Pharmacovigilance in China: current situation, successes and challenges
Li Zhang1, Lisa Y L Wong, Ying He
1Center for Drug Reevaluation, China Food and Drug Administration, Beijing, China.
Drug Safety
|September 15, 2014
Summary
China has established a comprehensive pharmacovigilance system, including the China Adverse Drug Reaction Monitoring System (CADRMS), to ensure medication safety. Further improvements in international data exchange and research are needed.
Area of Science:
- Pharmacovigilance
- Drug Safety Regulation
- Pharmaceutical Policy
Background:
- China's pharmaceutical economy and healthcare insurance system have undergone significant integration and transformation.
- A legislative framework for comprehensive drug regulation, from development to use, has been established by the China Food and Drug Administration (CFDA).
- A robust pharmacovigilance system, encompassing regulation, organization, and technology, was developed in China between 1989 and 2014.
Purpose of the Study:
- To describe the development and current status of China's pharmacovigilance system.
- To highlight the structure and data handling capabilities of the China Adverse Drug Reaction Monitoring System (CADRMS).
- To identify areas for improvement in China's drug safety monitoring and risk management.
Main Methods:
- Description of the four-level pharmacovigilance network (national, provincial, municipal, county) established by 2013.
- Utilization of the China Adverse Drug Reaction Monitoring System (CADRMS), an online spontaneous reporting platform.
- Analysis of data from over 6.6 million adverse drug reaction (ADR) case reports received by CADRMS by 2013.
Main Results:
- By 2013, China operated a four-level pharmacovigilance network with national, provincial, and municipal centers, supported by over 200,000 grassroots users.
- The CADRMS successfully collected over 6.6 million ADR case reports by 2013.
- The National Centre for ADR Monitoring (NCADRM) disseminates safety information and provides data feedback to manufacturers, while the CFDA employs risk management strategies.
Conclusions:
- China has built a comprehensive pharmacovigilance system, demonstrating significant progress in drug safety monitoring.
- Key areas for future development include enhancing international regulatory information exchange, signal generation, post-marketing pharmacoepidemiology research, and education.
- Continued refinement of the pharmacovigilance system is crucial for ensuring ongoing medication safety in China.
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