Post-marketing PV in China

Post-marketing pharmacovigilance (PV) refers to the collection, monitoring, assessment, and reporting of adverse drug reactions (ADRs) that occur after a drug has been approved and marketed for use in the general population. Post-marketing PV activities are carried out by regulatory authorities, pharmaceutical companies, and healthcare professionals to ensure that drugs remain safe for use in the general population. The ultimate goal of post-marketing PV is to identify and minimize the risks associated with the use of medicinal products, thereby ensuring the safety and well-being of patients.
ADR Monitoring Network in China and Main Responsible Competent Authority
China’s drug adverse reaction monitoring network is divided into four levels, including the National Centre for Drug Re-evaluation (CDR), 34 provincial drug adverse reaction monitoring centres, and hundreds of municipal and county-level institutions responsible for adverse drug reaction monitoring.1 These institutions monitor and evaluate medical device-related adverse events, cosmetic adverse reactions, and drug abuse, in addition to adverse drug reactions. The role of China’s adverse drug reaction monitoring agencies has gradually been shifted to pharmacovigilance management.
At present, CADRMS incorporates a direct reporting system for ADRs for MAHs, a reporting system for ADRs for medical institutions and enterprises, a monitoring system for medical device-related adverse events, a monitoring system for adverse cosmetic reactions and a reporting system for drug abuse.2 In addition, CADRMS has functional modules for data analyses, signal detection, potential alert management and periodic safety update report management.3 In recent years, CDR has explored and constructed an active monitoring system for drug safety based on electronic medical records from medical institutions.
In 2010, the Ministry of Health and the National Medical Products Administration formulated the National Guideline for the Surveillance of Suspected Adverse Events following Immunization, which clearly outlines the reporting requirements for Adverse Events Following Immunization (AEFI) for post-approval vaccines. According to this guideline, responsible reporting units and reporters are required to report suspected AEFI to their local county-level Centre for Disease Control and Prevention agency where the vaccine recipients reside.4 China has gradually established and enhanced its AEFI monitoring information management system, and the AEFI case reporting network was completed on a national level in 2008.5 The Chinese Centres for Disease Control and Prevention established the AEFI Monitoring System, which shares information with the Drug Adverse Reaction Monitoring Agency.
1. Zhao Y, Wang TS, Li GY, Sun S. Pharmacovigilance in China: Develop- ment and challenges. Int J Clin Pharmacol. 2018;40(4):823-831.
2. National Center for ADR Monitoring of China. The Chinese Adverse Drug Reaction Monitoring System. Available at
3. Song HB, Shen C. Thoughts on the use of electronic health data in the safety research of marketed drugs. China Food Drug Administrat Mag. 2020;36-47.
4. National Surveillance Program for Suspected Abnormal Response of Vaccination. Chin J Vacc Immun. 2011;17:72-81.
5. Liu DW, Wu WD, Li KL, et al. Surveillance of adverse events following immunization in China: Past, present, and future. Vaccine. 2015; 33(32):4041-4046.
Should you have any queries or seeking for consultation, please contact us via online chat or email.