National ADR Monitoring System in China

• Published in: Drug safety Vol. 39; no. 11; pp. 1043 - 1051
• Main Authors: Hou, Yongfang, Li, Xinling, Wu, Guizhi, Ye, Xiaofei
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.11.2016; Springer Nature B.V
• Subjects: Adverse Drug Reaction Reporting Systems - legislation & jurisprudence; Adverse Drug Reaction Reporting Systems - organization & administration; China; Conflicts of interest; Consumer protection; Data dictionaries; Drug Safety and Pharmacovigilance; Drugs; Funding; Humans; Information management; Labeling; Medicine; Medicine & Public Health; Pharmaceutical industry; Pharmacology/Toxicology; Reporting requirements; Review Article; Side effects; China; China, People's Rep; Provincial Center; Adverse Drug Reaction; Monitoring Agency; Adverse Drug Reaction Report; Causality Assessment
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-016-0446-5

It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstrate how individual case safety reports (ICSRs) are reported and evaluated and how data quality control is achieved in China. We also aimed to discuss the present status and future of NADRMS. We reviewed the relevant regulations and literature around ADR reporting in China. ADR report collection tools in China have gone through three phases, namely paper-based reporting, software-based reporting using standalone computers, and online reporting. Nowadays the online reporting system plays an important role in China and the number of ADR reports has rapidly increased. NADRMS is similar to most of the ADR reporting systems around the world, but also has its own unique characteristics such as four levels of monitoring agencies. In summary, there is still a long way to go for China to establish a high-level ADR monitoring system to ensure drug safety.