Xin Sun and colleagues discuss the development of real world evidence in Chinese healthcare and propose strategies to improve its quality and usefulness

Not only has the national online SRS system provided a platform for passive pharmacovigilance, it has also become an important platform for various explorations of active pharmacovigilance in China. Quick reporting and intelligent scanning of ADRs, facilitated by automated ADR detection based on electronic hospital records, have accelerated to capabilities for active pharmacovigilance. The outcomes of the programs, such as the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program, usher in a new era for China's active pharmacovigilance. These are particularly important to bridge the information system of sentinel hospitals and ADR research centers, but gaps remain. Thus, much work needs to be done before a high-level active pharmacovigilance system is sufficiently mature to ensure drug safety in the country.

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.