Drug Safety Monitoring and Reporting Systems in China

Safety monitoring and reporting systems in China are complicated. There are many differences between China’s safety management systems and that of the West’s, making it harder for multinational companies to run their clinical trials and manage their marketed drugs. In this chapter, we will briefly review the history of safety-related regulations, current safety-monitoring regulations, and reporting requirements for the investigational drugs in the clinical development and marketing stages, as well as the perspectives of safety management in the future. The main contents are outlined as follows: Historic development of regulations for safety management, including the adverse drug reaction monitoring system and safety management regulations Safety management in clinical trials , including safety monitoring, reporting requirement and processes as well as the differences between China and western countries Safety management for post-marketing drugs and its regulations The roles of the CFDA in management of drug safety information, including the procedures of safety information collection, analysis and summary as well as drug risk control measures Considerations for global drug safety monitoring, reporting, evaluation and management in clinical trials