Establishing a scientific,efficient,and authoritative post-marketing drug regulatory system is an essential requirement for ensuring drug quality and safety.It is also a necessary step for China to transition from a major pharmaceutical country to a powerful one,better meeting the health needs of the population.This article summarizes the current progress in post-marketing drug regulation in China,analyzes emerging challenges and situations,expounds the inherent logic of effective post-marketing drug regulation,proposes future directions and tasks,and provides references for building a more scientific,efficient,and authoritative post-marketing drug regulatory system.
关键词
药品上市后监管/安全与发展/防范化解风险/药品监管能力建设
Key words
post-marketing drug regulation/safety and development/risk prevention and resolution/drug regulatory capacity-building