关键词: 药品上市许可持有人, 药物警戒体系

Abstract: In recent years, NMPA has accelerated the approval of drugs that are urgently needed and those for rare diseases and innovative treatment by reforming the drug review and approval system. This has gone a long way towards meeting the needs of Chinese patients for innovative drugs. At the same time, serious challenges are posed to drug safety risk monitoring in China. In 2018, NMPA issued a notice (No. 66) to enforce the legal responsibility of Marketing Authorization Holders (MAH) for reporting and monitoring of adverse drug reactions (ADR). Thus, pharmacovigilance by MAHs should be switched from the collection and analysis of individual cases to comprehensive and systematic safety evaluation and risk management of drugs. Pharmacovigilance is a trans-disciplinary science, compelling MAHs to effectively integrate the internal and external resources of the company and build a closely cooperative and coalition network of pharmacovigilance in order to better monitor and assess drug safety risks, fulfill the legal responsibility of the holders, and ensure the drug safety of patients.

Key words: Medicine Marketing Authorization Holder, pharmacovigilance system