关键词: 新型冠状病毒肺炎, 药物警戒, 制度完善

Abstract: Objective To propose ways to improve China's pharmacovigilance system amid the COVID-19 epidemic. Methods Such methods as literature research were employed to study the applicability of the current pharmacovigilance system in China to the outbreak of COVID-19. Results During the COVID-19 pandemic, the current pharmacovigilance system could be weak in terms of ADR reporting, evaluation, communication and feedbacks. Conclusion The National Medical Products Administration (NMPA) needs to cooperate with the National Health Commission (NHC) to set up a collaborative working group on drug safety. An automated and intelligent data transmission channel should be established between the National Center for ADR Monitoring and medical institutions. A special reporting and feedback channel during the outbreak should be added to meet the needs of rapid collection of all suspected adverse drug reactions. Experts from research institutions should be invited to speed up the analysis and evaluation of adverse drug reactions. Also, risk communication methods and contents should be tailored for medical institutions and public media based on different goals.

Key words: COVID-19, pharmacovigilance, regulation improvement