Abstract: In September 2018, the National Medical Products Administration issued a notice on the Direct Reporting of Adverse Drug Reactions(ADRs) by Marketing Authorization Holders(MAH). The Notice aims to enforce the legal responsibility of MAH for ADRs reporting and monitoring, and strengthen the whole life cycle management of drugs. This paper analyzed the background of the announcement, interpreted the core content of the notice, including the requirements of the ADRs monitoring system, the ADRs collection and reporting, analysis and evaluation, risk control and other provisions, and clarified the connotation and significance of establishing System of ADRs Direct Reporting.

Key words: ADR monitoring, ADR Direct Reporting System, exoplore