Abstract: Objective To provide suggestions for safety monitoring of new drugs after marketing. Methods By consulting literature, databases and drug instructions, the indications, adverse reactions and safety risk factors of 50 new drugs in 2018 were analyzed. Results The accelerated approval of new drugs and insufficient exposure to potential risks posed severe challenges to post-marketing safety monitoring. Conclusion New drug Marketing Authorization Holders(MAH), medical institutions, monitoring agencies and regulatory authorities should fulfill the duty of notice on the Direct Reporting of Adverse Drug Reactions(ADRs) and actively carry out post-marketing risk monitoring of new drugs.

Key words: new drug, Marketing Authorization Holders(MAH), Direct Reporting of Adverse Drug Reactions