Abstract: Objective To explore the challenges to pharmacovigilance by medical institutions under the new Drug Administration Law. Methods Literature analysis and comprehensive analysis were conducted for the discussion. Results Medical institutions lacked the ability to find and evaluate the potential risks to drug safety, showed poor initiative for pharmacovigilance, and were understaffed. Conclusion It is recommended that a complete hospital pharmacovigilance system be established, related training be improved, and social forces be given full play to in order to promote pharmacovigilance by medical institutions.

Key words: Drug Administration Law, pharmacovigilance, medical institutions, challenge