Abstract: This paper is intended to analyze the difference in adverse reaction reporting and monitoring systems between the previous Drug Administration Law and the pharmacovigilance system specified in the newly revised Drug Administration Law. Starting with the meaning of pharmacovigilance and combined with the macro background of acceleration of new drug authorization since the reform of drug review and approval in China, this paper points out that the pharmacovigilance system can be compared to the braking mechanism for new drug review to enter the “expressway”. Combined with the transformation and application of ICH E2 series guidelines, this paper makes recommendations for the implementation of pharmacovigilance requirements according to the revised Drug Administration Law, such as changing notions about the monitoring and reporting of drugs, improving the efficiency and ability of signal detection, carrying out cumulative risk benefit evaluation, and exploring the requirements of risk management plans suited to China.

Key words: Drug Administration Law, pharmacovigilance, ICH E2, adverse event, risk management plan