Abstract:

Objective： The purpose of this study is to evaluate the impact of the newly revised laws and regulations on the identification of counterfeit and substandard drugs by studying new definitions and regulations of counterfeit and substandard drugs in the newly revised judicial interpretation of the Supreme People's Court and the Supreme People's Procuratoratet on crimes endangering drug safety， the newly revised Drug Administration Law of the People's Republic of China and the Criminal Law Amendment （Ⅺ） of the People's Republic of China， and discuss their practical impact on the work of drug regulatory authorities in identifying falsified and substandard drugs.Methods： By systematically reviewing and analyzing the above laws and regulations， referring to relevant literature， consulting administrative law enforcement and drug testing experts， the impact of the newly revised laws and regulations on the identification of counterfeit and substandard drugs is analyzed， and a working model on the identification of counterfeit and substandard drugs is proposed， with the identification opinions issued by drug regulatory department as the core and drug testing based on the identification needs as the support.Results： The newly revised laws and regulations strictly stipulated the definitions and identification criteria for counterfeit and substandard drugs， put forward higher requirements for drug regulatory authorities. The proposed model for the identification of counterfeit and substandard drugs aims to strengthen the synergy between the regulatory authorities and testing organizations to ensure accurate and efficient identification， clarify the basic requirements for conducting tests on concerned drugs.Conclusion： The newly revised laws and regulations have profoundly affected the identification of counterfeit and substandard drugs. In order to adapt to the changes， drug regulatory authorities should actively explore and practice the new model of identifying counterfeit and substandard drugs， and at the same time， clarify the inspection requirements in order to ensure the scientificity and effectiveness of the identification of counterfeit and substandard drugs.

Key words:  , Judicial interpretation； , Counterfeit drugs； , Substandard drugs； , Crimes endangering drug safety