目的：本研究旨在梳理新修订的最高人民法院 最高人民检察院关于危害药品安全犯罪司法解释、新修订《中华人民共和国药品管理法》和《中华人民共和国刑法修正案（十一）》中涉及假劣药定义与认定的具体内容，通过综合分析新法规的变化，探讨其对药品监管部门在假劣药认定工作中的实际影响。方法：通过系统回顾与分析上述法律法规，参考相关文献资料，并咨询行政执法和检验技术专家，分析新法规对药品监管部门开展假劣药认定工作的影响，研究提出以药品监管部门出具认定意见为核心，以基于认定需要的药品检验为支撑的假劣药认定工作模式。结果：新法规对假劣药定义与认定标准进行了严格规定，对药品监管部门提出更高要求。提出的假劣药认定工作模式旨在强化监管部门与检验机构的协同作用，确保认定准确高效，明确药品检验机构开展假劣药检验的基本要求。结论：新修订的法律法规深刻影响假劣药认定工作。为适应变化，药品监管部门应积极探索并实践新的假劣药认定工作模式，同时明确检验要求，以确保假劣药认定工作的科学性和有效性。

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.