欧盟药品防伪法律法规简介及启示

Introduction and Reference of EU′s Laws and Regulations on Drug Anti-Counterfeiting

假劣药品是药品市场最严重的问题之一,直接影响药品的安全、有效、可及,关乎全民的身体健康和生命安全。欧盟(EU)对于药品准入要求非常严格,2019年已全面实施欧盟防止假药进入合法供应链的指令,为欧盟广大患者提供药品安全保障。为防止假冒、劣质和有害的药品进入供应链,严格医药产品的安全措施,强化药品监管政策的推进和实施,加强对假劣药制售的惩处力度,本文从欧盟药品防伪体系建设出发,梳理欧盟药品防伪相关法律法规的推行策略,简要解读欧盟有关药品防伪政策有参考价值的内容,以期在已有实践经验的基础上,结合我国国情,借鉴欧盟经验,为加强我国药品防伪工作、完善科学,严格的制度建设提供先行借鉴。

Counterfeit drugs are one of the most serious problems in the drug market.It damages the safety,effectiveness and accessibility of drugs,and harms public health.The European Union(EU)has very strict rules on market entry of drugs.In 2019,the EU Falsified Medicines Directive(FMD)on preventing counterfeit drugs from entering the legal supply chain has been fully implemented to ensure drug safety for patients in the EU.In order to prevent counterfeit and substandard drugs from entering the market,it is vital to reinforce the safety measures.Implementation of relevant regulations and laws are very critical to strengthen the punishment for the manufacture and sale of counterfeit and substandard products.This paper summarized EU′s strategies of implementation of its drug anti-counterfeiting regulations and laws,which is from the aspase of its system construction,and briefly explained relevant contents in EU′s regulations as useful reference to us.In combination with practical situations in China market,we hope that with its existing implementation,EU′s experience could benefit us in facilitating the construction of our drug anti-counterfeiting system.