美国药品供应链安全法及其启示

American Drug Supply Chain Security Act and its Enlightenment

2013年11月27日,美国国会通过的《药品供应链安全法》(Drug Supply Chain Security Act,DSCSA)明确规定,2014—2023年,美国将用10年时间建成覆盖全供应链的电子可互操作(interoperability)系统。规划以信息共享作为驱动核心,采取渐进式推进,实现对供应链中处方药的识别和追溯。法律明确了生产企业、再包装企业、药品经营批发企业、配送机构及第三方物流提供商在产品追溯、产品识别、产品验证与通知等方面的法律义务;建立了针对批发经营企业和第三方物流提供商的国家许可标准及其年报制度。电子可互操作系统的建立将实现处方药追溯的数字化,推动制药行业全流程的数字化和追溯相关技术新业态的发展,确保任何一方有能力避免有害药物进入供应链、侦测供应链中的有害药物并快速做出反应。美国的做法对我国正在推进的产品追溯工作具有一定借鉴意义。本文将系统介绍《药品供应链安全法》内容立法、实施中面临的挑战与启示,以期为我国开展相关工作、提升监管科学性提供参考和思路。

The Drug Supply Chain Security Act(DSCSA)was enacted by U.S Congress on November 27,2013.The DSCSA outlines steps over a-10 years,2014-2023,to build an electronic,interoperability system to identify and trace certain prescription drugs as they are distributed in the United States.Driving by information sharing,the ACT clarifies the requirements for manufacturers,repackagers,wholesale distributors,dispensers,and third-party logistics providers in product tracing,identification,verification and notification,etc.Additionally,the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers,and requires these entities report licensure and other information to FDA annually.The electronic interoperability system will digitize product tracking and facilitate the new horizons in digitalization and trace-and-track all along the pharmaceutical industy to ensure the capability to prevent harmful drugs from entering the supply chain,detect harmful drugs if they do enter the supply chain,and enable rapid response when such drugs are found.This article overviews the DSCSA,the challenges and enlightenments in its implementation,in order to put reference to improve drug regulation scientifically.