2013年7月，美国食品药品监管局（FDA）发布了“说明书安全性变更——联邦食品、药品和化妆品法505（o）（4）节的实施”指导原则。介绍FDA主动要求变更药品说明书安全性资料的法规和实施办法，以期对丰富和创建我国相应的法规与指导原则、加强药政管理部门的依法监管、加速我国药品说明书安全性资料的更新提供有益的参考与启示。

FDA issued the Guidance for Industry Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act in July, 2013. This paper introduced the regulation and enforcement measures for safety labeling change initiatively requested by FDA. It is expected to provide the beneficial reference and enlightenment in order to enrich and create relevant laws and regulations and the guidelines of drug administration, enhance the custody of drug administration according to law, and accelerate the update of safety labeling changes in our country.