2013年7月，美國食品藥品監(jiān)管局（FDA）發(fā)布了“說明書安全性變更——聯(lián)邦食品、藥品和化妝品法505（o）（4）節(jié)的實施”指導(dǎo)原則。介紹FDA主動要求變更藥品說明書安全性資料的法規(guī)和實施辦法，以期對豐富和創(chuàng)建我國相應(yīng)的法規(guī)與指導(dǎo)原則、加強(qiáng)藥政管理部門的依法監(jiān)管、加速我國藥品說明書安全性資料的更新提供有益的參考與啟示。

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.