2019年8月，國(guó)家藥品監(jiān)督管理局頒布了《藥品質(zhì)量抽查檢驗(yàn)管理辦法》，同時(shí)廢止了2006年7月頒布的《藥品質(zhì)量抽查檢驗(yàn)管理規(guī)定》，對(duì)中國(guó)藥品上市后質(zhì)量抽查檢驗(yàn)和質(zhì)量評(píng)價(jià)提出了新要求。《藥品質(zhì)量抽查檢驗(yàn)管理辦法》針對(duì)當(dāng)前及未來的監(jiān)管形勢(shì)，新增或修訂了組織管理、抽檢計(jì)劃、樣品抽取、檢驗(yàn)復(fù)驗(yàn)、監(jiān)督管理、信息公開各環(huán)節(jié)的諸多內(nèi)容，對(duì)打擊假劣藥品和挖掘潛在質(zhì)量安全風(fēng)險(xiǎn)具有重要意義，建議相關(guān)工作人員予以重視并落實(shí)到位。

In August 2019, the National Medical Products Administration issued the "Regulations on Drug Quality Sampling and Testing", and abolished the version issued in July 2006, making new requirements for post-market quality sampling and testing and quality evaluation of drugs in China. In view of the current and future regulatory situation, this version has added or revised many contents of organizational management, planning, sampling, testing and re-testing, supervision, and information disclosure, etc, which is of great value in combating counterfeit and substandard drugs and preventing and controlling potential quality and safety risks, and it is recommended that relevant staff members pay attention and implement it in place.

R951;R926