2019年8月，國家藥品監(jiān)督管理局頒布了《藥品質量抽查檢驗管理辦法》，同時廢止了2006年7月頒布的《藥品質量抽查檢驗管理規(guī)定》，對中國藥品上市后質量抽查檢驗和質量評價提出了新要求?！端幤焚|量抽查檢驗管理辦法》針對當前及未來的監(jiān)管形勢，新增或修訂了組織管理、抽檢計劃、樣品抽取、檢驗復驗、監(jiān)督管理、信息公開各環(huán)節(jié)的諸多內容，對打擊假劣藥品和挖掘潛在質量安全風險具有重要意義，建議相關工作人員予以重視并落實到位。

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