新版《药品召回管理办法》施行下的执行要求及建议

Implementation requirements and recommendations under the implementation of the new administrative measures for drug recalls

新版《药品召回管理办法》(简称新《办法》)于2022年11月1日实施。本文从执行层面出发,结合相关上位法辨识各市场主体的责任,结合相关文献提及的召回实践中常见的问题对新《办法》执行要求进行分析并给出执行建议。各市场主体应主动承担起相应的职责,做好配合,共同践行保障公众用药安全的社会责任。

The new version of the Measures for the Administration of Drug Recall(the new Measures)was implemented on 1 November 2022.This paper analyses the implementation requirements of the new Measures from the perspective of implementation,identifies the responsibilities of each market entity in accordance with the relevant higher-level laws,and analyses the common problems in the recall practice as mentioned in the relevant literature and gives suggestions for the implementation of the new Measures.All market entities should take the initiative to assume the corresponding responsibilities,do a good job in co-operation,and jointly practice the social responsibility of safeguarding public drug safety.