美国FDA新颁发政策与程序手册——“对基于问题审评的申报资料的药学审评”的分析解读

Analysis and Interpretation of Newly Issued FDA Manual of Policies and Procedures——“Chemistry Review of QbR Submissions”

对美国FDA于2014年11月18日发布的政策与程序手册"对基于问题审评的申报资料的药学审评"进行介绍与讨论,包括发布该手册的目的、背景、采用基于问题的药学审评的优势、相关政策、各自职责与程序等,以及原文附件中与原料药及制剂申报相关的技术问题,以便于药学工作者了解与药学审评相关的问题的全貌。

This paper focused on a brief introduction of FDA MAPP ＂Chemistry Review of QbR Submissions＂issued on November 18th 2014, including the purpose and background of the issuance, benefits of the QbR approach, relevant policies, respective responsibilities and procedures. In addition, all the QbR questions relating to drug substance and drug product in the MAPP were included to provide readers with a full view of the QbR questions.