药品制剂中所用原料药产地变更关键问题探讨  

Discussion of key issues on the origin change of APIs used in pharmaceutical preparations

作　　者：史继峰[1] 王亚敏[1] 刘璐[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2014年第8期944-947,共4页Chinese Journal of New Drugs

摘　　要：药品制剂所用原料药的产地变更是药品上市后变更的一种常见情形。鉴于原料药质量与制剂质量直接相关,而原料药产地的变更可能对自身质量产生不利影响,进而影响制剂的最终质量,因此这种变更实际是较大的一种变更,必须进行充分的研究和验证。美国、欧盟以及我国药品管理机构均发布了原料药产地变更的指导原则。本文根据指导原则要求并结合审评工作实际,阐述了药品制剂所用原料药产地变更研究中应关注的重点问题,供研究参考。The origin change of APIs used in pharmaceutical preparations is very common after the drug approved. Since the quality of APIs is directly related to the quality of the pharmaceutical preparations, the origin of APIs may adversely affect the quality of their own, thereby affecting the quality of the final formulation. Thus, this change is actually a larger change and must be adequately studied and verified. U.S. , EU and China＇s drug regulatory agencies have issued guidelines about APIs＇ origin change. In this paper, combined with the guiding principles and the actual review practice, we elaborated the key issues about the research related to origin change of APIs used in pharmaceutical preparations.

关 键 词：药品制剂 原料药产地变更 关键问题 

分 类 号：R95[医药卫生—药学]