对药品国际注册中菌种问题的探讨

Discussion of the Strain Problems in Drug International Registration

以欧盟和美国FDA等国家药政发布的法规和指南为依据,探讨申请文件中关于被申请药品(发酵原料药)菌种的相关信息(如菌种的来源、细胞库、鉴定、纯度和稳定性)。

In accordance with EDQM and FDA or the other organization issued the rule and guidance,discusse the strain information of the drug to be registered（API manufactured by fermentation） from these items： origin,cell banking,tests of identity,tests of purity and stability.