With effect from 15 July 2010, it is mandatory for new CPM applications to include the following information:
从2010年7月15日起,中成药产品的申请将必须提交以下资料 :
a. storage condition 存贮条件
b. storage container(s) 存贮容器
c. physical characteristics of the product such as colour, taste, smell, shape, size of capsule 产品外观描述,如颜色,味道,气味,形状,胶囊尺寸等
d. batch number of product in certificate of analysis (COA) 检验报告需列出产品的批号
Requirements (a) and (b) should be submitted using the form (Storage condition and container(s) of CPM – Locally manufactured / assembled products or Storage condition of CPM – Imported products) while requirement (c) could be included in the product's COA or as separate document. The form is available during the submission of application.
以上 a 和 b 项资料请使用“中成药产品的贮存条件和贮存容器 - 适用于本地生产的/一级分装的中成药产品”或“中成药产品的贮存条件 - 适用于进口的中成药产品”表格提交,c 项资料可包括在产品的检验报告中或是另附文件提交。表格可在提交产品电子申请时下载。
For new CPM applications, applicant is encouraged to voluntarily submit the following information on physical specification of the products:
申请者也可在提出中成药产品申请时,自愿呈交以下有关产品物理性状资料:


