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This application is a service of the Singapore Government.

Health Sciences Authority

Quality parameters for CPM products 产品质控指标资料

General Quality Parameters 产品的一般质控指标

It is mandatory for CPM applications to include the following information:


a) storage condition for imported products; or 进口产品的存贮条件
b) storage condition and container(s) for locally manufactured/assembled products; 本地生产或分装的产品的存贮条件及存贮容器
c) physical characteristics of the product such as colour, taste, smell, shape, size of capsule; and 产品外观描述,如颜色,味道,气味,形状,胶囊尺寸等
d) physical specifications of the product. 产品物理性状资料

Requirements (a) and (b) should be submitted using the relevant forms while requirements (c) and (d) could be included in the product's Certificate of Analysis (COA) or as separate document. The form is available during the submission of application.

以上 (a) 和 (b) 项资料请使用表格提交,(c) 和 (d) 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。

The shelf-life of a product is determined by the product formulation, packaging and storage conditions and the proposed shelf-life should be supported by evidence. CPM dealers must ensure the product remains stable and safe for use during the period of proposed shelf-life.


Requirements of Storage Condition / Containers 贮存条件/容器的要求

In the process of CPM listing application, the applicant is required to submit the form on Storage Condition of Chinese Proprietary Medicines (CPM).


The applicant will use either of the two forms, depending on the listing type of the product selected:


a) Imported products; and
b) Locally manufactured / assembled products.
本地生产 的/一级分装的中成药产品

Please refer to the following detailed description for more information on how to fill up the forms.


Download.IconPdfRequirements of Storage Condition/containers 贮存条件/容器的要求
File Size: (495 Kb)