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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 new CPM applications to include the following information:

中成药产品的申请必须提交以下资料:

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; and 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. 产品外观描述,如颜色,味道,气味,形状,胶囊尺寸等

Requirements (a) and (b) should be submitted using the relevant forms 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:

Download.IconPdfPhysical specifications for CPM products 产品物理性状资料
File Size: (215 Kb)

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.

中成药的有效期是由其处方组成,包装材料和贮存条件所决定的,有效期的设定须有相关证据支持。中成药业者必须确保其产品在有效期内保持稳定并能安全使用。

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).

在中成药产品申请时,申请人需要提交有关产品贮存条件及贮存容器的声明表格。

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

依据所申请产品的类型,表格分为下列两种专用表格,申请人需要明确所申请的产品类型,然后选择合适的表格进行填写:

a) Imported products (CPMF 13.3a); and
进口的中成药产品 (CPMF 13.3a);以及
b) Locally manufactured / assembled products (CPMF 13.2b).
本地生产 的/一级分装的中成药产品 (CPMF 13.2b)

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

请参照以下有关表格填写的详细说明,填写表格中相应的各个选项。

Download.IconPdfRequirements of Storage Condition/containers 贮存条件/容器的要求
File Size: (473 Kb)

Updated Dec16