Dear Customer / 尊敬的客户，

The requested LOA is only applicable to the submission in China.

本页面申请的授权使用书仅限中国申报使用。

Please fill out a separate LOA request form for each drug product application. The color scan

copies of the requested LOA(s) will be sent to you by E-Mail.

请为每一份需要注册申报的制剂填写一份授权使用书申请表。授权使用书彩色扫描件会通

过电子邮件寄送。

The LOA provides authorization to the Center for Drug Evaluation (CDE), NMPA to review SG files

in parallel with the Marketing Authorization Holder (MAH) application. Upon receiving your

request, SG will prepare the LOA. The signed LOA scan copy will be sent to the designated

recipient’s email within 7 working days.

授权使用书授权药品审评中心（CDE）在审查制剂申请时关联审评 SG 提交的资料。收到您

的需求后，SG 将为您准备授权使用书。授权使用书扫描件将在 7个工作日内发送到指定

收件人的电子邮箱。

Note / 注：

1. Chinese is the official language of the LOA.

中文是授权使用书的官方语言。

2．Effective 02 July 2020, CDE authorized the use of copies of a Letter of Authorization (LOA)

as acceptable for drug filings. Therefore, the original hard copies of the LOA normally will

not be mailed.

自 2020 年 07 月 02 日起，CDE 已批准使用药包材授权书复印件进行制剂申报。

因此，签署的授权使用书纸质版原件通常不再寄出。

3. * = Required fields / 必填项