China NMPA Letter of Authorization (LOA) Request Form
中国国家药品监督管理局: 药包材企业授权使用书申请表

For West to provide a Letter of Authorization (LOA) for your application of drug product registration to Center for Drug Evaluation (CDE), please complete West’s on-line LOA request form. Please enter your email address below and click "Next" to proceed to the request form. Please be sure that all information is complete and accurate. Questions marked (*) are mandatory. When you have finished filling out the form, click "Submit". A confirmation email will be sent to you upon successful submission.
如阁下为其药品制剂向药品审评中心(CDE)提出注册申请而需西氏提供药包材企业授权使用书(LOA), 请填妥西氏在线 LOA 申请表。请于下方输入您的电子邮件地址, 然后点击 "下一步" 进入申请表。请务必确定所填信息完整及正确,带有“*”标示的为必填项目 。当您完成填写表格后, 请点击 "提交"。成功提交后, 系统将向您发送确认电子邮件。

In general, your letter of authorization will be issued within 15 business days from the date of request via email. If the item requires an update to include the correct internal control strategy and compliance statement for the China market, your request will take approximately 10-15 weeks to process. To avoid any delay, we suggest you to plan ahead and apply for LOA at least four months prior to your application of drug product registration. If you are unsure whether your item requires an update or any other questions about an item update, please contact your Account Manager or Technical Customer Support.
一般情况下, 您的授权使用书将在收到申请之日起15个工作日内通过电子邮件发出。如果该产品需要更新以包含针对中国市场的正确内部控制策略和合规声明,您的申请办理时间则需大约 10-15 周。为避免任何延误,我们建议您提前计划并至少在药品注册申请前四个月提出授权使用书申请。如果您不确定您的商品是否需要更新或对产品更新有任何其他疑问,请联系您的客户经理或技术客户支持。

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Frequently Asked Questions

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