The procedure for Import Drug NMPA Registration

◄ The procedure for Import Drug NMPA Registration ►

Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |

In brief, if your products need not to be conducted clinical trials, and the Application Dossier are appropriate, you shall obtain IDL within about 9-12 months after submission. If clinical trials must be conducted, the general procedure is:

Step 1. Submitting an application and if the Application Dossier are appropriate, you shall obtain Clinical Trials Permission (CTP) within about 10-12 months after submission

Step 2. Conducting the clinical trials, if just carry out bioequivalence trials, it might be take 3 to 6 months, but other clinical trials might be take more than 1-1.5 year to complete.

Step 3. Submitting the Application Dossier (include the reports of clinical trials) and if the Application Dossier are appropriate, you shall obtain IDL within about 12-18 months after submission Please contact us for details about this and for more information including, we shall send the further information and our quotation to you after receive the introduction of your products.

提示 Notice

不同类型的GACC注册，海外申请人可以根据自身情况，选择不同的渠道进行注册申请。
1. 如果你精通GACC注册流程，可以直接向中国海关提交免费申请，其网站为：www.customs.gov.cn or www.singlewindow.cn；
2. 如果你是第一次申请，不清楚GACC注册的程序h流程，申请文件要求等，可以通过CRA中国代理机构渠道申请注册，CRA会提供专业的注册咨询服务，帮助你顺利通过GACC注册审查，尽快获得GACC注册号。

Different types of GACC registration, overseas applicants can choose different channels to apply for :
1. If you specialise in the GACC registration process, you can submit a free application directly to China Customs, website: www.customs.gov.cn or www.singlewindow.cn;
2. If you are not clear about the registration process of GACC registration, application document requirements, etc., you can apply for registration through the channel of CRA (Chinese Representative Agency) , CRA will provide professional registration services to help you successfully pass the GACC registration review and get the GACC registration number quickly.

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◄ The procedure for Import Drug NMPA Registration ►

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