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Pharmaceutical Excipient IPEL china NMPA register Cost & time

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



 Generic Pharmaceutical Excipient  IPEL china CFDA registration Cost:

ITEM

COST

TIME

NOTE

China CFDA Registration consulting & Legal responsibility Agency

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1 Months

 

Technical documents Translation

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0.5-1 Months

 

CFDA Application Dossier Draft, Pre-review, Submit

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3-5 Months

 

NICPBP Excipient Tests & Follow up

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3-6 Months

 

Bioequivalence /Pharmacokinetics Study & CRO Service Cost

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3-6 Months

 

CDE Technical Evaluation & Follow up

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6-9 Months

 

CFDA IPEL Approval & Follow up

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3-6 Months

 

Other (Document Notarization etc.)

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0.5-1 Months

 

Total:

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18-24

Months

Not include the BE cost


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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