Cost & Time for Drug China NMPA Registration Approval(Clinical Trials Phase)

◄ Cost & Time for Drug China NMPA Registration Approval(Clinical Trials Phase) ►

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

Phase B. Clinical Trials Phase：

ITEM	COST (USD)	TIME
Traditional 4 phase Clinical Trials & CRO Service Cost （for Class 1-2 new drugs） l Phase I: need 20-30 groups l Phase I I: need 100 groups l Phase I I I: need 300 groups l Phase I I I I: need 2000 groups	contact us	2-5 years
Random verification Clinical Trials & CRO Service Cost （for Class 3-5 drugs） l Need 100-120 groups	contact us	1-2 years
Bioequivalence /Pharmacokinetics Study & CRO Service Cost (for class 6 Generic Drug) l Need 20-30 groups	contact us	0.5-1 year

ll Many factors affect the cost and time of clinical trials, for example:

1. The complexity of the clinical trial program operations, complex or simple

2 The risk of clinical trial, high risk or low risk

3 The incidence of disease cases, common diseases or rare diseases.

4 disease cases occurred, is a national disease, or endemic disease.

5 the number of clinical trial centers, single or Multi-center trial

6 Clinical Trials hospital grade, senior hospital or general hospital, public hospitals or private hospitals

7 clinical trial center position, in the center of the city, or outlying cities

8 Standard Reagents price of the control groups.

Etc.

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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◄ Cost & Time for Drug China NMPA Registration Approval(Clinical Trials Phase) ►

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