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Charging Rates for Drug Registration





国家药品监督管理局和省级药品监督管理部门依照法定职责,对药物临床试验申请、药品上市许可申请、补充申请和再注册申请开展行政受理、现场检查/核查、技术审评等注册工作,并按标准收取有关费用。具体收费标准如下:

National Medical Products Administration and the provincial Medical Products Administration shall, in accordance with their statutory duties, perform the administrative acceptance, on-site inspection/verification, technical review and other registration procedures for Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), supplementary applications and re-registration applications, and charge related fees according to the rates specified as follows:

 

 

 

单位:万元

Unit: in ¥10,000

项目分类

Classification

境内生产

Domestic

境外生产

Imported

新药注册费

Registration fee for INDs, NDAs

临床试验Clinical trials

19.20

37.60

上市许可Production/marketing

43.20

59.39

仿制药注册费

Registration fee for ANDAs

无需临床试验的上市许可

Production/marketing not requiring clinical trials

18.36

36.76

需临床试验的上市许可

Production/marketing requiring clinical trials

31.80

50.20

补充申请注册费

Registration fee for supplementary applications

无需技术审评的

General items

0.96

0.96

需技术审评的

Items requiring technical review

9.96

28.36

药品再注册费(五年一次)

Drug re-registration fee (once every five years)

由省级价格、

财政部门制定

Set by the provincial price & financial departments

22.72

注:Notes:

1.药品注册收费按一个原料药或一个制剂为一个品种计收,如再增加一种规格,则按相应类别增收20%注册费。 
1. Drug registration fee shall be charged on the basis of one API or preparation; for each strength added, an additional 20% registration fee of the corresponding category shall be charged.

2.《药品注册管理办法》中属于省级药品监督管理部门备案/报告类变更或国务院药品监督管理部门备案/报告类变更的申请事项,不收取注册费。
2. With regard to supplementary applications, no registration fees shall be charged if the items applied are subject to filing management by the provincial Medical Products Administration or National Medical Products Administration as per the Provisions for Drug Registration; if such applications elicits technical review upon verification, the applicant shall pay the registration fee in accordance with the rates for supplementary applications requiring technical review.

3.申请一次性进口药品(药材)的,按照一个药品(药材)收取药品注册费0.20万元。
3. For application of one-time import of drugs, a registration fee of ¥2,000 shall be charged.

4.境外生产的药品注册收费标准在境内相应注册收费标准基础上加收境内外检查交通费、住宿费和伙食费等差额。
4. The charging rates for registration of imported drug shall balance fees for domestic and international transportation, lodging and board on the basis of the corresponding rates for domestic registration.

5.港、澳、台药品注册收费标准按境外生产的药品注册收费标准执行。

5. The charging rates for registration of drugs imported from Hong Kong, Macao and Taiwan shall follow the those for imported drug registration.

6.药品注册加急费收费标准另行制定。

6. The charging rates for expedited drug registration shall be separately formulated.