[Updated] Drug Application Fees for FY 2023 in China and the U.S.

by Grace Wang
Feb 10, 2023

Drug regulators generally charge fees from applicants to ensure the review of drug applications proceed efficiently. For drug applicants, the fees are legally bounded for acquiring or extending marketing authorization.

This article introduces drug application fees in China and the United States (U.S.), two large markets targeted by pharmaceutical companies.

China National Medical Products Administration (NMPA) has been implementing its latest version of drug registration fee standards since July 1, 2020. The standards are expected to remain in effect till its next version comes out. The fees are mainly charged for drug applications.

The U.S. Food and Drug Administration (FDA) updates its drug user fees every fiscal year (FY) which starts from Oct. 1 of last year and ends on Sept. 30 (e.g., FY 2023 is Oct. 1, 2022-Sept. 30, 2023). The drug user fees, which are collected from pharmaceutical industry stakeholders, are levied on applications, programs, and facilities.

*Drugs discussed in this article only refer to drugs for human use.

1. China

1.1 DMF Filing & Drug Application Fee Standards in China

China Drug Registration Fee Standards and Detailed Rules for Implementing the Drug Registration Fee Standards effective from July 1, 20201


Produced in China

Produced Outside China


Generic active pharmaceutical ingredient (API) used in drug product already approved in China



Other API



Pharmaceutical excipient/packaging material



New drug registration

Clinical trial



Marketing authorization application (new drug application, NDA)



Generic drug registration

Clinical trial



Marketing authorization application (abbreviated new drug application, ANDA) with clinical trials



ANDA without clinical trials



Supplemental application

Technical review not required



Technical review required



License renewal (every five years)

Determined by provincial authorities



Ÿ   Each application fee is for one strength only. 20% more fee will be charged for another strength.

Ÿ   New drug fees apply to all classes of biological products.

Ÿ   An administrative fee notice will be sent from NMPA to the applicant after the authority accepts the drug application.

Ÿ   Payment should be made within 15 workdays after the acceptance.

1.2 Waivers for Micro and Small Enterprises in China

Drug registration fees can be waived for micro and small enterprises that submit certain types of drug applications.

1.2.1 Micro and Small Enterprises (MSE) in the Pharmaceutical Industry2




Employee: <20;

Annual revenue: < ¥3,000,000

Employee: <10


Employee: 20-299;

Annual revenue: ¥3,000,000-¥20,000,000

Employee: 10-99

1.2.2 Drug Applications Eligible for Waivers

   (1) Traditional Chinese medicines and their APIs extracted from plants, animals, minerals and have not got marketing authorization in China for treating acquired immune deficiency syndrome (AIDs) or malignant tumors.

   (2) Chemical drug products and their APIs that are made via synthesis or partial synthesis and have not got marketing authorization in any countries/regions.

   (3) Class 1 therapeutic/prophylactic biological products. Read about biological product classifications in China.

In addition to the exemption of marketing applications for innovative drugs, an applicant has no need to pay for submitting supplemental applications during the clinical trials if it is eligible for the waiver of the clinical trial application fee.

1.2.3 Documentation for Requesting a Waiver

To request a waiver, an applicant should submit the following documents to NMPA:

   (1) Micro and Small Enterprise Waiver Request Form;

   (2) A copy of the business license;

   (3) Last year’s corporation tax report bearing the tax administration’s seal or the effective statistical form from the statistics bureau. 

1.2.4 Time to submit the waiver request



Already identified as MSE

Submit the drug application and the waiver request together

Not identified as MSE

Submit the MSE application, the drug application, and the waiver request together. 

2. The U.S.

2.1 Drug User Fee Standards in the U.S. (Effective period: Oct. 2022-Sept. 2027, that is, fiscal years 2023-2027)

   *The application fee is required for drug applications for marketing authorization/license.

   *The program fee is assessed annually for approved drug products.

   *The facility fee is charged on owners of active pharmaceutical ingredient (API) / finished dosage form (FDF) / contract manufacturing organization (CMO) facility.


FY 2022

FY 2023


Prescription Drug User Fee Amendments (PDUFA)3


Clinical data required




No clinical data required





*Paid no more than five times by one applicant in one FY.




Generic Drug User Fee Amendments (GDUFA)4






*The fee is for the completeness assessment of Type II API DMFs.





Large size (≥20 approved ANDAs)




Medium size (6-19 approved ANDAs)




Small size (≤5 approved ANDAs)





Domestic API




Foreign API




Domestic FDF




Foreign FDF




Domestic CMO




Foreign CMO








Biosimilar User Fee Amendments (BsUFA)5

Biosimilar biological product development (BPD)

Initial BPD




Annual BPD









Clinical data required




Clinical data not required





*No more than five times of program fees for one applicant in one FY.




 2.2 Waivers of Drug Application Fees in the U.S.

Prescription drug application

Can be waived if

-       necessary for protecting the public health

-       assessment of the fees would significantly hinder the innovation due to certain circumstances including limited resources;

-       the applicant involved is a small business (with fewer than 500 employees, including employees of affiliates) submitting its first human drug application for review.

Learn more about Prescription Drug User Fee Amendments (PDUFA).

Generic drug application

No waivers.

Learn more about Generic Drug User Fee Amendments (GDUFA).

Biosimilar application

Can be waived if the applicant

-       is a small business (with fewer than 500 employees, including employees of affiliates) submitting its first biosimilar biological product application to the FDA for review, and

-       does not have a drug product that has been approved under a human drug application, and introduced or delivered for introduction into interstate commerce.

Learn more about Biosimilar User Fee Amendments (BsUFA).

Contact BaiPharm if you need professional help with drug applications

Grace Wang
ChemLinked Regulatory Analyst & Editor
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