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.
China Drug Registration Fee Standards and Detailed Rules for Implementing the Drug Registration Fee Standards effective from July 1, 2020 1
Type
Produced in China
Produced Outside China
DMF
Generic active pharmaceutical ingredient (API) used in drug product already approved in China
Pharmaceutical excipient/packaging material
New drug registration
Marketing authorization application (new drug application, NDA)
Generic drug registration
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
Notes:
Each application fee is for one strength only. 20% more fee will be charged for another strength.
New drug fees apply to all classes of biological products.
An administrative fee notice will be sent from NMPA to the applicant after the authority accepts the drug application.
Payment should be made within 15 workdays after the acceptance.
Drug registration fees can be waived for micro and small enterprises that submit certain types of drug applications.
Manufacturer
Non-manufacturer
Micro
Annual revenue: ＜ ¥3,000,000
Small
Annual revenue: ¥3,000,000-¥20,000,000
(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.
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.
Applicant
Submission
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.
*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.
Type
FY 2022
FY 2023
Change
Application
