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 | |||
Type | Produced in China | Produced Outside China | |
DMF | Generic active pharmaceutical ingredient (API) used in drug product already approved in China | ¥183,600 | ¥367,600 |
Other API | ¥216,000 | ¥296,950 | |
Pharmaceutical excipient/packaging material | free | free | |
New drug registration | Clinical trial | ¥192,000 | ¥376,000 |
Marketing authorization application (new drug application, NDA) | ¥432,000 | ¥593,900 | |
Generic drug registration | Clinical trial | ¥134,400 | ¥134,400 |
Marketing authorization application (abbreviated new drug application, ANDA) with clinical trials | ¥318,000 | ¥502,000 | |
ANDA without clinical trials | ¥183,600 | ¥367,600 | |
Supplemental application | Technical review not required | ¥9,600 | ¥9,600 |
Technical review required | ¥99,600 | ¥283,600 | |
License renewal (every five years) | Determined by provincial authorities | ¥227,200 | |
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. | |||
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
Manufacturer | Non-manufacturer | |
Micro | Employee: ＜20; Annual revenue: ＜ ¥3,000,000 | Employee: ＜10 |
Small | 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
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. |
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.
Type | FY 2022 | FY 2023 | Change | |
Application | Clinical data required | $3,117,218 | $3,242,026 | $124,808 |
No clinical data required | $1,558,609 | $1,621,013 | $62,404 | |
Program *Paid no more than five times by one applicant in one FY. | $369,413 | $393,933 | $24,520 | |
ANDA | $225,712 | $240,582 | $14,870 | |
DMF *The fee is for the completeness assessment of Type II API DMFs. | $74,952 | $78,293 | $3,341 | |
Program | Large size (≥20 approved ANDAs) | $1,536,856 | $1,620,556 | $83,700 |
Medium size (6-19 approved ANDAs) | $614,742 | $648,222 | $33,480 | |
Small size (≤5 approved ANDAs) | $153,686 | $162,056 | $8,730 | |
Facility | Domestic API | $42,557 | $37,544 | $5,013 |
Foreign API | $57,557 | $52,544 | $5,013 | |
Domestic FDF | $195,012 | $213,134 | $18,122 | |
Foreign FDF | $210,012 | $228,134 | $18,122 | |
Domestic CMO | $65,004 | $51,152 | $13,852 | |
Foreign CMO | $80,004 | $66,152 | $13,852 | |
Backlog | $17,434 | $17,434 | - | |
Biosimilar biological product development (BPD) | Initial BPD | $57,184 | $47,325 | $9,859 |
Annual BPD | $57,184 | $47,325 | $9,859 | |
Reactivation | $114,368 | $94,650 | $19,718 | |
Application | Clinical data required | $1,746,745 | $1,746,745 | - |
Clinical data not required | $873,373 | $873,373 | - | |
Program *No more than five times of program fees for one applicant in one FY. | $304,162 | $304,162 | - | |
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). |
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