Drug Application Fees for FY 2022 in China and the U.S.

In general, drug regulators 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.), the top two largest 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 2022 is Oct. 1, 2021-Sept. 30, 2022). 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 DMF Filing & Drug Application Fee

China Drug Registration Fee Standards and Detailed Rules for Implementing the Drug Registration Fee Standards effective from July 1, 2020
Type		Produced in China	Produced Outside China
DMF	Generic 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
New drug registration	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
Supplemental application	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.

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