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 |
| 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:
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