INTERPRETATION

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

by Grace Wang
Feb 11, 2022

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, 20201

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:

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.

Waivers for Micro and Small Enterprises

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

Drug Applications eligible for waivers

Drug registration fees can be waived for micro and small enterprises that submit innovative drug applications for

(1) Traditional Chinese medicines and their active ingredients 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 active pharmaceutical ingredients (API) 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. 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.

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.

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. Drug User Fees in the U.S.

*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 2021

FY 2022

Change

Prescription Drug User Fee Amendments (PDUFA)3

Application

Clinical data required

$2,875,842

$3,117,218

á$241,376

No clinical data required

$1,437,921

$1,558,609

á$120,688

Program

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

$336,432

$369,413

á$32,981

Generic Drug User Fee Amendments (GDUFA)4

ANDA

$196,868

$225,712

á$28,844

DMF

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

$69,921

$74,952

á$5,031

Program

Large size (≥20 approved ANDAs)

$1,542,993

$1,536,856

â$6,137

Medium size (6-19 approved ANDAs)

$617,197

$614,742

â$2,455

Small size (≤5 approved ANDAs)

$154,299

$153,686

â$613

Facility

Domestic API

$41,671

$42,557

á$886

Foreign API

$56,671

$57,557

á$886

Domestic FDF

$184,022

$195,012

á$10,990

Foreign FDF

$199,022

$210,012

á$10,990

Domestic CMO

$61,341

$65,004

á$3,663

Foreign CMO

$76,341

$80,004

á$3,663

Biosimilar User Fee Amendments (BsUFA)5

Biosimilar biological product development (BPD)

Initial BPD

$102,494

$57,184

â$45,310

Annual BPD

$102,494

$57,184

â$45,310

Reactivation

$204,988

$114,368

â$90,620

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

--

Waivers

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.

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

Generic drug application

No waivers.

Know 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.

Know more about Biosimilar User Fee Amendments (BsUFA).

 As a pharma regulatory service provider, BaiPharm has rich experience in submitting

  • clinical trial applications (CTA);

  • drug master files (DMF) for active pharmaceutical ingredients (API), pharmaceutical excipients and packaging materials;

  • new drug applications (NDA);

  • abbreviated new drug applications (ANDA) for generics.

Contact BaiPharm if you need professional help.


Grace Wang
ChemLinked Regulatory Analyst
+ FOLLOW
Copyright: unless otherwise stated all contents of this website are ©2022 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com