INTERPRETATION

China Biological Product Registration Classification

by Grace Wang
Oct 19, 2021

It is a critical step for overseas drug applicants to choose a right registration classification for marketing authorization in China. Only after determining the product's registration class, and with knowledge of corresponding fees and application dossier requirements, applicants can get on the right track for registration. 

Applicants can also evaluate the product to see if it is qualified for expedited programs for drug marketing approval.1

This article is expected to help you understand how China NMPA classifies biological products. For chemical drug registration classification, please click here.

You can also sign up at ChemLinked BaiPharm Portal and watch our webinar Drug Registration Classification system in China.

 

1. Biological Product Registration Classification

The Biological Product Registration Classification and Application Dossier Requirements2 released by NMPA was implemented on Oct. 1, 2020. The regulation classifies biological products into three broad categories:

  • prophylactic biological products;

  • therapeutic biological products;

  • in vitro diagnostic (IVD) reagents.

Each category is divided into more detailed classes:

Biological Product Registration Classification in China

Prophylactic biological products

Class 1: Innovative vaccines without   marketing authorization in or outside China

Class 1.1: Vaccines for diseases that currently have no effective prevention measures.

Class 1.2: New antigens developed on the basis of the approved vaccines that are already on the market. E.g. recombinant DNA vaccines, new nucleic acid vaccines, new conjugate vaccines made based on approved polysaccharide vaccines, etc.

Class 1.3: Vaccines containing new adjuvants or new adjuvant system.

Class 1.4: Multilinked/multivalent vaccines containing new antigens or new antigen forms.

Class 2: Improved vaccines based on vaccine products which have received marketing authorization in or outside China. The new vaccines have improvements in safety, efficacy and quality control, and distinct advantages.

Class 2.1: Vaccines made by changing the antigen spectrotype or type of the products that have received marketing authorization in or outside China. The new vaccines shall have distinct clinical values.

Class 2.2: Vaccines with major technical improvements, including improvements of the vaccines' bacteria & viruses, cell media, manufacturing techniques, dosage forms, etc.

For example,

vaccines with changes in expression system or cell media,

vaccines with changes in bacteria/viruses or bacteria/viruses in the approved vaccines that are already on the market,

vaccines with changes in cell media or the genes of interest in the approved vaccines that are already on the market,

purified vaccines that are developed on the basis of unpurified vaccines,

component vaccine that are developed on the basis of whole cell vaccines, etc.

Class 2.3: New multi-linked/multivalent vaccines made by combining the vaccine products and there have been the same kind products as the combined vaccines.  

Class 2.4: Vaccines that have changed administration routes and have distinct clinical advantages.

Class 2.5: Vaccines with changes in dosages or immune processes, and the new dosages or immune processes have distinct advantages.

Class 2.6: Vaccines with changes in target group

Class 3: Vaccines that have received marketing authorization granted in or outside China

 

Class 3.1: Vaccines that are manufactured outside China, with marketing authorization outside China only, and are applying for marketing authorization in China.

Class 3.2: Vaccines that have received marketing authorization outside China only, and are applying for manufacturing and marketing authorizations in China.

Class 3.3: Vaccines that have received marketing authorization in China.

Therapeutic Biological   Products

Class 1: Innovative therapeutic biological products without marketing authorization in and outside China

Class 2: Improved biological products based on biologics that have received marketing authorization in or outside China. The new therapeutic biological products have improvements in safety, efficacy and quality control, and distinct advantages.

Class 2.1: Biologics that have distinct clinical advantages with improvements in dosage forms, administration routes or other aspects based on approved products.

Class 2.2: Biologics that are added with a new indication that has never been approved in or outside China; or with changed target group.

Class 2.3: New compound products made by combing biological products and there has been the same kind of approved products as the combined biologics.

Class 2.4: Biological products with major technical improvements based on approved products on the market.

E.g. the recombinant technology replaces the bio-tissue extraction technology,

the amino acid sites, amino acid expression systems or host cells are changed, making the new products have distinct clinical advantages over the approved ones.

Class 3: Biological products that have received marketing authorization in or outside China

 

Class 3.1: Biological products that are manufactured outside China, having marketing authorization outside China, and applying for marketing authorization in China.

Class 3.2: Biological products that have marketing authorization outside China only, and are applying for manufacturing and marketing authorizations in China.

Class 3.3: Biosimilars.

Class 3.4: Other biological products.

In vitro diagnostic Reagents

 

Class 1: Innovative IVD reagents

Class 2: IVD reagents that have received marketing authorization in and outside China

* including IVD reagents for blood screening and IVD reagents labeled by radionuclide.

Notes:

  1. Applicants shall determine the biological product classification when propose a marketing authorization application. During the review in China, the biological product's classification won't be changed even if other drugs get marketing authorization.

  2. The administration fees of biological product's marketing applications are the same with new drugs.

 

2. Administration Fee3

Application Type

Domestic products (RMB)

Imported products (RMB)

New drug

Clinical trial

192,000

376,000

NDA

432,000

593,900

Generic drug

ANDA without clinical trial

183,600

367,600

ANDA with clinical trial

318,000

502,000

Variation request

Technical review not required

9,600

9,600

Technical review required

99,600

283,600

License renewal (every 5 years)

Provincial authority

227,200

Note: An application fee is for one application for one strength, and another   20% fee shall be charged for each application for an extra strength.

 For any questions about drug registration in China, welcome to contact us by sending an email to contact@chemlinked.com.


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