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.
①vaccines with changes in expression system or cell media,
②vaccines with changes in bacteria/viruses or bacteria/viruses in the approved vaccines that are already on the market,
③vaccines with changes in cell media or the genes of interest in the approved vaccines that are already on the market,
④purified vaccines that are developed on the basis of unpurified vaccines,
⑤component 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. ①the recombinant technology replaces the bio-tissue extraction technology,
②the 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.
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.
The administration fees of biological product's marketing applications are the same with new drugs.
2. Administration Fee3
Domestic products (RMB)
Imported products (RMB)
ANDA without clinical trial
ANDA with clinical trial
Technical review not required
Technical review required
License renewal (every 5 years)
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 email@example.com.