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 biologic products
Class 1: Innovative vaccines that have not been granted marketing authorization in or outside China
Class 1.1: Vaccines for diseases that have no effective prevention measures.
Class 1.2: New antigens developed on the basis of the approved vaccines, e.g., new 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 been granted 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.
① vaccines with changes in expression system or cell media;
② vaccines with changes in bacteria/viruses or bacteria/viruses in the approved vaccines;
③ vaccines with changes in cell media or the genes of interest in the approved vaccines;
④ purified vaccines improved on the basis of unpurified vaccines;
⑤ component vaccine improved on the basis of whole cell vaccines, etc.
Class 2.3: New multi-linked/multivalent vaccines made by combining the vaccine products, of which there have already been the same type of approved vaccine products.
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 targeted groups of people.
Class 3: Vaccines that have been granted marketing authorization in or outside China
Class 3.1: Vaccines that are manufactured outside China, with marketing authorization outside but not in China, and are applying for marketing authorization in China.
Class 3.2: Vaccines that have received marketing authorization outside China but not in China, 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 that have not been granted marketing authorization in or outside China
Class 2: Improved biological products based on biologics that have been granted 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 and other aspects based on approved products.
Class 2.2: Biologics adding a new indication that has not been approved in or outside China, or changing the target group of people who can use the drug.
Class 2.3: New compound products made by combining biological products, of which there have already been the same type of approved biological products.
Class 2.4: Biological products with major technical improvements based on approved products by e.g.,
① replacing the bio-tissue extraction technology with the recombinant technology;
② changing the amino acid sites, amino acid expression systems or host cells to make the new products have distinct clinical advantages over the approved ones.
Class 3: Biological products that have been granted 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 received marketing authorization outside China but not in China, and are applying for manufacturing and marketing authorizations in China.
Class 3.3: Biosimilars.
Class 3.4: Other biological products.
In vitro diagnostic reagents that are administered as biologics
Class 1: Innovative IVD reagents
Class 2: IVD reagents that have been granted marketing authorization in and outside China
* Including IVD reagents for blood screening and IVD reagents labeled by radionuclide.
Applicants shall determine the biological product's classification for marketing authorization application. During the review, the biological product's classification won't be changed.
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 firstname.lastname@example.org.