China Biological Product Registration Classification

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.

For example,

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.

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.