On October 23, 2017, CFDA issued the revised measures for the administration of drug registration (revised version). Meanwhile, the attached requirements for the registration classification and application data of biological products (trial) reclassified the biological products for therapeutic use, changing the original 15 categories into 5 categories and making the classification more clear. Meanwhile, the definition of innovative drugs has changed from "new in China" to "new in the world".

Category 1: new biological products: refers to new therapeutic biological products that have not been listed at home or abroad. By treatment with biological products listed components consisting of a new compound preparation, on the basis of overseas listed products, senior changed amino acid sequences, protein structure and form of polymer, change the modification after translation, or chemical modification was carried out on the product (including PEG coupling modification, etc), shall, in accordance with the registration category 1, report to the class.

New gene therapy and cell therapy biological products (such as innovative mechanism, new vector, new target cells, etc.) shall be declared according to category 1 of registration.

Type 2 categories: improved biological products: refers to the domestic and overseas listed products, based on the structure of its preparation level (such as affecting the release and bioavailability of the particle size and its distribution, preparation technology such as inclusion, polymer crystallization structure of change) dosage forms and prescription craft, dosing way optimization, indications for increasing, optimization or drug groups (such as children, the elderly medication groups); Or products prepared by DNA recombination technology for the first time (such as replacing synthesis technology with recombinant technology, biological tissue extraction technology, etc.), or products prepared by different methods from domestic and overseas products (such as using different expression systems, host cells, etc.).

Biological products such as gene therapy and cell therapy, which are improved on the basis of domestic and foreign products already on the market, shall be declared in accordance with the registration classification 2.

In addition to the extrapolation of medicines for children, the improved new biological products should have obvious clinical advantages or significant improvements in the safety and quality control of the products.

Category 3: biological products listed overseas and unlisted in China: if the original research drugs/reference drugs are only listed overseas, the applicant can apply for clinical trial of biological products developed according to biological similar drugs; If the application for research and development cannot be made according to the technical requirements of biological analogs, the applicant shall apply for the application for clinical trials in category 1 or 2 according to the registered classification of the products.

In principle, biological products under class 3 registration shall not be allowed to conduct clinical trials until their original original research/reference drug has been approved for domestic clinical trials. After completion of the clinical trial, the listing application shall be submitted according to the appropriate registration classification according to the current situation. Category 4: domestic listed biological products. Include:

4.1 biosimilar drugs;

4.2 biological products that cannot be developed and declared according to the technical requirements of bio-similar drugs.

Category 5: imported biological products: classified into the same 4 situations above according to their maturity procedures.

5.1 new biological products;

5.2 improved biological products;

5.3 biological products listed abroad and unlisted in China: including clinical trial application and listing application submitted by overseas listed original research drugs, as well as clinical trial application of imported biological products developed according to biological similar drugs. If the applicant is unable to apply for research and development according to the technical requirements of biosimilar drugs, the applicant shall apply for clinical trial application according to category 5.1 or category 5.2 of the registered classification according to the product situation;

5.4 domestic listed biological products. If the original research drug has been listed in China, the applicant shall apply for the biological products developed according to the biological similar drugs.