Attention! The State Drug Administration has formulated the Requirements for the Classification and Declaration of Biological Products

Guide: In line with the implementation of the Measures for the Administration of Drug Registration, the State Drug Administration has formulated the Requirements for the Classification and Reporting of Biological Products Registration.in cooperation with the Implementation of the Measures for the Administration of Drug Registration, the State Drug Administration has formulated the Requirements for the Classification and Declaration of Biological Products Registration, which are hereby issued and described below.. On the classification of biological products, it will be implemented from July 1, 2020.2. The requirements for the declaration of biological products shall be implemented from October 1, 2020. By September 30, 2020, the filing of the information may be submitted as required.hereby hereby announce.Annex: Registration and classification of biological products and declaration data requirementsthe State Drug Administrationbiological products registration classification and declaration information requirementsbiological products refers to microorganisms, cells, animals or human-derived tissue seinfluids as the starting raw materials, made from biological technology, used in the prevention, treatment and diagnosis of human diseases preparations. In order to regulate the registration and declaration and management of biological products, biological products are divided into preventive biological products, therapeutic biological products and in vitro diagnostic reagents managed by biological products.prevention biological products are vaccine biologics, including immunization vaccines and non-immune-planned vaccines, for the prevention and control of disease and prevalence.Therapeutic biologics are biological products used in the treatment of human diseases, such as proteins, peptides and their derivatives prepared by engineered cells (such as bacteria, yeast, insects, plants and mammalian cells) using different expression systems; Inviviable diagnostic reagents for biological products are managed according to biological products for therapeutic use.in vitro diagnostic reagents managed by biological products include in vitro diagnostic reagents for blood source screening, in vitro diagnostic reagents labeled with radionuclides, etc.the classification of drug registration sits at the time of the application for listing, and the review process shall not be changed by the listing of other drugs both inside and outside China.Part I Prevention Biological Products , Registered Classification1: Innovative Vaccines: Vaccines not on the market at home or abroad:1.1 Vaccines without effective means to prevent diseases.1.2 New antigen forms developed on the basis of listed vaccines, such as new gene recombinant vaccines, new nucleic acid vaccines, new combination vaccines prepared on the basis of marketed polysaccharides, etc.1.3 vaccines with new adjuvants or new adjuvants systems.1.4 multi-link/multivalent vaccine selling new antigens or new antigens.Category 2: Improved Vaccines: Improved domestic or overseas vaccine products to improve the safety, effectiveness, quality control of new products, and have obvious advantages of vaccines, including:2.1 on the basis of domestic or overseas listed products to change the antigen spectrum or type, and has a clear clinical advantage of the vaccine.2.2 vaccines with significant technical improvements, including vaccine strains/cell matrix/production processes/dosage forms, etc. (e.g. replacing a vaccine with another expression system or cell matrix, replacing or modifying a listed strain of strains, modifying listed cell matrix or target genes, improving a non-purified vaccine to a purified vaccine, improving whole-cell vaccine to a component vaccine, etc.)2.3 A new multi-link/multivalent vaccine consisting of a vaccine that has been listed for similar products.2.4 change the route of administration, and has a clear clinical advantage of the vaccine.2.5 altered immune dose or immune procedure, and new immune dose or immune procedure has a clear clinical advantage of the vaccine.2.6 changes the vaccine for the affected population.categories 3: domestic or overseas listed vaccines:3.1 overseas production of overseas listed, domestic unlisted vaccines declared for listing.3.2 Overseas listed and domestic unlisted vaccines declared for domestic production and listing.3.3 vaccines are on the market., the requirements of the declaration informationthe relevant reference to the relevant acceptance examination guidelines for the certification documents.application for clinical trial of vaccines and registration for listing, the applicant shall prepare the declaration materials in accordance with the M4: General Technical Document (CTD) for the Registration of Human Drugs (CTD). Regional information 3.2.R is required in the annex. the specific contents of the declaration materials should comply with the requirements of the CTD format, but also in accordance with the requirements of the relevant regulations and technical guidelines that are constantly updated. According to the law of drug research and development, in the different stages of declaration, pharmaceutical research, including process and quality control is a gradual progressive and perfect process. Different biological products also have their own pharmaceutical characteristics. If the applicant does not consider it necessary to submit one or some of the studies required for the declaration, it shall be indicated that it is not applicable and provide a full basis. . IchM4's requirements for biological products are mainly for genetically engineered recombinant products, according to the characteristics of vaccine research, but also need to consider: pharmaceutical aspects: 1. The consideration of different types of vaccine pharmaceutical data on the basis of the basic framework of ICHM4, according to the characteristics of the vaccine should be submitted in accordance with the characteristics of the production of bacteria (toxic), process development, process description, quality characteristics of research and other information. . 2. The consideration of seed batch and cell matrix for vaccine declaration sistationinvolving virus-related species, the production of toxic species information shall be submitted in part 3.2.S.2.3. to provide in 3.2.S.2.3 the review and verification report of the third-party verification body approved by the central inspection court and the relevant pharmaceutical regulatory agency for the batching and production of seed batches for the production of bacteria (toxic) seeds. . 3. Adjacetors adjulates related research materials submitted to the following two parts: submit an overview of adjormto in 3.2.P, submit complete pharmaceutical research information in 3.2.A.3, including raw materials, processes, quality properties, testing methods, stability, etc. . 4. External factor security evaluation should be in accordance with the relevant technical guidelines for external factor security system analysis. Overall, traditional vaccines can refer to the requirements of vaccine-related requirements, recombinant vaccines can refer to the requirements of biological products for recombinant therapy. target virus inactivation verification data is submitted in the 3.2.S.2.5 process verification section. non-target virus removal/inactivation verification study was submitted in the 3.2.A.2 external factor safety evaluation section. . 5. Multi-link/multi-price vaccine for multi-price vaccines, according to the differences in production processes and quality control of each type of component to consider the organization of the reporting information, if more similar, can be described in the same 3.2.S chapter, if the difference is large, can be submitted to a separate 3.2.S chapter. when the product contains multiple components (e.g. combined vaccines, or with thinners), a complete section of the original fluid and/or preparation may be provided for each component. non-clinical research: 1. Adjute for adjunics, such as pharmaceutical substitutes, toxicology research, in accordance with the basic framework of ICHM4 submitted in the corresponding part; . 2. Multi-linked/multivalent vaccine multi-link/multivalent vaccine antigen ratio reasonable, multivalent vaccine antibody cross-protection activity research content in 4.2.1.1 major pharmaceutical efficacy part submitted. . 3. Other other safety studies, except for conventional safety studies, may be submitted in the other toxicity studies section s4.2.3.7. Clinical Trials: " trial drug test report and trial drug trial records for experimental drugs (including placebos) "should be classified as "E3:9.4.2 research product identification", the specific information in the "16.1.6 if the use of more than one batch of drugs, the list of patients receiving a specific batch of experimental drugs/research products". applicants should submit the clinical trial database on CD-ROM on the basis of CTD when applying for registration of drugs in a clinical trial. Specific requirements such as database format and related documents can be found in the relevant guidelines for the submission of clinical trial data. overseas applicants applying for clinical trials of vaccines for minors in China, they shall obtain at least Phase I clinical trial data from overseas target populations. Except for vaccines that are urgently needed in response to major public health emergencies or those identified by the state-level health authorities as urgently needed. Part II Therapeutic Biological Products , Registered Classification 1 category: Innovative Biological Products: Domestic and Foreign are not listed for therapeutic biological products. 2 categories: improved biological products: domestic or overseas listed products to improve the safety, effectiveness, quality control of new products have improved, and has obvious advantages of therapeutic biological products. 2.1 On the basis of listed products, the dosage form, the route of administration, etc. are optimized, and the biological products with obvious clinical advantages. 2.2 Increase the number of new indications and/or changes in drug use, both inside and outside the country, which are not approved. 2.3 Biological products listed by similar products form new compound products. 2.4 On the basis of listed products, biological products with significant technological improvements, such as recombinant technology to replace biotissue extraction technology, compared with the listed products to change amino acid site or expression system, host cell has obvious clinical advantages. categories 3: domestic or overseas listed biological products: 3.1 overseas production of overseas listed, domestic unlisted biological products declared for listing. 3.2 Overseas listed, domestic unlisted biological products declared for domestic production and listing. 3.3 Biosimilars. 3.4 other biological products. 2. Declaration Information Requirements 1. For applications for clinical trials of biological products for therapeutic use and applications for listing registration, applicants shall prepare declaration materials in accordance with the M4: General Technical Document (CTD) for the Registration of Human Drugs (hereinafter referred to as CTD). Regional information 3.2.R is required in the annex. . 2. The specific contents of the declaration materials should comply with the requirements of the CTD format, but also in accordance with the requirements of the relevant regulations and technical guidelines that are constantly updated. According to the law of drug research and development, in the different stages of declaration, pharmaceutical research, including process and quality control is a gradual progressive and perfect process. Different biological products also have their own pharmaceutical characteristics. If the applicant does not consider it necessary to submit one or some of the studies required for the declaration, it shall be indicated that it is not applicable and provide a full basis. . 3. For biosimilars, the contents of the Quality Similarity Evaluation section may be submitted in "3.2.R.6 Other Documents". . 4. For antibody drug conjugate or modified products, the research materials of small molecule serological pharmacology may be submitted separately in accordance with the requirements of ctD format and content, or all pharmaceutical research materials may be submitted in "3.2.S.2.3 Material Control". . 5. For compound products or multi-component products, each component may be submitted to a complete original liquid and /or preparation chapter. . 6. For cell and gene therapy products, pharmaceutical research materials may be submitted in the corresponding part of the original liquid and/or preparation according to the characteristics of the product, and "Not applicable" may be indicated for items not applicable. For example, the pharmaceutical research data of plasmids and viral vectors in key raw materials may be submitted in the "3.2.S.2.3 Material Control" section with reference to the requirements of the CTD format and content. . 7. When the applicant submits a registration application for the listing of a drug in a clinical trial, he or she shall submit the clinical trial database on cd-ROM on the basis of CTD. Specific requirements such as database format and related documents can be found in the relevant guidelines for the submission of clinical trial data. . 8. According to the provisions of the exemption from clinical trials of the injection of the muscle of ordinary or specific human immunoglobulin, human haemoglobin, etc. , can be directly submitted for listing. . 9. Invival diagnostic reagents in biological products are prepared in accordance with CTD. Part III By Biological Products Management of in vitro Diagnostic Reagents, Registered Classification 1 category: Innovative in vitro Diagnostic Reagents. Category 2: In vitro diagnostic reagents listed both inside and outside China. 2. The declaration information requirements in vitro diagnostic reagents can directly apply for listing. (i) Summary 1. Product Name 2. Documentary documents 3. Patent situation and the status of ownership 4. The basis of the title 5. Self-assessment report 6. Product description and drafting statement
.