Publication of the general name of biological products

In accordance with the relevant requirements of the State Administration for the work of generic names of biological products, after many times of investigation and discussion by our commission, the "guidelines for the naming of generic names of biological products" has been drafted and approved by the relevant professional committees of the 11th Pharmacopoeia Commission Now, the "guide to the naming of generic names of biological products" is publicized online for comments for 2 weeks (November 21-december 5, 2018) Contact person and contact information: Zhao Yuhao, biological products department Tel: 010-67079625 email: zhaoyuhao@chp.org.cn Annex: general name naming guide for biological products (online publication draft) National Pharmacopoeia Committee November 21, 2018 general name naming guide for biological products (online publication draft) I Preface The generic name of a drug, i.e non patent name, is the name identifying a medicinal substance or active ingredient, which is unique, global and public The generic name of drugs is an important guarantee for the whole life cycle traceability and pharmacovigilance supervision of listed drugs Biological products are mostly macromolecular substances with complex structure and high heterogeneity, and some or multi-component active substances Their common names have relative diversity and complexity The generic name of biological products is to determine the pharmaceutical category of products by evaluating the structure / function, mechanism of action and other elements of the active ingredients, and give them a specific and unique name according to the general classification principle, so as to ensure that the quality, clinical safety and effectiveness of biological products with the same generic name are clear after relevant evaluation, and at the same time, according to this name It is said that information related to clinical adverse reactions can be accurately found in the tracing of pharmacovigilance The nomenclature of innovative biological products shall be based on the development of technology and the requirements of relevant domestic and foreign technical regulations, and the principle of specific analysis shall be adopted In order to cooperate with the research and development of biological products in China, guide the scientific and reasonable naming of biological products, promote the development of biological medicine industry, ensure the safety and effectiveness of clinical medication and the traceability of pharmacovigilance, this guide is specially formulated 2、 Scope of application: the biological products referred to in this guide are the varieties and categories included in the explanation of terms in the third part of Chinese Pharmacopoeia This guide is applicable to preventive biological products, therapeutic biological products and in vitro diagnostic reagents under the management of drugs according to the registration classification of biological products in the current version of the measures for the administration of drug registration 3、 The applicant for the common name can submit the application for the common name and relevant information to the National Pharmacopoeia Committee in the NDA stage according to the relevant requirements The national pharmacopoeia committee shall accept the application for the generic name of biological products in accordance with relevant procedures and designate the confirmed generic name The application has been included in the World Health Organization (who) international non patent name (inn: International Non proprietary name) recommended generic name list of biological products, which can directly obtain the Chinese generic name; the application for the generic name of biological products other than whoinnproprietary list, whose proposed generic name needs to be confirmed after no objection through online publicity After the national pharmacopoeia committee completes the relevant technical examination, it shall reply to the general name determined by the applicant by letter, and send a copy to the drug evaluation center of the State Food and drug administration The generic name of biological products shall be approved by the State Drug Administration and come into effect after the issuance of the product registration approval 4、 The basic principles of naming generic names different kinds of biological products have different characteristics, and their generic names have different characteristics "Naming principle of general name of biological products" in Chinese pharmacopoeia is the legal basis for naming the general name of biological products The naming principle is based on the classification of recombinant therapeutic biological products, vaccines and biological products extracted from human and animal tissues On this basis, referring to the international general rules, the specific naming principles of corresponding varieties are formulated respectively Different types of biological products should conform to the corresponding general name naming principles 1 Whoin n, a therapeutic biological product, has been classified as inn, which is a commonly used name in the world According to the relevant requirements of "general name naming principles of biological products" in Chinese Pharmacopoeia, whoinn should be used as the general name of therapeutic biological products in principle, instead of the traditional general name of structure / function description For therapeutic biological products that have been approved for marketing and use the traditional common name, such as whoinn, it should be proved to conform to the relevant description of their structure and mechanism of action under the specific varieties of inn The State encourages innovative therapeutic biological products to apply for Inn in accordance with the relevant requirements of whoinn in the early stage of research and development; apply directly to the National Pharmacopoeia Committee for the generic name of innovative therapeutic biological products, and also specify the generic name in accordance with the relevant requirements of "principles for naming generic names of biological products" in the Chinese Pharmacopoeia, referring to whoinn naming principles Therapeutic biological products shall conform to the general principle of the general name of drugs On this basis, the general name shall be determined according to the classification principles of non glycosylated protein / polypeptide, glycosylated protein / polypeptide, monoclonal antibody, fusion protein, pegylated protein, gene therapy product and cell therapy product For specific principles, please refer to the general name of biological products in Chinese Pharmacopoeia Naming principles Under the existing pharmacovigilance traceability system in China, for recombinant therapeutic biotechnology products, referring to the principles of most countries in the world, at this stage, the same generic name is used for the original research biological products listed in China and the non original research biological products with the same active component structure and the same mechanism of action Under the premise of complying with the relevant national laws and regulations, the application can be approved Please use different trade names for further differentiation; in order to guide clinical medication, for non original research biological products (including biological similar drugs), it is necessary to indicate the research situation of similarity comparison with the original research drug and the description of drug replacement risk in the instruction manual 2 Biological products without Inn classification, such as vaccines, blood products from human and animals, allergenic raw products, microecological products and in vitro diagnostic reagents according to drug management, continue to follow the traditional general name naming principle, usually named by diseases, microorganisms, specific components or materials, etc for specific classification and related naming principles, please refer to the Chinese Pharmacopoeia“ The principle of nomenclature for biological products shall be implemented References: 1 Drug Administration Law of the people's Republic of China, 2 Measures for the administration of drug registration issued by the State Food and drug administration, 3 Supplement to pharmacopoeia of the people's Republic of China 2015 Edition (in print), 4 Who ﹐ Inn ﹐ BQ proposal ﹐ http://www.who.int/medicines/services/inn/who ﹐ Inn ﹐ BQ ﹐ proposal ﹐ 2015 PDF? UA = 1 5.USFDA：NonproprietaryNamingofBiologicalProductsGuidanceforIndustry https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm459987.pdf 6.TGA：Consultation:NomenclatureofBiologicalMedicines https://www.tga.gov.au/sites/default/files/consultation-nomenclature-biological-medicines.pdf 7 Technical guidelines for research, development and evaluation of biological similar drugs http://www.cde.org.cn/zdyz.do? Method = largepage & id = 243