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    Home > Active Ingredient News > Drugs Articles > General name naming guidelines for biological products publicize that drug traceability will be improved in the future

    General name naming guidelines for biological products publicize that drug traceability will be improved in the future

    • Last Update: 2018-11-23
    • Source: Internet
    • Author: User
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    [industry trends of China Pharmaceutical network] recently, the State Pharmacopoeia Commission published the "guidelines for the naming of generic names of biological products" (hereinafter referred to as the "guidelines") on the Internet for comments, with the publicity time of 2 weeks (November 21-december 5, 2018) It is understood that the purpose of this guide is 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 biomedical industry, and ensure the safety and effectiveness of clinical medication and the traceability of pharmacovigilance In recent years, with the rapid development of China's biomedical industry, at the same time, the relevant drug safety issues have been highly valued For example, the vaccine product development, production, sales and other chain links need to be strictly managed to ensure the safety of its quality and efficacy With the continuous increase of domestic supervision, biomedical enterprises are also persistently developing and producing safe and safe biological products, producing and selling products in strict accordance with GMP requirements, so as to ensure the consistency and traceability of the whole process from raw and auxiliary material procurement, drug production to drug release and sales The publication of this guideline is also to further strengthen the traceability and safety of drugs According to the guidelines, the generic name of a drug is a name that identifies a medicinal substance or active ingredient, which has the characteristics of sex, global universality and public interest The generic name of drugs is an important guarantee for the whole life cycle traceability and pharmacovigilance supervision of listed drugs However, the generic name of biological products is not a simple job It is understood that 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 needs to determine the pharmaceutical category of products by evaluating the structure / function and mechanism of action of the active ingredients, and give them specific names according to the general classification principle, so as to ensure that the product quality, clinical safety and effectiveness of biological products with the same generic name can be determined after relevant evaluation, and at the same time, according to this The name can accurately find the information related to clinical adverse reactions in the tracing of pharmacovigilance The guide shows that, in terms of scope of application, the biological products referred to here are the varieties and categories included in the explanation of the terms in three parts of the Chinese Pharmacopoeia, which are applicable to the preventive biological products, therapeutic biological products and in vitro diagnostic reagents managed by drugs according to the registration and classification of biological products in the current version of the measures for the administration of drug registration In addition, different kinds of biological products have different characteristics, and their common names have different characteristics According to the "general name naming principles of biological products" in Chinese Pharmacopoeia, it is necessary to classify the recombinant therapeutic biological products, vaccines and biological products extracted from human and animal tissues Different types of biological products should conform to the corresponding general name naming principles Among them, for the therapeutic biological products with the existing Inn classification, for example, the general name of the therapeutic biological products should be who Inn, 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, it should be proved to conform to the relevant description of their structure and mechanism of action under the specific varieties of inn However, for 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, the traditional general naming principle is still followed, usually named by diseases, microorganisms, specific components or materials According to the guidelines, the applicant can submit the application and relevant information of generic name naming to the National Pharmacopoeia Committee at the NDA stage according to relevant requirements.
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