The nomenclature principle of recombinant therapeutic biological products in Chinese Pharmacopoeia (2020 Edition) is to be revised

Wen Di Di Si Nan On December 9, 2019, focusing on the overall goal of the 13th five year plan for national drug safety, and taking the establishment of "the most rigorous standard" as the criterion, in order to further improve the naming principle of generic names of biological products, standardize the generic names of therapeutic biological products, ensure the full life cycle traceability and pharmacovigilance supervision of listed drugs, and avoid the use of the same pass for "more than one drug" or different drugs After the deliberation of the relevant professional committee of the 11th Pharmacopoeia Committee, it is proposed to further revise and improve the relevant provisions of the first supplement of the 2015 edition of the Chinese Pharmacopoeia "general name naming principles of biological products" to avoid ambiguity in the implementation process; meanwhile, it is also proposed to further regulate the general name of recombinant therapeutic biological products to be included in the 2020 edition of the Chinese Pharmacopoeia Fan, now the relevant amendments are publicized for comments The publicity period is one month, which has far-reaching significance for the industry of recombinant therapeutic biological products This paper analyzes the proposed revised naming rules of recombinant therapeutic biological products The general name of recombinant therapeutic biological products is not a simple thing Most of the recombinant therapeutic biological products are macromolecular substances with complex structure, some or multi-component active substances, and the general name has relative diversity and complexity In order to further improve the naming principle of generic names of biological products, standardize the restructuring of generic names of therapeutic biological products, ensure the full life cycle traceability and pharmacovigilance supervision of listed drugs, and avoid the confusion of "more than one drug" or different drugs using the same generic name, the first supplement of Chinese Pharmacopoeia (2015 version) is proposed after deliberation by the relevant professional committees of the 11th Pharmacopoeia Committee The relevant provisions of the "naming principles for common names of biological products" are further revised and improved to avoid ambiguity in the implementation process The contents to be revised are as follows: In 2015 edition of Chinese Pharmacopoeia, there are 11 varieties of recombinant therapeutic biological products with 36 specific varieties (including dosage forms) included in the revised naming principles of varieties The list of varieties is as follows: The new recombinant therapeutic biological products proposed to be revised and named in Chinese Pharmacopoeia 2020 involve 6 varieties, 13 specific varieties (including dosage forms), and the list of varieties is shown in the table below: