对产品规格文件中“聚糖概要”部分内容的建议

The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products Pub Date : 2021-12-02 DOI:10.30895/1991-2919-2021-11-4-273-275

O. A. Vaganova

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引用次数: 0

摘要

“Glycan Profile”是单克隆抗体活性成分或终产物和促红细胞生成素活性成分的生产企业产品规格文件的必要组成部分。俄罗斯联邦卫生部联邦国家预算机构“药品专家评价科学中心”的专家为逐步介绍测试程序提供建议，这将使申请人能够调整俄罗斯和外国生产的药品的产品规格文件，帮助专家尽量减少或消除要求申请人提供额外信息的需要。并将有助于药品的及时批放行。

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Recommendations for the Contents of the “Glycan Profile” Part of a Product Specification File

“Glycan Profile” is a necessary part of manufacturers’ product specification files for monoclonal antibody active ingredients or final products and erythropoietin active ingredients. The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.

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The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products

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