EMA Revises Guideline on Clinical Development Requirements for Fixed Combination Products
On July 22, 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted for publication theguideline on quality documentation for medicinal products when used with a medical device(similar to “combination products” referred to by the US FDA)...
关键词: 欧洲药品管理局;草药产品;草药制剂;草药物质;稳定性指示实验 中图分类号:R951 文献标志码:A 文章编号: 1674-6376(2019)09-1696-09 DOI:10.7501/j.issn.1674-6376.2019.09.002 Consideration of guideline on quality of herbal medicinal products/traditional herbal medicinal products by EMA SUN Yu, ...
(Generic medicinal product application)、改良申请(Hybrid application)、生物类似药申请(Similar biological medicinal products application)、良好应用药品申请(Well-established medicinal use application)、固有复方制剂申请(Fixed combination medicinal products application)和知情授权申请(Informed consent application)6种...
8月15日,欧洲药品管理局(EMA)发布《Guideline on quality of herbal medicinal products/traditional herbal medicinal products》(草药产品/传统草药产品质量指南)草案,用于征求公众意见。 自2006年发布第一版征求意见稿,2006年10月1日正式启用,直至2011年发布第二版定稿。
6) ICH harmonized guideline S9 Q&A (2018): Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals. 不同指导原则之间相互补充,重点看ICH指导原则,但也要关注相关国家的不同要求。比如FDA指导原则包括了生物大分子药联用的描述,ICH-S6(R1)虽然是针对生物大分子的指南,但并未提及联用策略,...
EMA制剂成品生产指南-2017(中英文)完整版.pdf,EMA 制剂成品生产指南-2017 4 JJuly 2017 EMA/CHMP/QWP/245074/2015 Committee for Human Medicinal Products (CHMP) Guideline on manufacture of the finished dosage form 制剂成品生产指南 This guideline replaces the
regulatoryComments Offon EMA’s new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers May122016 Share: For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to qualit...
EMA关于固定复方药物临床开发指导原则介绍 药事管理 ㊀作者简介:周誉ꎬ女ꎬ审评员ꎬ研究方向:药品审评工作ꎬＥ－ｍａｉｌ:ｚｈｏｕｙ＠ｃｄｅ.ｏｒｇ.ｃｎ ＥＭＡ关于固定复方药物临床开发指导原则介绍 周誉ꎬ任曼茹ꎬ宫新江 (国家食品药品监督管理总局药品审评中心ꎬ北京１０００２２)摘要:欧洲药品管理局(...
多肽的合成和生产指南(EMA)draft-guideline-development-and-manufacture-synthetic-peptides_en.pdf,1 12 October 2023 2 EMA/CHMP/CVMP/QWP/387541/2023 3 Committee for Medicinal Products for Human Use (CHMP) 4 Committee for Veterinary Medicinal Products (CVMP