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)...
在欧盟,主要有一项指南(《与医疗器械一起使用的药品质量文件指南》Guideline on quality documentation for medicinal products when used with a medical device),可被视为与 FDA 的 eCTD 技术合规指南 相当。此外,要牢记《医疗器械法规...
2021年7月发布《与医疗器械一同使用时药品质量文件申报指南》(Guideline on Quality Documentation for Medicinal Products When Used with a Medical Device),该文件明确了药品与医疗器械一起使用的3种不同但常见的配置,即集成单一单元、共包装、引用标签。 美国FDA在21 CFR 3.2(e)中对组合产品定义为由2种及以上...
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.doc,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 “N
This guideline is not applicable to herbal, biological, biotechnological products, radiopharmaceuticals and radiolabelled products. This guideline is applicable to active substances that have been developed following a “traditional” or an “enhanced” approach or a combination of these. However, when ...
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
Process validation is mentioned as life cycle, comparable to Annex 15 and to the EMA guideline on process validation for finished products . Also comparable to both, the guideline offers a traditional or an enhanced (with reference to ICH Q 11) approach to process validation. A combination of...
afullrevisionofthisguideline.Thischangeisconsideredtobeminoranduncontroversialandconsequentlya consultationphasewasconsideredtobeunnecessary. *此次修订是更新术语中的“在线”测量定义,无意对此指南进行全面修订。该修订作为无争议轻微修 订,因此不必经过征求意见阶段。