附录4:将审查具体病症指南(Condition Specific Guidance),考虑是否将其替换为独立的思考性文件,以便根据需要独立修订。 主指南:将根据ICH E9(R1)补充文件对特定章节进行更新(例如,第2节),并根据单臂试验思考性文件(EMA/CHMP/430688)对单臂试验部分进行修订,以改进指导原则、澄清建议并避免不一致。此外,还将增加针对血...
包括：Obtaining an EU marketing authorisation获得欧盟的上市许可, The evaluation of medicines step-by-step逐步获得欧盟市场许可、Pre-authorisation guidance授权前相关指南、Fees缴费、Product information产品信息、Pharmacovigilance药物警戒和Compliance法规。Eudralex 第1卷 ：人用医药产品的药品法规，在这里可以查询EC颁...
The general guidance should be used to develop product-specific protocols to demonstrate equivalence, facilitated by obtaining scientific advice, as necessary. 关于安全性和局部耐受性的等效性可以从活性物质的知识和已完善的辅料的选择中推断岀来。针对简单配方,从渗透动力学或药效等效性研究中可获得生物等效豁免...
包括:Obtaining an EU marketing authorisation获得欧盟的上市许可, The evaluation of medicines step-by-step逐步获得欧盟市场许可、Pre-authorisation guidance授权前相关指南、Fees缴费、Product information产品信息、Pharmacovigilance药物警戒和Compliance法规。 Eudralex 第1卷 :人用医药产品的药品法规,在这里可以查询EC颁...
包括:Obtaining an EU marketing authorisation获得欧盟的上市许可, The evaluation of medicines step-by-step逐步获得欧盟市场许可、Pre-authorisation guidance授权前相关指南、Fees缴费、Product information产品信息、Pharmacovigilance药物警戒和Compliance法规。 Eudralex 第1卷 :人用医药产品的药品法规,在这里可以查询EC...
Ask the Expert: Product Inspection, Part Two; Automated Product Inspection and Cold Chain Considerations Industry Outlook 2025: Regulating Technology for the Future Ask the Expert: Complying with 21 CFR 211.110 Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary PackagingRelated...
制剂成品生产指南 This guideline replaces the “Note for Guidance on Manufacture of the Finishe d Dosag e Form”(CPMP/QWP/486/95)原创：2017-09-19 翻译组 GMP办公室 翻译：王世华 校对：Owen Executive summary 综述 This guideline replaces the note for guidance on the manufacture of the finish...
Guidance is provided on the documentation expected for sterile finished products, sterile active substances, sterile excipients and sterile primary containers (referred to as container in this guideline) in a new marketing authorisation application or a variation application for a medicinal product, ...
Under specific conditions, aseptic processing may be accepted even if terminal sterilisation of the product itself would be possible, e.g. in the case of eye drops in polyethylene containers enabling administration of single drops or pre-filled pens. Here, terminal sterilisation of the product would...
Immunological veterinary medicinal product 免疫学兽药产品 一种用于动物的兽药产品, 使动物产生主动或被动免疫或诊断免疫。 Lethal (process) 致死 杀死微生物的过程。 Overkill sterilisation 过度灭杀 具有F0BIO > 12 分钟灭杀力的工艺。比如,能够提供至少12log微生物降低的最小 D 值为1分钟。