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最新改良型新药及创新药立项开发
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Overview of comments received on ICH guideline Q5A (R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
2023-03-27
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指导原则
欧洲
现行有效
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欧洲药品管理局（EMEA）
最新政策法规资讯
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政策法规解析 创新药临床审批 政策变动 采集意见
药通社2025-06-17
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医药器械 政策解析 采集 市场分析
摩熵医械2025-06-03
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政策解析 宠物医疗 驱虫药
药融圈2025-05-29
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医保局 政策法规 三类医用耗材 采购新规
摩熵器械2025-05-28
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FDA 临床试验 CGT 药物审评审批 法案
生物药大时代2025-05-19
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国家药品集采 政策 药企 药品信息变更
药通社2025-02-20
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医用耗材 医用耗材集采 集采新规
tyc7111cc太阳成集团2025-01-08
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医保 医疗保障工作 医保改革
tyc7111cc太阳成集团2024-12-17
最新指导原则
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关于征集<中心静脉导管产品注册技术审查指导原则(2025年修订版)>修订工作参与企业及单位信息的通知
2025-05-30
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市场监管总局关于发布<特定全营养配方食品临床试验技术指导原则 肝病>等文件的公告
2025-05-26
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国家药监局药审中心关于发布<阿尔茨海默病药物临床试验技术指导原则(试行)>的通告(2025年第19号)
2025-05-22
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zonisamide(唑尼沙胺-be指导原则)
2025-05-20
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migalastat hydrochloride(盐酸米加司他-be指导原则)
2025-05-20
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ceftobiprole medocaril sodium(头孢比罗酯钠-be指导原则)
2025-05-20
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daridorexant(奈莫雷生-be指导原则)
2025-05-20
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epinephrine(肾上腺素-be指导原则)
2025-05-20
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metformin hydrochloride(盐酸二甲双胍-be指导原则)
2025-05-20
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zilucoplan sodium
2025-05-20
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deutetrabenazine(氘丁苯那嗪-be指导原则)
2025-05-20
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terbinafine(特比萘芬-be指导原则)
2025-05-20
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etrasimod arginine(依曲莫德-be指导原则)
2025-05-20
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国家药监局器审中心关于发布移动医疗器械注册审查指导原则(2025年修订版)的通告(2025年第9号)
2025-05-07
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关于发布2025年度医疗器械注册审查指导原则编制计划的通告(2025年第10号)
2025-05-07
同部门最新指导原则
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Direct healthcare professional communication (DHPC) : Updated recommendations to minimise the risks of malignancy, major adverse cardiovascular events, serious infections, venous thromboembolism and mortality with use of Janus kinase inhibitors (JAKi)
2023-03-30
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Overview of comments received on ICH guideline Q5A (R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
2023-03-27
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Acceptability of IU as abbreviation for International Units in the strength of human medicinal products
2023-03-24
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Direct healthcare professional communication (DHPC) : Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan
2023-03-14
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Guideline on computerised systems and electronic data in clinical trials
2023-03-10
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Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy
2023-03-01
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Draft European Union herbal monograph on Cnicus benedictus L., herba
2023-02-16
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EU/3/02/107: Public summary of positive opinion for orphan designation of purified bromelain for the treatment of partial deep dermal and full thickness burns
2023-02-15
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Concept paper on revision of the ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’
2023-02-14
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ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b
2023-02-07
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 (R1) on quality risk management - Step 5 - Revision 1
2023-02-06
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Guideline on clinical evaluation of vaccines - Revision 1
2023-02-01
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Overview of comments on 'Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance'
2022-12-16
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Qualification opinion for the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients
2022-12-16
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Overview of comments received on Draft Qualification Opinion of the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients
2022-12-16
同地域最新指导原则
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concept paper on the development of a guideline on assessment and reporting of mechanistic models used in the context of model informed drug development(关于在模型指导下药物开发中使用机制模型评估和报告的指南制定的概念性文件)
2025-02-14
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draft reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3rs - revision 1(人类药品监管测试与3rs实施机会草案反思 - 修订1)
2025-02-13
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implementation strategy of ich guideline m12 on drug interaction studies(ich指南m12药物相互作用研究实施策略)
2025-02-13
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budesonide, prolonged release tablets, 9 mg product- specific bioequivalence guidance(布地奈德缓释片(9毫克)产品特定生物等效性指南)
2025-02-12
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budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg product-specific bioequivalence guidance(布地奈德胃溶硬胶囊(3毫克)、胃溶颗粒(9毫克)产品特定生物等效性指南)
2025-02-12
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trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance(曲美替尼(0.5毫克和2毫克)薄膜包衣片产品特定生物等效性指南)
2024-12-19
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ich q4b(r1) guideline on evaluation and recommendation of pharmacopoeial texts for use in the ich regions - step 5(ich q4b(r1)指南:对在ich区域使用的药典文本的评估和推荐 - 第5步)
2024-12-18
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guideline on core smpc for human normal immunoglobulin for subcutaneous and intramuscular administration (scig/imig)(人用皮下及肌内注射正常免疫球蛋白(scig/imig)核心摘要产品特性指南)
2024-12-05
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draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (scig/imig) - revision 2(人正常免疫球蛋白皮下和/或肌内给药(scig/imig)临床研究指南草案-第二版)
2024-12-05
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guideline on the clinical requirements for non-replacement therapy in haemophilia a and b(a型和b型血友病非替代疗法的临床要求指南)
2024-12-04
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concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control( 关于修订体重控制药物临床评价指南中儿童体重控制附录的必要性概念文件)
2024-12-03
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draft ich e6(r3) guideline for good clinical practice – annex 2 - step 2b(ich e6(r3)良好临床实践指南草案—附件2—第2b步)
2024-11-29
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draft ich m15 guideline on general principles for model-informed drug development - step 2b(ich m15指南草案:基于模型的药物开发一般原则——第2b步)
2024-11-29
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submission of comments template for ich e6(r3) annex 2(提交ich e6(r3)附件2的意见模板)
2024-11-29
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question & answer on the need for bioequivalence studies with acid reducing agents (aras)(酸还原剂(aras)生物等效性研究的必要性问答)
2024-11-13
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