Final feedback from European Medicine Agency (EMA) to the EU Commission request to evaluate the impact of the removal of titanium dioxide from the list of authorised food additives on medicinal products
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医药市场销售数据分析 · 医院、实体药店、网上药店
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2026-10-14
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颁布机构：国家市场监督管理总局 2026-09-30
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最新指导原则
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国家药监局器审中心关于发布<人表皮生长因子受体2基因扩增检测试剂(荧光原位杂交法)注册审查指导原则(2026年修订版)>等2项注册审查指导原则的通告(2026年第28号)
2026-10-13
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questions and answers on biosimilar development and the bpci act: guidance for industry(生物类似药开发与<生物制品价格竞争与创新法案>问答:行业指南)
2026-10-09
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postapproval manufacturing changes to biosimilar and interchangeable biosimilar products: questions and answers(生物类似药和可互换生物类似药产品的批准后生产变更:问答)
2026-10-09
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国家药监局器审中心关于发布有源植入式医疗器械电池注册审查指导原则的通告(2026年第27号)
2026-10-08
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国家药监局器审中心关于发布腹腔内窥镜手术系统注册审查指导原则 第5部分:患者模型试验研究>的通告(2026年第26号)
2026-09-28
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国家药监局综合司公开征求<医疗器械生产质量管理规范无菌医疗器械检查指导原则(征求意见稿)>等意见
2026-09-24
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关于公开征求ich<e14/s7b:问答:致qt/qtc 间期延长及潜在致心律失常作用的临床和非临床评价问答>指导原则问答文件实施建议和中文翻译稿意见的通知
2026-09-24
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国家药监局药审中心关于发布<药物临床试验计算机化系统和电子数据指导原则>的通告
2026-09-22
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国家药监局药审中心关于发布<化学仿制药滴眼剂研究技术指导原则>和<化学仿制药特殊滴眼剂研究技术指导原则>的通告
2026-09-02
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determining whether to submit an anda or a 505(b)(2) application(确定是提交仿制药申请(anda)还是505(b)(2)申请)
2026-08-17
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cvm gfi #260 - type vii veterinary master file for research and development and risk reviews(cvm行业指南第260号——用于研发与风险审查的vii型兽药主文件)
2026-08-14
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container closure systems for human drugs and biological products(人用药品和生物制品的容器密闭系统)
2026-08-13
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formal meetings between the fda and sponsors or applicants of pdufa products(关于fda与处方药使用者付费法案(pdufa)产品申办方或申请人之间正式会议的指南)
2026-08-12
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国家卫生健康委办公厅关于印发医疗机构卒中中心建设与管理指导原则(2026年版)的通知
2026-07-28
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hemodialysis blood tubing sets - premarket notification (510(k)) submissions: guidance for industry and food and drug administration staff(血液透析血液管路套装 - 上市前通知(510(k))申报资料:行业和食品药品监督管理局工作人员指南)
2026-07-23
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2026-10-15
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2026-10-15
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摩熵咨询 33 34
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摩熵咨询 20 8
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颁布机构：国家药品监督管理局药品审评中心 2026-09-28
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颁布机构：国家药品监督管理局 2026-09-10
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颁布机构：四川省经济和信息化厅、中共四川省委军民融合发展委员会办公室、四川省教育厅、四川省科学技术厅、四川省人力资源和社会保障厅、四川省卫生健康委员会、四川省医疗保障局、四川省中医药管理局、四川省药品监督管理局 2026-08-04
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 reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients(关于制定支持儿科患者抗癌药物开发的概念验证数据反思文件的概念文件)
2026-03-13
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overview of comments received on the draft reflection paper on the qualification of non-mutagenic impurities(关于非致突变性杂质界定问题的征求意见稿所获意见综述)
2026-03-13
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eu implementation strategy of ich e2d(r1) guideline - post-approval safety data: definitions and standards for management and reporting of individual case safety reports(ich e2d(r1) 指导原则在欧盟的实施策略——上市后安全性数据:个例安全性报告的管理与报告定义及标准)
2026-03-06
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guideline on the clinical investigation of medicinal products for the treatment of cystic fibrosis(治疗囊性纤维化药品临床研究指导原则)
2026-03-02
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draft concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products(关于制定微生态药物非临床研发与评价思考文件的概念性文件草案)
2026-03-02
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overview of comments on ich m4q(r2) : guideline on the common technical document for the registration of pharmaceuticals for human use - quality - step 2b(关于ich m4q(r2)<人用药品注册通用技术文档——质量部分>指导原则(第2b阶段)的意见概述)
2026-02-20
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overview of comments received on ich e20 guideline on adaptive designs for clinical trials (ema/chmp/ich/206586/2025)(关于ich e20<临床试验适应性设计指导原则>(ema/chmp/ich/206586/2025)的意见概述)
2026-02-16
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concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of myasthenia gravis(关于制定重症肌无力治疗药物临床研究指导原则的必要性概念文件)
2026-02-13
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concept paper on revision of the guidelines on good manufacturing practice for medicinal products - annex 6 manufacture of medicinal gases(关于修订<药品生产质量管理规范指南——附件6:医用气体生产>的概念文件)
2026-02-11
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ich m15 guideline on general principles for model-informed drug development - step 5(ich m15<模型引导的药物研发通用原则指导原则>- 第5阶段)
2026-02-11
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overview of comments received on q&a regarding co-processed excipients used in solid oral dosage forms h and v (ema/chmp/cvmp/qwp/422493/2024)(关于固体口服制剂h & v中使用的共处理辅料的问答意见概述(ema/chmp/cvmp/qwp/422493/2024))
2026-01-28
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questions and answers regarding co-processed excipients used in solid oral dosage forms (h & v)(关于在固体口服制剂中使用的共处理辅料的问答(h & v))
2026-01-28
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overview of comments received on on ich q3e guideline and supporting documentation for extractables and leachables (ema/chmp/ich/236669/2025 and ema/chmp/ich/236668/2025)(关于ich q3e指南和支持文件中提取物和浸出物的意见概述(ema/chmp/ich/236669/2025和ema/chmp/ich/236668/2025))
2026-01-28
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overview of comments received on q&a regarding co-processed excipients used in solid oral dosage forms h and v (ema/chmp/cvmp/qwp/422493/2024)(关于口服固体制剂用共处理辅料(h和v)问答文件(ema/chmp/cvmp/qwp/422493/2024)的意见概述)
2026-01-28
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overview of comments received on guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities(关于治疗下肢周围动脉闭塞性疾病药物临床研究指南的意见综述)
2026-01-27