The following information should be provided in the cover letter of applications for transitioning a Clinical Trial authorised under the Directive 2001/20/EC to the Clinical Trial Regulation
2023-06-27
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指导原则
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欧盟药品注册（HMA）
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最新指导原则
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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)
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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
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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)
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国家药监局器审中心关于发布<中心静脉导管注册审查指导原则(2026年修订版)>的通告(2026年第23号)
2026-07-15
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2026-07-02
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国家药监局关于发布<脑机接口医疗器械产品分类界定指导原则><脑机接口医疗器械通用名称命名指导原则>等2项医疗器械产品指导原则的通告(2026年第24号)
2026-06-30
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关于公开征求<以患者为中心创新药研发统计方法学技术指导原则(征求意见稿)>意见的通知
2026-06-25
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关于公开征求<斑秃治疗药物临床试验技术指导原则>(征求意见稿)意见的通知
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全球药物研发中心
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Proteins EU-SRS User Guide Guidance on naming and building protein records in EU-SRS
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116th Heads of Medicines Agencies Meeting
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CTCG Best Practice Guide for sponsors of multinational clinical trials with different Part I document versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014
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115th Heads of Medicines Agencies Meeting
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EU-Innovation Network Workplan 2024
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The following information should be provided in the cover letter of applications for transitioning a Clinical Trial authorised under the Directive 2001/20/EC to the Clinical Trial Regulation
2023-06-27
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Joint HMA-EMA Big Data Steering Group
2023-06-12
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Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014
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Meeting of the Homeopathic Medicinal Products Working Group (HMPWG) In person meeting 27-28 October 2022 Rome, Italy
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HMA Core Group for medical devices Statement on effective application of the EU regulatory system for medical devices
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Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use
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CTCG recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials
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同地域最新指导原则
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Veterinary Vaccines EU-SRS User Guide Guidance on the naming and building of veterinary vaccine substance records in EU-SRS
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Polymers EU-SRS User Guide Guidance on naming and building polymer records in EU-SRS
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Mixtures EU-SRS User Guide Guidance on naming and building mixture records in EU-SRS
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116th Heads of Medicines Agencies Meeting
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CTCG Best Practice Guide for sponsors of multinational clinical trials with different Part I document versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014
2024-03-07
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115th Heads of Medicines Agencies Meeting
2024-01-24
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EU-Innovation Network Workplan 2024
2024-01-17
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The following information should be provided in the cover letter of applications for transitioning a Clinical Trial authorised under the Directive 2001/20/EC to the Clinical Trial Regulation
2023-06-27
-
Joint HMA-EMA Big Data Steering Group
2023-06-12
-
Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014
2023-06-12
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Meeting of the Homeopathic Medicinal Products Working Group (HMPWG) In person meeting 27-28 October 2022 Rome, Italy
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HMA Core Group for medical devices Statement on effective application of the EU regulatory system for medical devices
2022-12-07
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Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use
2022-05-13
-
CTCG recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials
2022-04-04