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国家药监局药审中心关于发布 《以患者为中心的药物临床试验设计技术指导原则(试行)》《以患者为中心的药物临床试验实施技术指导原则(试行)》《以患者为中心的药物获益-风险评估技术指导原则(试行)》的通告(2023年第44号)-2023/7/27
2023-07-28查看详情 > -
国家药监局 海关总署关于增设合肥空港口岸为药品进口口岸的公告(2024年第12号)-2024/2/6
2024-03-11查看详情 > -
Document: Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues-2025/1/31
2025-02-05查看详情 > -
Document: European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for national competent authorities (NCAs) (JSON) (YAML)-2025/3/10
2025-03-11查看详情 > -
Document: Innovation Task Force (ITF) briefing meeting request form-2025/4/10
2025-04-11查看详情 > -
Page: ICH E6 Good clinical practice - Scientific guideline-2025/5/23
2025-05-26查看详情 > -
Document: PRAC recommendations on signals adopted at the 2-5 June 2025 PRAC meeting-2025/6/30
2025-07-01查看详情 > -
Document: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025-2025/7/30
2025-07-31查看详情 > -
Page: Network Data Steering Group (NDSG)-2025/9/18
2025-09-19查看详情 > -
Page: Opinions and letters of support on the qualification of novel methodologies for medicine development-2025/10/24
2025-10-27查看详情 >