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国家药监局药审中心关于发布《基于人用经验的中药复方制剂新药药学研究技术指导原则(试行)》的通告(2023年第53号)-2023/10/18
2023-11-06查看详情 > -
Document: Agenda of the CVMP meeting 14-15 January 2025-2025/1/13
2025-01-14查看详情 > -
Document: Agenda - ACT EU workshop on ICH E6 (R3)-2025/2/18
2025-02-19查看详情 > -
Document: Decision on rules concerning the handling of declared interests of national experts on secondment, trainees, interims and visiting experts of the European Medicines Agency-2025/3/26
2025-03-27查看详情 > -
Page: List of medicines under additional monitoring-2025/4/30
2025-05-06查看详情 > -
Document: Annexes - 2024 annual report of the European Medicines Agency-2025/6/10
2025-06-11查看详情 > -
Document: Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.17-2025/7/16
2025-07-17查看详情 > -
Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)-2025/8/28
2025-08-29查看详情 > -
Page: VICH GL62 on target animal safety of veterinary monoclonal antibody products (VMAPs) St4-2025/10/2
2025-10-08查看详情 > -
Document: Medicine shortage communication (MSC) : Beriglobin (human normal immunoglobulin), 2 mL and 5 mL solution for injection in pre-filled syringe: supply shortage and cessation of marketing (discontinuation)-2025/11/11
2025-11-12查看详情 >