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Document: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes-2026/2/6
2026-02-09查看详情 > -
Page: Clinical pharmacology and pharmacokinetics: questions and answers-2026/3/17
2026-03-18查看详情 > -
Page: Respiratory syncytial virus (RSV)-2026/4/20
2026-04-21查看详情 > -
Document: Questions and answers on the refusal of a change to the marketing authorisation for Hetlioz (tasimelteon) (II-40)-2026/6/2
2026-06-03查看详情 > -
国家药监局药审中心关于发布《急性髓系白血病新药临床研发技术指导原则》的通告(2023年第3号)-2023/02/13
2023-02-13查看详情 > -
Regulatory and procedural guideline: Member states contact points for translations review (updated)-2023/8/30
2023-09-01查看详情 > -
国家药监局关于发布《药品生产质量管理规范(2010年修订)》药用辅料附录、药包材附录的公告(2025年第1号)-2025/1/2
2025-01-03查看详情 > -
Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)-2025/2/5
2025-02-10查看详情 > -
Page: Network Portfolio-2025/3/13
2025-03-14查看详情 > -
Page: Fees payable to the European Medicines Agency: General questions and answers-2025/4/15
2025-04-16查看详情 >