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国家药监局药审中心关于发布《重组腺相关病毒载体类体内基因治疗产品申报上市药学共性问题与技术要求》的通告(2025年第39号)-2025/9/18
2025-09-19查看详情 > -
Document: Annex III - Written responses to list of issues - molecule-independent device bridging approach (MIDBA)-2025/10/24
2025-10-27查看详情 > -
Page: Type-II variations: questions and answers-2025/11/26
2025-11-27查看详情 > -
Document: Name Review Group form - questions and answers-2025/12/18
2025-12-19查看详情 > -
Document: Plasma Master File (PMF) requirements - questions and answers for PMF holders-2026/2/4
2026-02-05查看详情 > -
Document: CAT quarterly highlights and approved ATMPs - March 2026-2026/3/12
2026-03-13查看详情 > -
Page: Union Product Database-2026/4/9
2026-04-10查看详情 > -
Regulatory and procedural guideline: Member states contact points for review of national translations of Quick Response (QR) codes of veterinary medicinal products authorised via the centralised, mutual recognition, decentralised (...)-2023/01/05
2023-01-05查看详情 > -
关于《乙酰半胱氨酸颗粒生物等效性研究指导原则(征求意见稿)》等五项技术指导原则公开征求意见的通知-2023/7/27
2023-07-28查看详情 > -
国家药监局关于修订深海龙丸和深海龙胶囊非处方药说明书范本的公告(2024年第10号)-2024/2/5
2024-03-11查看详情 >