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Document: Concept paper on the development of a guideline for using owner assessment as efficacy parameter-2026/1/23
2026-01-26查看详情 > -
Document: Human medicines highlights 2022-2026/3/3
2026-03-04查看详情 > -
Document: Annex 1 - Standard Operating Procedure for the Implementation of Virtual Control Groups in Preclinical Studies-2026/3/31
2026-04-01查看详情 > -
Document: Timetable accelerated assessment request for initial marketing authorisation applications-2026/5/13
2026-05-14查看详情 > -
关于公开征求《化学仿制药参比制剂目录（第一百零八批）》（征求意见稿）意见的通知-2026/6/26
2026-06-29查看详情 > -
Document: Breakthrough status request: Template for applicants for breakthrough medical devices pilot-2026/8/3
2026-08-04查看详情 > -
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (Draft)-2022/11/10
2022-11-30查看详情 > -
国家药监局综合司公开征求《关于加强委托生产药品上市许可持有人监管工作的通知 （征求意见稿）》意见-2023/5/24
2023-05-24查看详情 > -
Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)-2023/11/21
2023-11-23查看详情 > -
Document: CHMP PROM minutes for the meeting on 02 December 2024-2025/1/20
2025-01-21查看详情 >
