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Page: Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline-2025/4/11
2025-04-13查看详情 > -
Page: COVID-19 medicines-2025/5/26
2025-05-27查看详情 > -
Document: Real-world evidence framework to support EU regulatory decision-making: 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025-2025/6/30
2025-07-01查看详情 > -
Document: Qualification opinion for Simcyp Simulator-2025/8/1
2025-08-04查看详情 > -
Document: Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms-2025/9/19
2025-09-22查看详情 > -
国家药监局药审中心关于发布《化学药品批准后药学变更管理方案技术指导原则(试行)》的通告(2025年第46号)-2025/10/28
2025-10-29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)-2025/11/26
2025-11-27查看详情 > -
Document: HMA-EMA joint Network Data Steering Group meeting - 6 November 2025-2025/12/22
2025-12-23查看详情 > -
Document: List of medicines currently in PRIME scheme-2026/2/5
2026-02-06查看详情 > -
Page: Union list of critical medicines-2026/3/13
2026-03-16查看详情 >