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成人用药数据外推至儿科人群的定量方法学指导原则（试行）-2023/4/12
2023-04-13查看详情 > -
国家药监局关于化学原料药再注册管理等有关事项的公告（2023年第129号）-2023/10/13
2023-10-13查看详情 > -
Document: QRD veterinary product-information highlighted template version 9.1-2025/1/7
2025-01-08查看详情 > -
国家中医药局综合司 国家药监局综合司关于发布《古代经典名方关键信息表（“旋覆代赭汤”等43首方剂）》的通知（国中医药综科技发〔2025〕1号）-2025/2/14
2025-02-18查看详情 > -
Page: Guidance on the application of the amended Variations Regulation from 1 January 2025-2025/3/25
2025-03-26查看详情 > -
2025年4月28日中药品种保护受理公示-2025/4/28
2025-04-29查看详情 > -
Hernia Mesh – Package Labeling Recommendations-2025/6/6
2025-06-06查看详情 > -
Document: Q&A extract - SPOR and XEVMPD status update webinar 9 April 2025-2025/7/11
2025-07-14查看详情 > -
Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 July 2025 PRAC-2025/8/20
2025-08-21查看详情 > -
Document: Draft guideline on the clinical evaluation of medicinal products intended for the treatment of chronic hepatitis B (CHB) - Revision 1-2025/9/30
2025-10-08查看详情 >
