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Document: Clinical Data Publication (CDP) - Questions and Answers (Q&As) on the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070) work-share initiative with Health Canada (HC)-2026/4/21
2026-04-22查看详情 > -
国家药监局药审中心关于发布《非无菌化学药品及原辅料微生物限度研究技术指导原则（试行）》的通告（2023年第11号）-2023/02/21
2023-02-21查看详情 > -
Scientific guideline: DRAFT qualification opinion for GFR slope as a Surrogate Endpoint in RCT for CKD-2023/9/6
2023-09-07查看详情 > -
Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act-2025/1/6
2025-01-07查看详情 > -
Page: Procurement-2025/2/7
2025-02-10查看详情 > -
Page: Contacts at the European Medicines Agency-2025/3/14
2025-03-17查看详情 > -
Page: ICH M15 guideline on general principles for model-informed drug development - Step 2b - Scientific guideline-2025/4/16
2025-04-16查看详情 > -
Document: Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations-2025/6/2
2025-06-03查看详情 > -
关于公开征求药品电子通用技术文档（eCTD）相关技术文件和申报资料目录层级对应表意见的通知-2025/7/4
2025-07-07查看详情 > -
Document: Ketoprofen: European public maximum-residue-limit assessment report (EPMAR) - CVMP-2025/8/6
2025-08-07查看详情 >
