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Document: IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants-2025/12/2
2025-12-03查看详情 > -
国家药监局关于28批次不符合规定药品的通告（2025年第47号）-2026/1/6
2026-01-07查看详情 > -
Page: Plasma master file certificates-2026/2/9
2026-02-10查看详情 > -
Page: PRIME: priority medicines-2026/3/18
2026-03-19查看详情 > -
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 > -
Certain Postapproval Requirements and Resources for ANDAs-2026/6/4
2026-06-05查看详情 > -
Document: Questions and answers on Article 30 referral procedures-2026/7/15
2026-07-16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 >
