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Document: Guidance for rapporteurs and members of drafting groups of documents developed by the GMP/GDP Inspectors Working Group-2026/1/16
2026-01-19查看详情 > -
关于公开征求《化学仿制药参比制剂目录（第一百零四批）》（征求意见稿）意见的通知-2026/2/25
2026-02-27查看详情 > -
Document: Member states contact points for translations review-2026/3/25
2026-03-26查看详情 > -
Page: Tafamidis soft gelatin capsules 20 mg and 61 mg product-specific bioequivalence guidance-2026/4/30
2026-05-02查看详情 > -
Document: Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for Identification of Medicinal Products (IDMP) in Europe: Registration requirements to public PMS API (beta release) - Chapter 1
2026-06-15查看详情 > -
中心对外公开征求《药品审评书面发补标准》（征求意见稿）意见的通知-2026/7/24
2026-07-26查看详情 > -
Competitive Generic Therapies (Final)-2022/10/5
2022-11-15查看详情 > -
关于公开征求《药品监管信息化标准体系（征求意见稿）》-2023/4/11
2023-04-14查看详情 > -
《药品经营和使用质量监督管理办法》政策解读-2023/10/13
2023-10-13查看详情 > -
Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants-2025/1/8
2025-01-09查看详情 >
