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Master Protocols for Drug and Biological Product Development-2026/6/24
2026-06-24查看详情 > -
Document: Start of procedure: Extension of marketing authorisation (26 June 2026 - 23 July 2026)-2026/7/31
2026-08-02查看详情 > -
国家药监局药审中心关于发布《注射用两性霉素B脂质体生物等效性研究技术指导原则》的通告(2022年第45号)-2022/11/25
2022-11-25查看详情 > -
国家药监局综合司关于同意上海市食品药品检验研究院增加生物制品批签发证明文件授权签发人的复函 药监综药管函〔2023〕584号-2023/11/8
2023-11-15查看详情 > -
Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology-2025/1/17
2025-01-17查看详情 > -
Page: Development of the Clinical Trials Information System-2025/2/20
2025-02-21查看详情 > -
Document: Day 80 assessment report - Non-clinical template with guidance Rev. 03.25 - Revamp-2025/3/28
2025-04-01查看详情 > -
Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - track changes-2025/5/6
2025-05-07查看详情 > -
Document: Questions and answers about the SEND proof-of-concept for industry: Scope, terms of participation and data submission process-2025/6/16
2025-06-17查看详情 > -
Document: PMS data matrix - Cross-platforms-2025/7/18
2025-07-21查看详情 >