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Document: QRD Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page)-2026/3/25
2026-03-26查看详情 > -
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application-2026/5/5
2026-05-06查看详情 > -
Document: Products Management Services (PMS) public API - Terms and conditions-2026/6/12
2026-06-15查看详情 > -
国家药监局关于发布YY 0830—2011《浅表组织超声治疗设备》等4项医疗器械行业标准修改单的公告（2026年第68号）-2026/7/24
2026-07-26查看详情 > -
ANDA Submissions – Prior Approval Supplements Under GDUFA (Final)-2022/10/14
2022-11-15查看详情 > -
于发布《与恶性肿瘤治疗相关中药新药复方制剂临床研发技术指导原则（试行）》的通告(2023年第30号)-2023/4/14
2023-04-14查看详情 > -
国家药监局药审中心关于发布《无参比制剂品种开展仿制研究的技术要求和申报资料要求（试行）》《无参比制剂品种开展仿制研究的沟通交流申请资料要求（试行）》的通告（2023年第52号）-2023/10/13
2023-10-13查看详情 > -
Page: Guideline on quality aspects of mRNA vaccines for veterinary use-2025/1/8
2025-01-09查看详情 > -
Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs)-2025/2/14
2025-02-18查看详情 > -
Page: Type-IB variations: questions and answers-2025/3/25
2025-03-26查看详情 >
