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关于公开征求《药品追溯系统基本技术要求(修订征求意见稿)》意见的通知-2026/8/3
2026-08-04查看详情 > -
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals (Final)-2022/11/2
2022-11-30查看详情 > -
Draft Guidance: Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act-2023/5/17
2023-05-18查看详情 > -
国家药监局关于连花清咳片等3种处方药转换为非处方药的公告(2023年第145号)-2023/11/22
2023-11-23查看详情 > -
国家药监局关于同意成都市药品检验研究院作为锝标记及正电子类放射性药品检验机构的通告(2025年第5号)-2025/1/15
2025-01-17查看详情 > -
Page: Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Scientific guideline-2025/2/21
2025-02-24查看详情 > -
Document: Draft guideline on the quality aspects of mRNA vaccines-2025/3/31
2025-04-01查看详情 > -
关于公开征求《抗肿瘤药物生物等效性及药代动力学比对研究受试者人群选择考虑(征求意见稿)》意见的通知-2025/5/7
2025-05-08查看详情 > -
化妆品监督管理问题解答(七)-2025/6/17
2025-06-18查看详情 > -
Document: Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) - Revision 2-2025/7/21
2025-07-22查看详情 >