首页 >
法规速递
-
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs-2025/12/15
2025-12-16查看详情 > -
Page: Questions and answers on how to use a CEP in the context of a Marketing Authorisation Application or a Marketing Authorisation Variation-2026/1/28
2026-01-29查看详情 > -
中药保护品种公告(第35号)(2026年第22号)-2026/3/9
2026-03-10查看详情 > -
Document: CHMP PROM minutes for the meeting on 12 May 2025-2026/4/7
2026-04-08查看详情 > -
Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein-2026/5/21
2026-05-22查看详情 > -
Page: Variations requiring assessment (veterinary medicines)-2026/7/3
2026-07-06查看详情 > -
Document: Annex 2 - Observational long-term safety surveillance registry studies in the Big MS Data (BMSD) network-2026/8/12
2026-08-13查看详情 > -
国家药监局药审中心关于发布《中药新药用于慢性胃炎的临床疗效评价技术指导原则(试行)》《中药新药用于胃食管反流病的临床疗效评价技术指导原则(试行)》的通告(2022年第47号)-2022/12/21
2022-12-22查看详情 > -
国家药监局综合司公开征求《药品检查管理办法(试行)》部分条款修订意见-2023/6/30
2023-06-30查看详情 > -
Draft Guidance: Quality Considerations for Topical Ophthalmic Drug Products-2023/12/27
2024-01-03查看详情 >