首页 >
法规速递
-
Document: Agenda of the CHMP meeting 10-13 November 2025-2025/11/10
2025-11-11查看详情 > -
Document: Medicine shortage communication (MSC): Insulin lispro Sanofi (insulin lispro 100 units/ml solution for injection in cartridge and pre-filled pen)-2025/12/8
2025-12-09查看详情 > -
中药保护品种公告（第34号）（2026年第11号）-2026/1/20
2026-01-21查看详情 > -
Page: ICH Q2(R2) Validation of analytical procedures - Scientific guideline-2026/2/20
2026-02-27查看详情 > -
Page: Eltrombopag product-specific bioequivalence guidance-2026/3/25
2026-03-26查看详情 > -
Document: Meeting summary - Medicine Shortages SPOC Working Party meeting 16-17 March 2026-2026/5/4
2026-05-06查看详情 > -
关于公开征求《国外原研企业在中国境内生产的药品上市许可持有人变更后可遴选为参比制剂的情形（征求意见稿）》和《国外原研企业在中国境内生产的药品上市许可持有人变更后参比制剂申请资料要求（征求意见稿）》意见的通知-2026/6/16
2026-06-17查看详情 > -
Multiple Endpoints in Clinical Trials Guidance for Industry (Final)-2022/10/21
2022-11-15查看详情 > -
Regulatory and procedural guideline: Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group-2023/4/19
2023-04-24查看详情 > -
国家药监局综合司公开征求《药品监督管理行政处罚裁量适用规则（征求意见稿）》意见-2023/10/19
2023-11-06查看详情 >
