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Document: Draft qualification opinion for Simcyp Simulator-2025/5/8
2025-05-09查看详情 > -
国家药监局药审中心发布《中国新药注册临床试验进展年度报告（2024年）》-2025/6/19
2025-06-20查看详情 > -
Document: New fee regulation: General questions and answers for all applicants-2025/7/23
2025-07-24查看详情 > -
《中药生产监督管理专门规定》 政策解读-2025/9/8
2025-09-09查看详情 > -
Document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products-2025/1
2025-10-11查看详情 > -
Page: Parallel scientific advice and special development aspects or product types-2025/11/17
2025-11-18查看详情 > -
Document: Guideline on stability testing for applications for variations to a marketing authorisation - Revision 3-2025/12/12
2025-12-15查看详情 > -
国家药监局关于暂停进口、销售和使用Sun Pharmaceutical Industries Limited重酒石酸卡巴拉汀胶囊的公告（2026年第12号） -2026/1/26
2026-01-27查看详情 > -
Document: Minutes of the CAT meeting 21-23 January 2026-2026/3/4
2026-03-05查看详情 > -
Document: Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension-2026/3/31
2026-04-01查看详情 >
