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Page: Clinical investigation of medicinal products in the treatment of peripheral-arterial occlusive disease - Scientific guideline-2026/1/27
2026-01-28查看详情 > -
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers-2026/3/3
2026-03-05查看详情 > -
Page: Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use - Scientific guideline-2026/4/1
2026-04-02查看详情 > -
Document: Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies-2026/5/18
2026-05-19查看详情 > -
Page: Plasma master file certificates-2026/7/1
2026-07-02查看详情 > -
Page: PRIME: priority medicines-2026/8/10
2026-08-11查看详情 > -
国家药监局综合司 海关总署办公厅关于增设石家庄航空口岸为药品进口口岸有关事宜的通知 药监综药注〔2022〕91号-2022/11/22
2022-11-30查看详情 > -
国家药监局关于实施《药物非临床研究质量管理规范认证管理办法》有关事宜的公告(2023年第81号)-2023/6/21
2023-06-21查看详情 > -
Document: Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)-2023/12/6
2023-12-21查看详情 > -
Document: Procedural advice for orphan medicinal product designation: Guidance for sponsors-2025/1/23
2025-01-23查看详情 >