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Document: Marketing authorisation application (MAA) - pre-submission interactions form-2025/7/23
2025-07-24查看详情 > -
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes-2025/9/8
2025-09-09查看详情 > -
Document: ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5-2025/10/10
2025-10-11查看详情 > -
Page: Scientific advice and protocol assistance-2025/11/17
2025-11-18查看详情 > -
Page: Stability testing for applications for variations to marketing authorisation - Scientific guideline-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Supriya Lifescience Ltd.马来酸氯苯那敏原料药的公告(2026年第14号) -2026/1/26
2026-01-27查看详情 > -
Document: Darwin EU study: Background incidence rates of selected vaccine adverse events of special in Europe-2026/3/4
2026-03-05查看详情 > -
Page: Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline-2026/3/31
2026-04-01查看详情 > -
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect-2026/5/13
2026-05-15查看详情 > -
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus-2026/6/29
2026-06-30查看详情 >