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ICH E6 (R2) Good clinical practice - Scientific guideline-2023/5/26
2023-05-30查看详情 > -
ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline-2023/5/24
2023-05-25查看详情 > -
Guidance for industry to prevent and mitigate medicine shortages-2023/5/17
2023-05-18查看详情 > -
Regulatory and procedural guideline: Good practices for industry for the prevention of human medicinal product shortages-2023/5/17
2023-05-18查看详情 > -
Scientific guideline: Concept paper on revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome-2023/5/4
2023-05-05查看详情 > -
Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes -2023/4/25
2023-04-26查看详情 > -
Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes-2023/4/25
2023-04-26查看详情 > -
Pre-authorisation guidance-2023/4/25
2023-04-26查看详情 > -
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes-2023/4/25
2023-04-26查看详情 > -
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure-2023/4/25
2023-04-26查看详情 >