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Scientific guideline: Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy studies-2023/7/31
2023-08-02查看详情 > -
Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes-2023/7/25
2023-07-28查看详情 > -
Regulatory and procedural guideline: Guidance document on voting in the framework of discussion and adoption of CHMP opinions-2023/7/26
2023-07-28查看详情 > -
Regulatory and procedural guideline: Compilation of Union procedures on inspections and exchange of information-2023/7/13
2023-07-21查看详情 > -
Guidance on good manufacturing practice and good distribution practice: Questions and answers-2023/7/13
2023-07-21查看详情 > -
ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline-2023/7/19
2023-07-21查看详情 > -
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure-2023/7/5
2023-07-07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-2023/7/5
2023-07-07查看详情 > -
Scientific guideline: ICH reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of
2023-07-07查看详情 > -
Regulatory and procedural guideline: Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period-2023/7/3
2023-07-05查看详情 >