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Development and manufacture of human medicinal products specifically designed for phage therapy - Scientific guideline-2023/12/22
2024-01-03查看详情 > -
Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) - Scientific guideline-2023/12/19
2023-12-21查看详情 > -
ICH E6 (R2) Good clinical practice - Scientific guideline-2023/12/19
2023-12-21查看详情 > -
Page: Regulatory requirements for the development of medicinal products for Acute Kidney Injury (AKI) - Scientific guideline-2023/12/18
2023-12-21查看详情 > -
Page: Assessment of SmPC section 5.1: A Guide for Assessors of Centralised Applications - Scientific guideline-2023/12/18
2023-12-21查看详情 > -
Page: Calculation of dose factor to be submitted to the Union Product Database (UPD) - Scientific guideline-2023/12/15
2023-12-21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: Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)-2023/12/6
2023-12-21查看详情 > -
Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)-2023/11/21
2023-11-23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 (updated)-2023/11/13
2023-11-15查看详情 >
