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Document: ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 5-2024/1/3
2024-02-05查看详情 > -
ICH E6 (R2) Good clinical practice - Scientific guideline-2023/12/22
2024-01-03查看详情 > -
ICH Q2(R2) Validation of analytical procedures - Scientific guideline-2023/12/22
2024-01-03查看详情 > -
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 >
