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Search results (3270)
CHMP reflection paper on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Revision 3
English (EN) (615.83 KB - PDF)
ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b
English (EN) (1.48 MB - PDF)
Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMP
English (EN) (275.49 KB - PDF)
Overview of comments received on Implementation strategy of ICH Guideline M10 on bioanalytical method validation EMA/449486/20233
English (EN) (301.47 KB - PDF)
Implementation strategy of ICH Guideline M10 on bioanalytical method validation
The purpose of this document is to address specific considerations to enable the practical implementation of ICH Guideline M10 on bioanalytical method validation in the European Union. The comments received in the public consultation that ended 31 January 2024 have been published
English (EN) (276.13 KB - PDF)
Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence
English (EN) (408.25 KB - PDF)
Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure
English (EN) (240.94 KB - PDF)
Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products
English (EN) (298.63 KB - PDF)
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling
English (EN) (399.77 KB - PDF)
Overview of comments received on Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure
English (EN) (103.35 KB - PDF)