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Search results (330)
Overview of comments received on 'Paracetamol oral use immediate release formulations product-specific bioequivalence guidance' (EMA/CHMP/356877/2022 Rev.1)
English (EN) (510 KB - PDF)
Overview of comments received on 'Draft guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - first version'
English (EN) (2.64 MB - PDF)
Overview of comments received on 'Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance’ (EMA/CHMP/559889/2021) - Rev. 1
English (EN) (528.66 KB - PDF)
Overview of comments received on Concept paper on the development of a guideline on determination of the need for an MRL evaluation for biological substances
English (EN) (274.32 KB - PDF)
Overview of comments received on Draft guideline on plasmid DNA vaccines for veterinary use
English (EN) (287.55 KB - PDF)
Overview of comments on ICH E6 (R3) guideline
English (EN) (1.72 MB - PDF)
Overview of comments received on 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
English (EN) (376.72 KB - PDF)
Overview of comments received on Guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD) (EMA/CVMP/PhVWPV/399363/2023)
English (EN) (421.44 KB - PDF)
Overview of comments received on 'Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers' (EMA/CHMP/83033/2023)
English (EN) (459.51 KB - PDF)
Overview of comments received on the 'Reflection paper on the environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs'
English (EN) (730.21 KB - PDF)