EMEA: Reflection paper Non-clinical and clinical development of similar medicinal products containing recombinant interferon alpha

This product specific reflection paper presents the current view of the CHMP on the non-clinical and clinical data for demonstration of comparability of two recombinant, non-pegylated, Interferon alfa containing medicinal products and should be read in conjunction with the requirements laid down in the EU Pharmaceutical legislation and other relevant CHMP guidelines (see References).

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Narodowe Centrum Badań i Rozwoju

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