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M4 Step 5 CTD for the registration of pharmaceuticals for …

M4 Step 5 CTD for the registration of pharmaceuticals for …

www.ema.europa.eu

common format for the technical documentation will significantly reduce the time and resources ... guidance regarding the format and content of the New Drug Application. To avoid the need to generate ... General principles Throughout the Common Technical Document, the display of information should be unambiguous and

  Applications, Principles, Common, Format, Common format

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