ICH: M 4: Common technical document for the registration of pharmaceuticals for human use: Organisation of CTD

Current effective version PDF iconICH: M 4: Common technical document for the registration of pharmaceuticals for human use: Organisation of CTD
Reference numberCPMP/ICH/2887/99
Published16/04/2007
DescriptionThis guideline presents the agreed upon common format for the preparation of a well-structured common technical document for applications that will be submitted to regulatory authorities. A common format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will ease the preparation of electronic submissions.


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