ICH: M 4: Common technical document for the registration of pharmaceuticals for human use: Organisation of CTD - Scientific guideline
HumanScientific guidelines
This 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.