This is one in a series of guidances that provide recommendations for applicants preparing the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission to the U.S. Food and Drug Administration (FDA). This guidance 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. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. In addition, exchange of regulatory information between regulatory authorities will be simplified.
This guidance replaces two FDA guidance documents, the 2001 guidance for industry M4 Organization of the CTD and the 2005 Granularity Document Annex to M4 Organization of the CTD. This merger reflects the 2002 addition of the Annex: Granularity Document into the Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use.
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry