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This guidance primarily addresses the organization of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived and biological products).
This guidance is not intended to indicate what studies are required. It merely indicates an appropriate format for the data that have been acquired. Applicants should not modify the overall organization of the CTD as outlined in the guidance. However, in the Nonclinical and Clinical Summaries, applicants can modify individual formats if needed to provide the best possible presentation of the technical information, in order to facilitate the understanding and
evaluation of the results.

 

M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use