Issue Date: July 24, 2017
Issued by: Center for Biologics Evaluation and Research
Topic(s): ICH-Multidisciplinary
Status: Final
M4E(R2): The CTD – Efficacy
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 or Agency). A common format for technical documentation significantly reduces the time and resources needed to compile applications for registration of human pharmaceuticals by eliminating the need for applicants to reformat data and information for submission to multiple regulatory authorities. This harmonization facilitates regulatory reviews, efficient communication between regulators and applicants, as well as the efficient exchange of information between regulatory authorities.
Download the Guidance Document
