Issue Date: August 1, 2001
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Multidisciplinary
Status: Final
M4: The CTD — Quality
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 Quality section of the CTD for applications that will be submitted to regulatory authorities. A common format for the technical documentation will significantly reduce the time and resources used 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 among regulatory authorities will be simplified.
Download the Guidance Document
