The IPEC-Americas Excipient Master File Guide

Currently the only drug master file (DMF) systems that exist to handle the submission of confidential excipient information to support drug applications are in the United States and Canada. The European Union and Japan do not have such systems for excipients. The International Pharmaceutical Excipients Council (IPEC) is developing a global master file guide to meet the industry’s need to submit confidential excipient information. The format for the guide will be coordinated and harmonized with the electronic International Committee on Harmonization (ICH) common technical document (CTD) for presenting chemistry, manufacturing, and controls and safety information (1,2). This system will accelerate the process for submitting information globally because a confidentiality agreement between a DMF holder and a drug application sponsor will not be needed.

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