Why is a Japanese DMF important?

A Japanese Drug Master File (DMF) is crucial because it provides confidential information about the manufacturing, quality, testing, and safety of pharmaceutical ingredients for either APIs, excipients, or drug packaging materials to the Japanese regulatory authorities. This enables pharmaceutical companies to seek... Read More


How Do You Submit a DMF in China?

To submit a Drug Master File (DMF) in China, you must prepare a comprehensive application package in accordance with Chinese regulatory requirements, including administrative information, detailed drug component information, quality data, manufacturing processes, stability data, safety information, change control information, and container... Read More