Drug Evaluation Committee Guidance for Preparation of Electronic Common Technical Document (eCTD) (Version 4.1 English translation) Published: October 7, 2016

Electronic Information Subcommittee

October 2016

With the increasing globalization of drug development, eCTDs need to be mutually understood in Japan, the U.S., and Europe. In addition, eCTD is now accepted in Thailand and GCC countries.
Against this backdrop, it has become necessary for people overseas to understand the overview of eCTD in Japan and the process from eCTD creation to approval.
Therefore, we have translated Part 2 (from preparation to approval of eCTD) of the eCTD Preparation Guide (Version 4.1) into English. Some parts, such as those not directly related to eCTD, have been omitted from the translation, but the section numbers have been retained for the convenience of comparison with the Japanese version (original).
We hope that this document will be of use to foreign parties in your company to help them understand the Japanese eCTD and the process from preparation to approval of the eCTD.

Guide to the Preparation of Electronic Common Technical Documents (eCTD) Version 4.1 English translation (published October 2016) (1.8MB)

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