Drug Evaluation Committee Guide to the Preparation of Electronic Common Technical Documents (eCTD) (Edition 4.1 English translation) Published: October 7, 2016

Electronic Standard for Medical Information Expert Committee

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 outline 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 you will use this document to help your overseas colleagues 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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