ICH Project Workshop on the ICH M8 eCTD v4.0 Step 2 Implementation Guide (Tower Hall Funabori, Tokyo)

March 09, 2015

The workshop on the ICH M8 eCTD v4.0 Step 2 Implementation Guide was held in Japan, which took place at the Tower Hall Funabori, Edogawa-ku in Tokyo on March 9, 2015.
The workshop was the first opportunity to provide the detailed explanation of ICH M8 eCTD v4.0 Step 2 Implementation Guide to the public. The M8 EWG plays a key role to assume responsibility for the continued development of the next major version of the eCTD (eCTD v4.0).
The workshop was open to the public, and over 150 participants including personnel concerned from pharmaceutical industries attended this workshop and had vigorous Q&A discussion.
This M8 implementation guide was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association.
All the presentations used at the workshop are available in Japanese as below.

ICH eCTD v4.0 Draft Japan Regional Implementation Guide (Translated in English)(668KB)

This document is an English translation of "Draft Japan Regional Implementation Guide" that was developed by courtesy of JPMA ICH M8 Expert Working Group in order to facilitate further understanding thereof. This is for your convenience only and, in the event of any discrepancy between this document and Japanese original document, the original shall prevail. Such Japanese original document is available at MHLW/PMDA web site.

Instruction manual for the test tools（2047KB）

Implementation Training Workshop