ICH Project ICH M8 (Electronic Submission Forms) Step 2 Implementation Guide Briefing
March 26, 2015
Regarding the M8 eCTD, the ICH M8 Expert Working Group has been working toward the implementation of its next-generation major revision (eCTD v4.0), and the M8 eCTD v4.0 Implementation Guide has now reached Step 2.Taking this opportunity, the Pharmaceutical and Medical Device Regulatory Science Foundation (a general incorporated foundation) and the Japan Pharmaceutical Manufacturers Association (JPMA) ICH Project held a briefing session to promote understanding and raise awareness of the requirements outlined in the Step 2 Implementation Guide. In light of trends in Japan’s transition to electronic submissions, we also provided an explanation regarding preparations for the upcoming mandatory implementation.
Additionally, the Ministry of Health, Labor and Welfare issued a call for comments on the Step 2 Implementation Guide on March 2, 2015.
More than 150 stakeholders from the pharmaceutical industry and other related fields attended this briefing session, which featured a lively question-and-answer session.
Furthermore, to help you gain a deeper understanding, we have prepared the following related reference materials as supplementary resources for this briefing and are posting them here as well. Please make use of them.
Please note that unauthorized copying or reproduction of the attached materials posted on this website is prohibited.
Japan Regional Implementation Guide (Draft) (English Translation) (668KB)
This document is an English translation independently and voluntarily prepared by the JPMA ICH M8 Expert Working Group, with the aim of serving as supplementary material to facilitate a deeper understanding of the original “Japan Regional Implementation Guide (Draft)” (in Japanese). In the event of any discrepancies between this English translation and the original text, please refer to the original text.The original document is available on the Ministry of Health, Labour and Welfare website.
Test Tool User Manual (2047KB)
Date, Time, and Location
| Date and Time | Location |
|---|---|
| March 9, 2015 (Mon) 10:00 a.m.–5:00 p.m. | Tower Hall Funabori Main Hall |
Information and Program
Event Information and Program (279 KB)
Lecture Materials
| Presentation | Speakers |
|---|---|
| Shigehiko Hiramoto (NIH) | |
| Masahiro Uchino (NIH) | |
| 03_Overview of the ICH M8 Step 2 Implementation Guide (797 KB) | Taku Watanabe (NIH) |
| 04_Technical Details of the ICH M8 Step 2 Implementation Guide (1200KB) | Taku Watanabe (NIH) |
| 05_ICH M8 Step 2 Implementation Guide: Q&A | Taku Watanabe (NIH) |
| 06_ICH M8 Step 2 Implementation Guide: Explanation of Testing Tools (1532KB) | Taku Watanabe (NIH) |
| 07_Explanation of the Tool: Introduction to the “Test Tool User Manual” (697 KB) | Kayoko Ichikawa (Japan Pharmaceutical Manufacturers Association, ICH Project M8 Expert) |