ICH Project ICH M8 (Electronic Application Form) Step 2 Implementation Guide Briefing Session
March 26, 2015
For M8 eCTD, the ICH M8 Expert Working Group has been working on the implementation of its next generation major revision (eCTD v4.0), and now the M8 eCTD v4.0 Implementation Guide has reached Step 2. The Regulatory Science Foundation for Pharmaceuticals and Medical Devices and the Japan Pharmaceutical Manufacturers Association ICH Project took this opportunity to hold a briefing session to promote understanding and awareness of the requirements of the Step 2 Implementation Guide. In light of the trend of digitization in Japan, we will also explain the measures to be taken to make it mandatory.
The Ministry of Health, Labor and Welfare (MHLW) issued a request for comments on the Step 2 Implementation Guide on March 2, 2015.
More than 150 people from the pharmaceutical industry and other related parties attended the briefing, which was followed by a lively question-and-answer session.
In order to further deepen your understanding, we have also prepared the following related reference materials as supplements to this briefing. Please take advantage of these materials.
Please note that the contents of the attached materials may not be copied or reproduced on this website without prior permission.
Japan Regional Implementation Guide (Draft) (English Translation) (668KB)
This document was voluntarily translated into English by the JPMA ICH M8 Expert Working Group in the hope that it will serve as a supplemental material to deepen understanding of the original "Draft Implementation Guide for Japan" (Japanese). If there are any discrepancies between this English translation and the original, the original shall prevail. The original document can be viewed on the MHLW website.
Test Tool User Manual (2047KB)
Date, Time, and Location
| Date and Time | Location |
|---|---|
| March 9, 2015 (Monday) 10:00-17:00 | Tower Hall Funabori Main Hall |
Information, Program
Information and Program (279KB)
Lecture Materials
| Presentations | Speakers |
|---|---|
| Naruhiko Hiramoto (Pharmaceuticals and Medical Devices Agency) | |
| Masahiro Uchino (Pharmaceuticals and Medical Devices Agency) | |
| Taku Watanabe (Pharmaceuticals and Medical Devices Agency) | |
| 04_ICH M8 Step 2 Implementation Guide Technical Details (1200KB) | Taku Watanabe (Pharmaceuticals and Medical Devices Agency) |
| 05_ICH M8 Step 2 Implementation Guide Q&A | Taku Watanabe (Pharmaceuticals and Medical Devices Agency) |
| 06_ICH M8 Step 2 Implementation Guide Explanation of Test Tools（1532KB) | Taku Watanabe (Pharmaceuticals and Medical Devices Agency) |
| Kayoko Ichikawa (Japan Pharmaceutical Manufacturers Association, ICH Project M8 Expert) |