ICHPharmaceutical Regulations in Japan

Workshop on the ICH M8 (eCTD v4.0 )(JPMA, Nihonbashi Life Science Building, Tokyo)

The Workshop on the ICH M8 Guideline was held in Japan which took place at JPMA Building in Tokyo on August 8, 2017.
ICH M8 has continued a discussion on a new electronic specification of eCTD in order to harmonize in ICH. eCTD v4.0  specification was reached to step2 in November 2014 and step4 in December 2015. ICH eCTD v4.0 implementation Guide has been published on ESTRI page of ICH web site.
Notifications which will be implemented in Japan of eCTD v4.0 have been published in July 5th, 2017.
This workshop aimed to provide the explanation of eCTD v4.0 Implementation Guide from PMDA and JPMA in order to promote understanding a new specification for eCTD. The suggestion that what a pharmaceutical company should do before implementation of eCTD v4.0 was also provided.
The workshop was organized by the Japan Pharmaceutical Manufacturers Association (JPMA). All the information as well as the presentation used at the workshop in Japanese is available as below.
Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available
None of this publication may be reproduced by any means without the prior permission of the copyright owner.
Program Chair: Kayoko Ichikawa, Akiyo Fujikawa, Ryoichi Hiruma, Hitoshi Matsui (JPMA)

Location: Nihonbashi Life Science Building (JPMA) 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo
August 8, 2017  1:30 pm ~4:30 pm

  Presentation Title Speakers
13:30-13:35 Opening remarks Hironobu Hiyoshi, JPMA
13:35-14:25 For successfully implementation of eCTD v4.0 in Japan. (PDF 1819KB) Taku Watanabe, PMDA
14:40-15:15 Key-points of understanding eCTD v4.0 notifications by pharmaceutical company. (PDF 1653KB) Kayoko Ichikawa, JPMA
15:15-15:35 Adaption to eCTD v4.0 in pharmaceutical company.(PDF 475KB) Ryoichi Hiruma, JPMA
15:55-16:25 Q&A Session M8 EWG/IWG Members
16:25-16:30 Closing Remarks Masafumi Yokota, JPMA

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