Here begins the text.

Outcome Documents of the Science Board

The Fourth Term (-March, 2020) Subcommittees

  • Genome editing, an innovative technique, may cause alterations in genes other than the target gene (off-target effects) or unexpected mutations in the target gene (on-target mutations), and these mutations need to be evaluated.

The Science Board has prepared a report summarizing the issues to be considered in the development of gene therapy products using genome-editing technology.

White-paper for quality and safety for gene therapy products using gene editing technology


The article explaining the basis and comparison of the key concepts with information provided by foreign regulatory authorities has now been published in the paginated issue:

Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan (Human Gene Therapy, Volume 31, Issue 19-20, 1043-1053, 2020)


The Third Term (-March, 2018) Subcommittees




The Second Term (-March, 2016) Subcommittees


The First Term (-March, 2014) Subcommittees

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

  • Contact us
  • Access/Map

Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved.

Outcome Documents of the Science Board