25 November 2014

Notice is hereby given that The Ministry of Education, Culture, Sports, Science and Technology has announced in today’s Official Gazette (25 November) that it has compiled ‘Guidelines on the Derivation of Human Embryonic Stem Cells’ and the ‘Guidelines on the Distribution and Utilization of Human Embryonic Stem Cells’ pertaining to points of compliance in the clinical utilization of human embryonic stem cells.

Background

While it is anticipated that human embryonic stem cells, which have the ability to differentiate into various types of cells, will be used in medical care, bioethical issues have also been identified, since their derivation involves the destroying of embryos as the emerging potential of human life.

Accordingly, in 2001 the Ministry of Education, Culture, Sports, Science and Technology adopted guidelines which provided an appropriate promotion for basic research into human embryonic stem cells.

In November 2013, the ‘Act on the Safety of Regenerative Medicine’ was established, which provided a legal framework for clinical application of human embryonic stem cells.

In response to this, new guidelines were drawn up regarding points of compliance as far as clinical utilization, and drafts of these were submitted to the Council for Science, Technology and Innovation for consultation. On 17 November, a response was received from the council indicating its support for the proposed drafts, and in today’s Official Gazette (25 November), the Ministry of Education, Culture, Sports, Science and Technology gave public notice of the implementation of the ‘Guidelines on the Derivation of Human Embryonic Stem Cells’, and ‘Guidelines on the Distribution and Utilization of Human Embryonic Stem Cells’.

 

Documentation

‘Guidelines on the Derivation of Human Embryonic Stem Cells’ (Ministry of Education, Culture, Sports, Science and Technology / Ministry of Health, Labour and Welfare Public Notice No. 2, 2014)
(※link to ‘Ministry of Education, Culture, Sports, Science and Technology, LifeScience Portalsite’)


‘Guidelines on the Distribution and Utilization of Human Embryonic Stem Cells’ (Ministry of Education, Culture, Sports, Science and Technology / Ministry of Health, Labour and Welfare Public Notice No. 174, 2014)
(※link to ‘Ministry of Education, Culture, Sports, Science and Technology, LifeScience Portalsite’)

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(Administrator of Bioethics,Office for Bioethics and Biosafety,Life Sciences Division,Research Promotion Bureau)