Table 1.

The laws and guidelines pertaining to medical research involving human participants that came in effect in Japan as of November 2021.

The law or guidelines	Year of establishment (the latest revision)
(1) Act on Securing the Quality, Efficacy, and Safety of Products, Including Pharmaceuticals and Medical Devices	1960 (2019)
(2) Act on the Regulation of Human Cloning Techniques (Note: The detailed regulations for some of the research activities referred to in this paper are provided in the Guidelines for the Handling of Specified Embryos, which was established under this law in 2001 and last revised in 2021.)	2000 (2014)
(3) Act on the Safety of Regenerative Medicine	2013 (2018)
(4) The Clinical Trials Act	2017 (2019)
(5) Ethical Guidelines for Medical and Biological Research Involving Human Subjects	2021 (2022)
(6) Guidelines for Gene Therapy Clinical Trial	2015 (2022)
(7) Guidelines on the Derivation of Human ES Cells	2014 (2022)
(8) Guidelines on the Utilization of Human ES Cells	2019 (2022)
(9) Guidelines for the Distributing Institute of Human ES Cells	2019 (2022)
(Note. The first guidelines for ESCs were established in 2001 and reorganized several times after that.)
(10) Ethical Guidelines for Assisted Reproductive Technology Research that Involves the Generation of Human Embryos	2010 (2022)
(11) Guidelines on the Research on Producing Germ Cells from Human iPS Cells or Human Tissue Stem Cells	2010 (2022)
(12) Ethical Guidelines for Research that Involves the Use of Technology to Modify Genetic Information in Human Embryos	2019 (2022)