Germline / Embryonic

Countries in Southeast Asia have not determined the regulatory status of germline gene editing. There is little research and no products in development. Products/Research None Regulatory Timeline None NGO Reaction None Additional Resources Genetic Literacy Project’s FAQ on gene editing

Russia has no explicit regulations directly addressing the germline gene editing of embryos for research or clinical purposes, but supports the World Health Organization position against making changes to the human germline. Russia is not party to the 1997 European-based Oviedo Convention, which bans modifying the human germline. There are laws that prohibit human genetic engineering

Germline gene editing is not explicitly regulated, but a law from 1997 prohibits the fertilization of human eggs for any purposes other than reproduction. This has been interpreted as prohibiting the use of embryos for research, including gene editing. The Ministry for Health is responsible for regulating human gene editing research. The General Law on

Japan’s germline gene editing regulations are looser than in most of the world, but still restricted. Draft guidelines issued in 2018 allow for gene editing of human embryos for research to treat genetic diseases. The guidelines restrict germline gene editing for reproductive purposes and clinical testing but violations are not punishable by law. The guidelines

Germline gene editing “for the purpose of creating humans” is banned and can be punishable with up to four years imprisonment or fines under the Prohibition of Genetic Intervention Law, passed in 1999 and since renewed multiple times by the Israeli Parliament. However, the Minister of Health may give permission for germline gene editing experiments,

Gene editing research in human embryos is permitted, but requires a license from the Human Fertilisation and Embryology Authority (HFEA). Gene editing for reproductive purposes is illegal. In 2016, HFEA permitted the first sanctioned studies applying CRISPR to human embryos, although scientists are permitted to only study embryos for research purposes and are prohibited from

Germline gene editing research is allowed, but establishing a pregnancy with a genetically engineered embryo is prohibited under multiple regulations. Gene editing requires approval by an ethics committee of a hospital or IVF clinic, but approval from national regulatory agencies is not required. Research ethics committees are responsible for ensuring compliance by performing ethical review

Germline gene editing for clinical purposes is banned, but it is unclear whether this ban applies to germline gene editing research. Germline editing is regulated by the EU Commission, the European Medicines Agency (EMA) and the Federation of European Academies of Medicine (FEAM). In 2014, the EU Clinical Trials Regulation banned any gene therapy clinical

Germline gene editing is banned by a resolution and a law. The CNS Resolution #340, finalized in 2004, allows human genetic research on somatic (adult) cells only. In 2005, Law No. 11.105 was passed, which bans genetic engineering in “human germinal cells, human zygotes and human embryos”. However, the law primarily focuses on regulating genetically