India’s current regulatory architecture for approving novel treatments is ambiguous and assigns overlapping functions to different governmental bodies. Human germline editing and reproductive cloning are banned by the National Guidelines for Stem Cell Research, although there are no specific and enforceable laws. Research involving human germline gene therapy, reproductive cloning, and clinical trials involving “xenogeneic” […]
India: Germline / Embryonic Read More »
Gene therapy is allowed but requires approval from the Central Drugs Standard Control Organisation (CDSCO). Guidelines issued in 2019 establish a regulatory framework for gene therapy in an effort to standardize gene therapy product development and clinical trials. The guidelines require long-term follow up of at least five years for all clinical trials, and up
India: Therapeutic / Stem Cell Read More »
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
Southeast Asia: Germline / Embryonic Read More »
No information at this time.
Southeast Asia: Therapeutic / Stem Cell Read More »
No laws specifically regulate gene therapies, but they are regulated through existing medical drug laws. The Ministry of Health is responsible for overseeing clinical trials and medical drug approval. Gene therapies also need to be approved by central and local ethics committees. Stem cell treatments must be administered by certified medical centers that are accredited
Russia: Therapeutic / Stem Cell Read More »
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
Russia: Germline / Embryonic Read More »
Gene therapy is not explicitly regulated, but new biotechnology drugs are regulated by the General Health Law, which includes safety and efficacy assessments. Until more specific regulations are developed, gene therapy would be considered a new biotechnology drug, which is defined as any substance produced by molecular biotechnology that has a therapeutic effect. Applicants for
Mexico: Therapeutic / Stem Cell Read More »
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
Mexico: Germline / Embryonic Read More »
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
Japan: Germline / Embryonic Read More »
Gene therapy is permitted and approval can be fast-tracked through an accelerated system that is unique to Japan. After short, small clinical trials for safety and effectiveness, regenerative medicines (therapies that repair tissues and organs, including gene therapy) can be approved on a conditional basis that allows for the marketing, sale, and use of the
Japan: Therapeutic / Stem Cell Read More »
Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.
Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.
To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.
For more background on the various gene editing SDN techniques, read background articles here and here.