Therapeutic / Stem Cell

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 […]

No information at this time.

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

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

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

Gene therapy is permitted, but must be approved by a human research advisory committee and  a dedicated advisory committee (made up of physicians, scientists, regulators and ethics experts) and must follow regulations outlined in the Genetic Information Law. The creation of embryos specifically for stem-cell research is banned, but researchers can use embryos left over

Gene therapy is permitted, but clinical trials require a license from the Medicines and Healthcare products Regulatory Agency (MHRA) as well as oversight from the Human Tissue Authority (HTA) and the Health Research Authority (HRA). Gene therapy is an experimental technique that uses genes to allow doctors to treat or prevent a disorder by inserting

Gene therapy is allowed and clinical trials only require approval by an ethics committee of a hospital. Approval from national regulatory agencies is not required. Research ethics committees are responsible for ensuring compliance by performing ethical review of their institutions’ biomedical research activities involving human research participants. However, there is uncertainty about whether these regulations

Gene therapy is permitted but must comply with clinical trial regulations, the EU Commission Regulation on advanced therapy medicinal products, and the European GMO Directive, written in 2001, that outlines regulations for organisms altered through genetic modification. Requirements include environmental risk assessments and assessments on the potential adverse effects on human health. In addition, the

In 2019, a measure was approved by the Brazilian Health Regulatory Agency (Anvisa) to regulate gene therapy as a drug and to establish specific criteria for clinical studies using gene therapy. Because the measure clarified the approval process for gene therapy research, it is expected to increase gene therapy research being conducted. Additional legislation is