Gene therapy products may accidentally leak or shed during clinical use, thereby integrating the genetic material they carry into other non-patient populations or plants and animals, with adverse effects on ecosystems and human health. In order to reduce the environmental risks of gene therapy products, the United States and the European Union have formulated relevant laws and regulations and issued special guidelines, which stipulate the environmental risk assessment conduct, review and specific steps in the clinical trials and marketing registration of gene therapy products. At present, there are no specific regulations on the environmental risks of gene therapy products in China, it is suggested that China can learn from the relevant practices of the Europe and the USA, establishing gene therapy products environmental risk supervision laws and regulations system, and clarify the specific steps of environmental risk assessment; harmonizing the regulatory agencies and review procedures for gene therapy products registration and environmental risk assessment; establishing a scientific and reasonable basis for consideration of gene therapy products environmental risk assessment and take different regulatory measures according to the level of environmental risk of the product.