[News] The Executive Yuan will pass the "Regulations on the Administration of Regenerative Medical Preparations"

The Executive Yuan will pass the "Regulations on the Management of Regenerative Medical Preparations" to ensure product safety and efficacy, and then conditionally market as a standard, issue conditional time permits, shorten the time-to-market of products, and make life-threatening and serious losses. Patients with disease can receive treatment in advance. He Qigong, the deputy head of Weifu, said that some patients have urgency. At this stage, there is no other medical technology to treat, and hope that those who need it can try new preparations early.

Wei Fu pointed out that in view of the international approval of regenerative medical preparations such as cell or gene therapy, China has also listed regenerative medicine as one of the key points of the biomedical industry innovation promotion program. Therefore, considering the heterogeneity of the regenerative medical preparations, the specificity of the process and Treatment complexity, risk management and control are different from traditional medicines. The current regulations cannot fully cover the application. It is necessary to formulate a special law in addition to the Pharmaceutical Affairs Law. Therefore, it is proposed to draft the Regulations on Regenerative Medical Preparation Management.

He Qigong pointed out that at present, the international new biological preparation therapy is booming, and there are many patients whose diseases are urgent. If there is no other medical technology to be treated at this stage, when the regenerative medical preparation products complete the third clinical trial, the time will be Very long, I hope that this bill will allow patients in need to try new preparations early, but this condition requires permission to switch to regenerative medical products, and also hopes that international regenerative medical biologics can be introduced into Taiwan.

He Qigong takes products approved by Japan as an example. For example, autologous skin cells can target severe burns, autologous chondrocytes can be used for wound cartilage damage and isolated osteochondritis. These two methods can be applied to medical equipment licenses. Marketed; and allogeneic mesenchymal stem cells can target acute graft versus host response (GVHD), autologous skeletal muscle fibroblasts can cause severe heart failure and other diseases caused by ischemic heart disease, these two are applicable to the new method, respectively Generally approved for listing and obtaining a conditional period permit.

Executive Council spokesperson Kolas Yotaka (Turkey Yodaka) told reporters at the press conference after the conference that Lai Qingde’s decision pointed out that in response to the booming trend of emerging international biotechnology, and regenerative medicine as “five plus two industries” One of the key points of the biomedical industry innovation promotion program is that the bill can promote the development of the regenerative medicine field, ensure the quality, safety and effectiveness of regenerative medical preparations, and safeguard the patient's treatment rights. The Department of Health and Welfare actively communicates with the Legislative Yuan and completes the legislative process as soon as possible.