TFDA ANNOUNCED THE CRITERIA FOR CLINICAL TRIAL TO STRENGTHEN DOMESTIC SOMATIC CELL-BASED THERAPEUTIC PRODUCTTo ensure the clinical trial of somatic cell therapy complying with the scientific standard, safety, and social ethics, as well as to protect the participants’ right, the Taiwan Food and Drug Administration, Department of Health (hereinafter TFDA) officially announced draft version of “the Criteria for Clinical Trial of Somatic Cell Therapy” (hereinafter the Draft), several months ago this year. In addition to regulating the stem cell-based treatments, the Draft also requested all related project leaders to follow the rules while preparing documents for the application of clinical trial…
國內法規動向觀察與評析 (3)