Background

On September 6, 2018, the Ministry of Health and Welfare issued the amended articles of the "Regulations Governing the Application of Specific Medical Technique and Medical Device", approving cell therapy technologies. The applicable cell therapy technologies include but are not limited to autologous immune cell therapy for cancer patients who have proven unresponsive to standard treatments and patients with advanced solid cancers, autologous chondrocyte therapy for cartilage defects of the knee, and autologous adipose tissue-derived stem cell (ADSC) therapy for a large area of burns and hard-to-heal wounds. The CDE is entrusted by the Ministry of Health and Welfare to conduct cell therapy technology reviews.