Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries.

Abstract

Autologous chondrocytes (ACs) are Human cell/tissue-based products used for the treatment of joint cartilage defects. Regulatory agencies have established regulations related to ACs to ensure their safety and efficacy. This study investigated the status and characteristics of ACs approved worldwide. Furthermore, the AC-related regulations were compared by country to provide reference materials for the development of product approval procedures. This study reviewed the current status of global AC