Regulatory Challenges in Cartilage and Osteochondral Products
摘要
Osteochondral tissue engineered products, which fall under the broad category of Advanced Therapy Medicinal Products (ATMPs), promote cartilage regeneration either by replacing damaged cartilage or stimulating endogenous repair processes, thereby restoring dysfunctional cartilage tissue to achieve normal structural and functional integrity. These products typically integrate cells subjected to induced differentiation, in vitro expansion, or genetic modification, combined with materials for medical devices through advanced manufacturing techniques like additive manufacturing of biomedical materials, micro-nano structure fabrication, or micro-nano fluidics. Osteochondral tissue engineered products amalgamate three medical product categories-cells and biological factors, drug substances, and biomedical materials-which have historically been regulated under separate frameworks. Consequently, from pre-market access to post-market surveillance, these products face regulatory challenges from three distinct medical product categories. Regulatory authorities are also challenged to enhance efficiency and scientific rigor in addressing the demands of these novel products and emerging industrial models. This chapter provides a life cycle-based overview of China’s regulatory understanding of osteochondral tissue engineered medical products, particularly when such products are primarily classified as medical devices, drawing on regulatory experiences from developed markets such as Europe and the United States.