关键词: 类器官, 器官芯片, 监管政策, 十五五规划

Abstract:

Organoids are a three-dimensional (3D) in vitro culture technology developed in recent years, in which a portion of living tissue is expanded and passaged in a 3D culture medium to generate miniature organs. Organoids share a high degree of similarity with their parental tissues in terms of cellular composition, biological functions, genomic variation profiles, and drug sensitivity. Organoids have a short preparation cycle and can still be used after long-term cryopreservation and recovery, and are therefore referred to as "living biobanks". Organ-on-chip, also known as organoid chip, is a microphysiological system (MPS) that integrates organoid construction with microfluidic chips or microplate technology, in which organoids are seeded onto microfluidic devices or microplates, and can serve as a novel experimental model for drug sensitivity analysis and drug screening. Organoids and organ-on-chip have broad application prospects in histogenesis, disease pathogenesis, compound toxicology, response to drug treatment, and high-throughput drug screening. Tumor research is an important application area for organoids and organ-on-chip. In recent years, countries in Europe and the United States have introduced a series of policies and regulations to promote the application of organoids and organ-on-chip, aiming to gradually reduce reliance on experimental animals in scientific research and drug development. The Ministry of Science and Technology of China and the National Natural Science Foundation of China have also identified the construction and application of organoid models as an important funding direction. With the continuous improvement of regulatory policies related to organoids, the healthy and orderly development of organoid-related technologies in China will be further promoted.

Key words: Organoids, Organ-on-chip, Regulatory policy, The 15th Five-Year Plan