China's regulatory regime for medical biotechnology: evolution, challenges, and future perspectives

Modern medical biotechnology, while reshaping human healthcare and enhancing social welfare, may also pose biological risks. During the past 40 years, China has made considerable strides in becoming a global leader in biotechnology, necessitating a systematic review of the evolution, current state, and challenges of its regulatory framework. This paper traces the policy trajectory and institutional evolution of China's medical biotech regulation and conducts a policy evaluation within the historical context based on a comprehensive review of laws, regulations, and ministerial rules issued since the 1980s. The biorisk management system is divided into three components and China's policy evolving process into three stages. The analysis is focused on the driving forces of the regulatory policies, the shift of regulatory philosophy, the expansion of regulatory coverage, the current legal and organizational frameworks, and the challenges faced. We find that China's medical biotech regulatory policies have evolved over the past 40 years into a comprehensive regime, spanning the full cycle of research, application and export and covering the dual dimension of security and ethics. It is now supported by multi-tiered laws and regulations, and executed by specialized coordination mechanisms. However, the existing system still falls short in addressing the risks of technological convergence, clarifying the regulatory boundary, strengthening ethical constraints, and enhancing public engagement. Accordingly, we recommend that the agility, clarity, and inclusiveness of China's medical biotech governance should be further improved.