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This paper aims to analyze the evolution and challenges of China's medical biotechnology regulatory framework over the past 40 years.

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

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Systematic review evaluates the evolution of biotech regulations in China, suggesting improvements for future governance.

This paper aims to analyze the evolution and challenges of China's medical biotechnology regulatory framework over the past 40 years.
Conducted a systematic review of laws, regulations, and ministerial rules since the 1980s.
Divided biorisk management into three components and regulatory evolution into three stages.
Evaluated driving forces behind regulatory policies and identified key challenges.
China's regulatory policies have developed into a comprehensive framework addressing research, application, and export.
The system covers both security and ethics through multi-tiered laws and specialized coordination mechanisms.
Challenges include addressing risks from technological convergence and enhancing public engagement.

Enkai Zhang (2026) studied this question.

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