Abstract: Biosafety is an important part of national security. To cope with the biosafety crisis， all countries have successively formulated a series of regulatory laws， but the actual results have not been significant. One important reason is that it relies too much on the “command-control” regulatory path， and ignores the complexity of the highly differentiated society and the unique operating laws of other social subsystems. In practice， the biosafety regulatory path has plunged into such difficulties as insufficient constraints， decentralized and flooded legislation， and loose supervision， etc. In this regard， the theory of reflexive law in sociology of law recognizes the limitation of legal cognition capacity， emphasizes the self-regulation of various social subsystems， and provides a new way to break the bottleneck of China's biosafety regulation. Based on paradigm innovation under the framework of reflexive law combined with its organizational， procedural and negotiation regulatory strategies， a semi-autonomous social system for biosafety is formed to overcome the disadvantages of the traditional regulatory model.

Key words: biosafety regulation; social system theory; reflexive law