Abstract: Fragmentation, diffusion, concealment and diversification compose of modern drug safety risk features. From the perspective of risk governance theory, there exist some defects within drug regulatory system, including single institutional function, decentralized administration, individual risk ignorance and "campaign-style" emergency management. To improve the performance of drug regulation and reconstruct the top design of drug regulatory system, it is necessary to take advantage of this round of administrative reform and the "Drug Administration Law" revision. Policy suggestions of a new paradigm of drug safety risk governance system are followed: innovate drug safety risk analysis framework, establish a high-level drug administration coordinating body, improve local regulatory system, and mobilize the involvement of stakeholders.