Research on New Architecture for Intelligent
Pharmaceutical Regulation Based on Risk-Native Design

doi:10.1009-0959.2026.060006

Abstract

Abstract:

Objective： To solve the difficulty of effectively implementing risk-based regulation concept under the dilemmas of "post-event response" and "tool lag" faced by traditional intelligent pharmaceutical regulatory architectures， to bridge the architectural divide between advanced concepts and outdated technological tools， and to explore a new pathway for regulatory modernization.Methods： A "regulatory simulation sandbox" validation framework was constructed， a three-tier technical architecture comprising the "data foundation layer， risk intelligence layer， and regulatory application layer" was designed， and key technical issues including AI model governance， interpretability， and continuous monitoring were systematically addressed.Results： The study proposes the “risk-native-design” theoretical paradigm and architecturally elucidates the endogenous implementation mechanisms for risk identification， assessment， early warning， and disposition. Based on a hierarchical analysis of single-link risk-native-design practices， such as the FDA's KASA （knowledge-aided assessment and structured application） initiative， a clear transition pathway from "link-level" risk embedding to "system-level" risk-driven regulation was formulated.Conclusion： The "risk-native-design" paradigm offers a solution that combines theoretical innovation with engineering feasibility for intelligent pharmaceutical regulation. It provides theoretical support and a clear technical pathway for the modernization transformation of pharmaceutical regulation in China.

Key words: Risk-native design； , Risk-based regulation concept； , Risk-driven regulatory operations； , Intelligent regulatory architecture； , Artificial intelligence； , Model governance； , Adaptive regulation； , Regulatory science

CLC Number:

R95
TP311

CHEN Feng, YOU Yuwei.

Research on New Architecture for Intelligent Pharmaceutical Regulation Based on Risk-Native Design [J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2026, 28(6): 647-647-656.

References

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Research on New Architecture for Intelligent Pharmaceutical Regulation Based on Risk-Native Design

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