WANG Jin-zi, TANG Han, XU Xian-xing, ZHANG Ti-deng, HUANG Zhe, YE Jia-hui
As critical biological products related to public health security, vaccines require specialized quality regulation with strategic significance. Against the backdrop of the implementation of the Vaccine Administration Law of the People's Republic of China, this study focuses on China's resident vaccine inspector system. Through in-depth interviews with 19 stakeholders from regulatory agencies and vaccine enterprises, combined with policy text analysis, the research systematically examines the operational mechanisms and implementation outcomes of the system. It was revealed that the resident inspector system, underpinned by a preventive regulatory model of “on-site facility supervision, risk early warning, and rectification closed-loop”, demonstrates significant efficacy in controlling quality risks at the source and enhancing corporate compliance. However, there exist structural challenges, including discontinuities in talent echelons, fragmented training systems, insufficient incentive mechanisms, lagging digital capabilities, and immature coordination mechanisms between dispatched inspections and daily supervision. To address these issues, the study proposes a five-in-one optimization framework integrating “professional talent selection, systematic training, quantitative evaluation, technological empowerment, and mechanism linkage”. Specific recommendations include establishing cross-regional talent-sharing mechanisms to alleviate workforce shortages, adopting a combined training model of “theoretical learning, practical drills, and simulated inspections” to enhance competency, develop a KPI assessment system based on risk detection metrics and corporate satisfaction, strengthen digital system operation training and information and intelligent terminal equipment, enhance the coordinated development of dispatched inspection and daily supervision. The research provides theoretical support for improving the vaccine lifecycle regulatory system, offers practical insights for enhancing regulatory precision and mitigating systemic quality risks.
