Analyzing priority challenges in China's vaccine regulation with the Hanlon method

WANG Ri-zhen; XU Ming; PAN Hai-long; ZUO Shu-yan; YUAN Yuan; HUANG Yang-mu

doi:10.20251/j.cnki.1003-3734.2026.07.001

Abstract：Objective:To analyze the priority challenges in vaccine regulation in China and provide reference for the improvement of the national regulatory system.Methods:A list of possible challenges in vaccine regulation in China was generated through literature review and in-depth interviews.Using the Hanlon method,expert consultation was conducted to assess the importance,severity and feasibility of intervention for these potential challenges to screen out priority challenges.Results:The expert response rate was 83.5%,the expert authority coefficient was 0.772,and the coordination coefficients for expert scoring on the importance,severity,and feasibility of intervention of potential challenges were 0.576,0.517,and 0.510,respectively(P<0.05).According to the results of the Hanlon's analysis,the top five priority challenges in vaccine regulation in China were:inadequate development of regulatory human resources;an underdeveloped information disclosure and public communication mechanism;an incomplete quality management system within regulatory authorities;weak quality management capabilities in some enterprises;and insufficient coordination in accelerated regulatory processes.Conclusion:This study suggests that strengthening the development of professional human resources,improving mechanisms for information disclosure and public communication,enhancing quality management system construction,guiding enterprises to implement self-regulation,and coordinating accelerated regulatory mechanisms are five key dimensions for systematically advancing vaccine regulatory capacity and comprehensively improving the level of vaccine regulatory governance in China.