To analyze the priority challenges in vaccine regulation in China and provide reference for the improvement of the national regulatory system.
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.
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.
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.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |