日本疫苗全生命周期监管模式的经验与启示

Experience and Enlightenment of Japan's vaccine life-cycle supervision model to China

关键词:  日本  疫苗  全生命周期监管  监管模式

Key words:  Japan  vaccine  full life cycle supervision  regulatory model

摘要:

目的 旨在对日本疫苗全生命周期监管模式进行研究,以期为我国疫苗全生命周期监管体系的完善提供借鉴与参考。方法 采用文献研究法,通过查阅中英文文献、官方政策、报告等对日本疫苗监管体系及全生命周期监管模式进行梳理归纳。结果 研究发现,日本已建立起较为完善的覆盖疫苗研发、生产、流通及上市后全过程的法规制度体系,依靠监管主体责任的落实、冷链运输技术以及信息共享机制和平台等多方面因素形成合理高效的疫苗全生命周期监管模式。结论 建议我国健全疫苗监管法规制度,尤其是紧急使用制度和疫苗接种损害补偿制度；充分发挥各方监管力量并落实相关主体责任；从流程简化、监管队伍专业能力提升及技术引进等方面提升监管效能；完善信息共享平台和机制,以强化我国疫苗全生命周期监管能力。

Abstract:

OBJECTIVE This paper aims to study the whole life cycle supervision model of vaccines in Japan, in order to provide reference for improving the whole life cycle supervision system of vaccines in China. METHODS Using the literature research method, the Japanese vaccine regulatory system and the whole life cycle supervision model were sorted out and summarized by reviewing Chinese and English literature, official policies, reports, etc. RESULTS It is found that Japan has established a relatively complete regulatory system covering the whole process of vaccine research and development, production, circulation and post-marketing, and has formed a reasonable and efficient vaccine life cycle supervision model relying on the implementation of regulatory responsibilities, cold chain transportation technology, and information sharing mechanisms and platforms. CONCLUSION It is suggested that China should improve the system of vaccine regulatory regulations, especially the emergency use system and the vaccination damage compensation system; Give full play to the regulatory power of all parties and implement the responsibilities of relevant entities; Enhance regulatory efficiency in terms of process simplification, professional capacity enhancement of the regulatory team, and technology introduction; Improve the information sharing platform and mechanism to strengthen China's ability to supervise the whole life cycle of vaccines.