Experience and Enlightenment of Japan's Vaccine Life-cycle Regulation Model

OBJECTIVE  To study the whole life cycle regulation model of vaccine in Japan, and to explore its reference for optimizing the whole life cycle regulation system of vaccine in China.

METHODS  Using the literature research method, the Japanese vaccine regulatory system and the whole life cycle regulation model were sorted out and summarized by reviewing Chinese and English literature, official policies, reports, etc.

RESULTS  Japan had established a regulatory system that covered the whole process of vaccine research and development, production, circulation and post-marketing; and had formed a relatively reasonable and efficient vaccine life cycle regulation model by implementating regulatory responsibilities, applying cold chain transportation technology, and building information sharing mechanisms and platforms.

CONCLUSION  China can learn from Japan's experience and improve the regulatory system for vaccine, 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 regulate the whole life cycle of vaccine.