Reform Of Government Supervision Mode Of Human Vaccine In China

Since the establishment of national Drug Administration(NDA)as an independent department,China’s vaccine regulatory work has undergone many reforms,with considerable development and related problems.In 2020,with the sudden outbreak of COVID-19 spreading all over the world,China has made remarkable achievements in the fight against the epidemic.With the continuous development of new technologies,vaccine regulation has become the key to the development of China’s public health undertakings.Facing the new situation of infectious disease outbreak,the reform of vaccine supervision in China is imminent.In recent years,the systematic,scientific and emergency management of vaccine regulation needs to be further improved.In order to explore the way out of vaccine regulation reform,this paper reviewed the development process of vaccine regulation in China based on the situation of vaccine regulation at home and abroad,divided vaccine regulation into two parts:vaccine approval and vaccine supervision,analyzed the reasons behind the problems,and found out the way out of vaccine regulation in the future.It is found that China has actively learned the advanced experience and cases of European and American countries in the history of vaccine regulation,and has made some achievements in the reform of the review and approval system.It has actively explored the priority review and approval and the system of drug marketing authorization holders,and has carried out the most stringent supervision over the vaccine industry.However,there are shortcomings in the top-level design of supervision and the construction of supervision capacity.Therefore,in order to further improve the level of vaccine supervision in China,countermeasures and suggestions are put forward from the following five aspects:establishing and improving a systematic and sustainable vaccine supervision system;The implementation of three-party coordination of three-dimensional supervision mechanism;Administration and supervision in accordance with the law to promote fair supervision;Strengthening capacity building of vaccine supervision in the whole process;Encourage technological innovation and regulatory innovation to match.