Requirements of Vaccine Vigilance Function from NRA Assessment

doi:10.19803/j.1672-8629.2021.04.06

Abstract

Abstract: The national regulatory system (NRA) plays an important role in ensuring the quality,safety and effectiveness of vaccines.At the same time, vaccine manufacturers in a country have to pass the NRA evaluation by the World Health Organization (WHO) to obtain the prequalification(PQ) of vaccines. China will undergo a new round of NRA evaluation in 2021. In this paper, the NRA evaluation was introduced. Combined with the status quo of vaccine vigilance in China, the indicators of vigilance function of NRA evaluation were analyzed.On this basis, ways to promote vaccine vigilance in China were recommended.

Key words: vaccine, WHO, NRA, vigilance, AEFI

CLC Number:

R994.11

YU Yi, WANG Yali. Requirements of Vaccine Vigilance Function from NRA Assessment[J]. Chinese Journal of Pharmacovigilance, 2021, 18(4): 324-327.

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