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On August 23, 2022, the World Health Organization (WHO) announced that China has passed the assessment of the National Regulatory System (NRA) for vaccines
.
Vaccine NRA assessment is an international assessment that is recognized worldwide and can scientifically and comprehensively evaluate the level of vaccine regulation.
It is an important institutional arrangement for WHO to inspect and evaluate a country's vaccine regulation capability
.
China has passed the assessment twice in 2011 and 2014
.
In 2018, WHO released the latest version of the Global Benchmark Assessment Tool (GBT).
Compared with the previous two assessment tools, the indicators have increased significantly, the content is more comprehensive, and the standards are stricter, covering the entire chain of vaccine supervision and the entire life cycle
.
As the newly added indicators focus on post-market supervision, local regulatory agencies and capacity levels are also fully included in the assessment
.
This NRA assessment involves not only the State Food and Drug Administration, the State Administration for Market Regulation, the National Health Commission, the National Center for Disease Control and Prevention, the General Administration of Customs and other departments, but also local vaccine supervision-related units, requiring cross-departmental, cross-regional and multi-party collaboration
.
The State Food and Drug Administration took the initiative to play a leading role in actively coordinating and communicating, and all parties strengthened cooperation and solidly promoted relevant work to ensure that China passed the evaluation smoothly
.
On August 23, 2022, the World Health Organization (WHO) announced that China has passed the assessment of the National Regulatory System (NRA) for vaccines