The WHO announced in August that the Chinese National Medical Products Administration (NMPA) has achieved maturity level three (ML3) in the WHO’s classification. This means that China has a “stable, well-functioning, and integrated regulatory system to ensure the quality, safety, and effectiveness of vaccines that are manufactured, imported, or distributed in the country”. There are four levels in WHO classification. ML4 is the highest, achieved when the regulatory system is “operating at an advanced level of performance and with continuous improvement”.
In 2014 the WHO assessed the Chinese National Regulatory Authority (NRA), based on the “vaccines assessment tool indicators”. Further benchmarking activities took place in 2019 and 2021. An expert team conducted a “formal benchmarking” in July 2022 using the WHO Global Benchmarking Tool. This tool ensures the “quality, safety, and efficacy of medical products throughout the product life cycle”.
During this recent benchmarking, experts noted that the NMPA had “considered and addressed recommendations made” after prior assessments. Dr Takeshi Kasai, WHO Regional Director for the Western Pacific, congratulated China for this achievement.
“This is a significant step for the global supply of vaccines because of China’s role as a manufacturer, as well as being an important step for public health in China.”
Furthermore, he extended his “appreciation” to the NMPA and associated authorities for their demonstration of a high level of performance. He encouraged NMPA to “scale up the effort towards regulating medicines and other medical products to move up towards the highest level of maturity”.
Dr Mariângela Simão, WHO Assistant Director-General for Access to Medicines and Health Products, believes that this occasion will encourage other countries in the region. She looks forward to more investment in “strengthening regulatory systems”. Additionally, she hopes it will “promote confidence, trust, and further reliance on authorities attaining this level”. Jiao Hong, Commissioner of the NMPA, remarked that this conclusion was “solid proof” that the NMPA is “stable, effective, and well-functioning”.
For a panel discussion on aligning regulatory requirements at the World Vaccine Congress in Europe, get tickets at this link.
