The World Health Organization (WHO) announced that China has successfully passed the evaluation of its vaccine National Regulatory Authority (NMPA), following the WHO’s upgrade of evaluation standards in July 2023. This marks the third time China’s vaccine regulatory system has met WHO criteria, following previous assessments in 2011 and 2014.
Significance of NRA Evaluation
Passing the NRA evaluation is a prerequisite for WHO procurement of a country’s vaccines and serves as a reference for regulatory filings in other countries. It also enables Chinese manufacturers to apply for WHO pre-qualification, allowing their products to be included in the procurement lists of the United Nations and other international organizations.
China’s Vaccine Achievements
Since first passing NRA evaluation, China has seen multiple domestically developed vaccines, including the live attenuated Japanese encephalitis vaccine, type I type III live attenuated polio vaccine, and inactivated hepatitis A vaccine, achieve WHO pre-qualification. These vaccines have been procured by UNICEF, GAVI, and other international agencies and exported to dozens of countries. Additionally, three COVID-19 vaccines have obtained WHO Emergency Use Authorizations (EUAs) since the pandemic’s onset.-Fineline Info & Tech
