Meeting held to step up preparations for NRA assessment

The National Medical Products Administration (NMPA) held a meeting on March 14 in preparation for the National Regulatory Authority (NRA) assessment of vaccines by the World Health Organization (WHO). NMPA Deputy Commissioner Zhao Junning attended the meeting and delivered a speech.

It was noted at the meeting that the Communist Party of China Central Committee and the State Council have always attached great importance to vaccine safety. The NRA assessment of vaccines is a comprehensive evaluation of the national vaccine regulatory capacity and level. It is a task that concerns national honor, the Chinese drug regulator's image and public health. It serves as a foundation for Chinese vaccine products to be used abroad and is also a work priority for the NMPA.

In 2021, all preparations for the assessment were carried out in an all-around way and achieved good results. All related departments and provincial-level administrations, under the leadership of the NMPA, have steadily pushed forward relevant preparations and successfully completed the WHO's remote mid-term assessment.

The meeting also called for more endeavors to continuously improve the vaccine regulatory quality management system and ensure the consistency of the vaccine regulatory systems. It also put emphasis on cross-departmental and cross-regional cooperation and information disclosure to ensure coordination of relevant sub-indicators of each sector.

In terms of current problems and challenges, it is important to carefully analyze causes and accelerate rectification and improvement. Efforts should be made not only to pass the assessment, but also to lay a solid foundation for the modernization of China's vaccine regulatory system and capacity in the long run.

Zhao said all preparations for the WHO's official assessment in June 2022 have entered the final sprint. All of the departments and provincial-level administrations should promote relevant work with a high sense of responsibility to comprehensively demonstrate China's vaccine regulatory capacity and level.

It is necessary to ensure collaboration between all departments and efficiently keep work on schedule and pay close attention to indicator requirements and opinions of WHO experts to fill in gaps. Provincial-level administrations responsible for on-site assessments should carry out drills in advance and concentrate on details. A complete national regulatory system, unified quality management standards and rigorous and orderly operation status should be prepared before the assessment. At the same time, the NMPA and all provincial-level administrations should continue to strengthen supervision and inspection of vaccines, enhance construction of inspector teams and continuously elevate vaccine regulatory capacity and level, he said.

The meeting was held both online and offline. Members of the NMPA NRA assessment leadership group and working group, officials of the National Health Commission and the Chinese Center for Disease Control and Prevention participated in the meeting on site. Officials of provincial-level administrations and members of working groups in Beijing, Tianjin, Liaoning, Jilin, Shanghai, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Sichuan and Yunnan attended the meeting online.