NMPA holds meeting on vaccine regulatory QMS
To advance the development of China's National Regulatory Authority (NRA) for vaccines and further enhance the country's vaccine regulatory capacity, the National Medical Products Administration (NMPA) held a working meeting on the development of the vaccine regulatory quality management system (QMS) in Changzhou, Jiangsu province, on June 12.
During the meeting, participants conducted an on-site survey of the implementation of the QMS at the Changzhou Inspection Branch and the Changzhou Subcenter for Evaluation and Inspection of Jiangsu Provincial Medical Products Administration.
Participants were also briefed on the progress of preparations and arrangement for the World Health Organization's Vaccine Listed Authority (WLA) assessment. The Department of Policies and Regulations of the NMPA presented detailed requirements for establishing and operating the vaccine QMS. Representatives from the regulatory authorities of Beijing, Jiangsu and Guangzhou shared their experiences in QMS development. Discussions were held on ensuring coordination between the QMS frameworks of the NMPA and provincial-level authorities.
The meeting was attended by officials from the NMPA's Department of Policies and Regulations, Department of Drug Registration, and Department of Drug Regulation, as well as representatives from the China Health-Media Group and provincial-level regulatory authorities responsible for vaccine production.
