To further advance the regulatory Quality Management System (QMS) and promote its sustainable and standardized operation, the National Medical Products Administration (NMPA) held a specific training session in Beijing on Oct 31 for QMS internal auditors engaged in vaccine regulation and pharmaceutical production inspection. The training was designed to align with the assessment requirements of the National Regulatory Authority (NRA) for vaccines of the World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

QMS experts were invited to give lectures, providing a detailed overview of the origin and evolution of the ISO 9000 family of standards and an explanation of the requirements of the GB/T 19001-2016 criteria in the contexts of the WHO benchmarking tool and the current development of the NMPA's QMS.

Officials of related NMPA departments and affiliated institutions outlined the development of the NMPA's QMS in vaccine regulation and pharmaceutical production inspection, and shared best practices in QMS development and operation from across the national pharmaceutical regulatory system, promoting a deeper integration of QMS development with regulatory work. More than 50 officials from NMPA departments took part in the training.

Since 2020, the NMPA has been conducting annual internal audit, which plays a role in ensuring compliance with QMS requirements and enhancing regulatory capacity.