The National Medical Products Administration (NMPA) held a meeting on June 9 to conduct the 2024 annual review of the quality management system (QMS) in vaccine regulation and pharmaceutical manufacturing inspection. NMPA Commissioner Li Li chaired the meeting and fully affirmed the suitability, adequacy, and effectiveness of the NMPA's QMS in these two areas.

　　The establishment and operation of the QMS in vaccine regulation and pharmaceutical manufacturing inspection represents are major effort to meet the assessment requirements of the World Health Organization’s National Regulatory Authority (NRA) for vaccines and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as well as to enhance the national capabilities in vaccine regulation and pharmaceutical manufacturing inspection. The NMPA attaches great significance to the development of the vaccine regulatory QMS, and is dedicated to promoting the regular and standardized operation of the system to continuously enhance the efficiency of vaccine regulatory work by adhering to goal-oriented and problem-focused approaches.

　　At the meeting, the Department of Policies and Regulations and the Department of Drug Regulation respectively reported on the overall situation of the development and operation of the QMS in vaccine regulation and pharmaceutical manufacturing inspection in 2024, highlighted identified problems and follow-up rectifications, and offered suggestions for system improvement. The meeting also reviewed the annual performance of the system in the departments of comprehensive affairs, planning and finance affairs, policies and regulations, drug registration, drug regulation and human resources.

　　Li said that by further enhancing the effective operation of the vaccine regulatory QMS and coordinating the smooth implementation of the QMS in pharmaceutical manufacturing inspection, the NMPA has fully leveraged the QMS’ role in whole-lifecycle monitoring, evaluation and inspection, and continuously improved drug regulation. The NMPA's vaccine QMS and pharmaceutical manufacturing inspection QMS are appropriate, adequate and effective, with remarkable results achieved, he noted.

　　He said that a team of pharmaceutical inspectors have been developed through management on the basis of classification and categories and high-level training to conform to the international standards, while relevant departments have advanced whole-lifecycle quality management, and held regular risk consultations and efficient internal audits to ensure compliant and well-organized drug regulation.

　　He further emphasized the need to enhance nationwide coordination and cooperation in establishing and operating QMS standards. He also stressed the importance of conducting in-depth research and promoting robust drug regulatory capabilities based on sound QMS in line with international standards, so as to contribute to the high-quality development of China's pharmaceutical industry.