The National Medical Products Administration (NMPA) conducted its 2025 annual management review of the Quality Management System (QMS) for regulation of vaccine and drug Good Manufacturing Practice (GMP) compliance on June 30. NMPA Commissioner Huang Guo presided over the meeting and fully affirmed the suitability, adequacy and effectiveness of the NMPA's QMS in both areas.

The establishment and operation of the QMS for regulation of vaccine and drug GMP compliance is critical to enhance China's capabilities in these fields and to meet the requirements of the World Health Organization's National Regulatory Authority (WLA) for vaccines and the Pharmaceutical Inspection Co-operation Scheme (PIC/s). The NMPA attaches great importance to the QMS development, adheres to both goal-oriented and problem-oriented approaches and continuously strengthens the regularized and standardized operations of the system to improve regulatory efficiency and effectiveness.

At the review meeting, the Department of Policies and Regulations and the Department of Drug Regulation respectively reported on the overall development and operation of the NMPA's QMS for regulation of vaccine and drug GMP compliance in 2025, highlighting identified problems, corrective actions taken and suggestions for system improvement. The meeting also reviewed the annual performance of the QMS across the Department of Comprehensive Affairs, Planning, and Finance Affairs, Department of Policies and Regulations, Department of Drug Registration, Department of Drug Regulation and Department of Human Resources.

Huang noted that through the development of the QMS, the NMPA has continuously improved its regulatory work, optimized resource allocation and promoted personnel training, thereby providing strong support for enhancing the quality and effectiveness of regulation of vaccine and drug GMP compliance. He said that all relevant departments have rigorously implemented risk management requirements, carried out comprehensive risk identification and prevention and steadily optimized whole-process management. Following three consecutive years of sustained efforts, provincial-level drug regulatory authorities across the country have completed their observation of the NMPA's internal review, he added, calling for further efforts to promote the comprehensive and multi-level coordination, alignment and improvement of the system based on the current progress.

He also emphasized the need to conduct in-depth research on the integration of the QMS with regulatory work and make practical efforts to deepen and consolidate the development of the QMS, so as to enhance the effectiveness of vaccine and drug regulation and provide strong support for the modernization of China's system and capacity for governance.