Zhejiang Daily:

China has promoted the centralized procurement of drugs, proprietary Chinese medicines, and medical devices. What actions and arrangements have been taken to reinforce quality supervision of the selected products? How is the safety and accessibility of medical devices in the procurement process ensured? Thank you.

Xu Jinghe:

Thank you for your question. The NMPA has attached great importance to supervising the centralized procurement of drugs and medical devices. In strict accordance with the principles of risk management, whole-progress control, scientific supervision, and social governance, we have fully implemented the Four Strictest requirements and ensured that pharmaceutical companies bear the primary responsibility for quality and safety issues. We have also ensured that regulatory departments fulfill their territorial obligations at all levels. Moreover, we have strived to serve the overall situation of national centralized procurement and medical reform work. 

Since the initiation of national centralized procurement, the NMPA has deployed the supervision work for selected drugs and medical devices every year. We have achieved a three-pronged coverage, including supervision and inspection of drug companies and medical device manufacturers, sampling inspections of in-production products, and monitoring of adverse drug reactions (or adverse events related to medical devices). The National Healthcare Security Administration has highly commended this work. Inspections have encompassed nearly 600 pharmaceutical companies and nearly 170 medical device manufacturers. Meanwhile, product sampling has involved 333 medicine varieties and 15 medical device varieties. This has effectively ensured the quality and safety of drugs and medical devices chosen for procurement. At the same time, we have holistically strengthened the implementation of enterprises' primary responsibilities and local regulatory duties. From the perspective of supervision and inspection, sampling inspection, and monitoring of adverse reactions (or adverse events), the quality and safety of the drugs and medical devices selected for procurement has been well-maintained.

In the next step, the NMPA will continue to increase the supervision of selected products in the national centralized procurement, strengthen risk prevention and control, and comprehensively use means such as supervision and inspection, random inspection, and the monitoring of adverse reaction (adverse event) to strengthen early-warning, early investigation and early handling of hidden risks. In terms of drugs, provincial drug supervisory and regulatory authorities will continue to be required to implement enterprise-customized policies and drug-specific files for selected drug manufacturers and holders in centralized procurement, and further strengthen targeted supervision. As for medical equipment, products selected by national centralized procurement, such as intravascular stents, artificial joints and orthopedic spine products, list management is carried out, and medical devices selected by the national centralized procurement are included in the national sampling inspection. We will continue to improve the supervision ability of drugs, develop innovative supervision approaches, strengthen smart supervision and the analysis and sharing of supervision information data for selected drugs and medical devices in centralized procurement, and continue to improve supervision efficiency through information technology to ensure product quality and safety. Thank you.