Huang Guo, Deputy Director of the National Medical Products Administration: China is the world’s largest and most active pharmaceutical market

　　China News Service, March 25. The 2024 Annual Meeting of the China Development Forum will be held on March 24-25, 2024. On the afternoon of March 24, the "Big Health Industry Symposium" was held. Huang Guo, deputy director of the State Food and Drug Administration, said in the "Keynote Speech One" session: China is the world's largest and most active pharmaceutical market and the most important. A major pharmaceutical manufacturing country with the most stable total volume and predictable growth.

　　Huang Guo summarized and introduced the important measures taken by the State Food and Drug Administration in recent years to promote the deepening reform of my country's pharmaceutical industry and achieve high-quality development from four aspects.

First, continue to deepen reform and innovation to speed up drug review and approval beyond China's speed.

Unswervingly and continuously deepen the reform of the drug review and approval system, improve the quality and efficiency of government services, and effectively promote the innovative development of the industry with strict, efficient and fair regulatory measures. For example, we will increase guidance and support for the research and development of innovative pharmaceutical devices, establish four channels to speed up marketing registration through the "Measures for the Administration of Drug Registration", and implement a new model of early intervention, one enterprise, one policy, full guidance, and strict review linkage for key varieties, which will greatly Greatly shorten the review and approval cycle.

Second, continue to improve the system of regulations and standards to provide Chinese wisdom for the legalization of drug supervision.

Based on the "Drug Administration Law" and "Vaccine Administration Law", we will gradually improve the legal system with laws, regulations, departmental regulations, normative documents, and technical guiding principles as important components, and strive to create a fair and just legal environment.

Third, deeply participate in international cooperation and contribute China’s strength to the international governance of drug safety.

Adhering to the concepts of openness, inclusiveness, cooperation and win-win, we will continue to deepen international cooperation and exchanges. For example, it will deepen cooperation with the World Health Organization, give full play to the role of a member of the International Technical Coordination Committee for the Registration of Pharmaceuticals for Human Use (ICH), and actively promote joining the International Pharmaceutical Inspection Cooperation Scheme (PIC/S).

Fourth, strengthen the construction of the regulatory system and explore Chinese solutions for long-term stability in drug safety.

Actively serve regional major strategies, set up the Yangtze River Delta sub-center and the Greater Bay Area sub-center for technical review and inspection of drugs and medical devices, optimize prior and in-process communication guidance and related inspection and review work, support innovative research and development of pharmaceutical companies, and provide close support to high-end local pharmaceutical industry Quality development; set up a special drug inspection center in Hebei to comprehensively strengthen the quality supervision of special drugs; continue to strengthen the construction of regulatory talent teams and accelerate the enrichment of the national drug review team; launch the China Drug Supervision Scientific Action Plan; promote smart supervision and further deploy and promote Informatization leads the modernization of drug supervision, etc.

　　Huang Guo said that

China's development requires an open world, and the development of the world cannot be separated from China's strength. A series of measures for drug regulatory reform demonstrate China’s confidence and determination to continue to promote reform, opening up, and innovative development. Facing the new situation and new challenges brought about by the current rapid development of the pharmaceutical industry, the State Food and Drug Administration will strive to create a better business environment for enterprises and provide more convenient services for pharmaceutical enterprises to invest in business and innovate research and development.