Health

Supporting the development of innovative drugs and medical devices, stimulating research and development vitality, and caring for people's health

2025-11-24   

Previously, Chinese companies were mainly regarded as cost-effective raw material manufacturers in the global pharmaceutical industry. Now, China has become an important source of global drug innovation. The "15th Five Year Plan" proposes to explicitly support the development of innovative drugs and medical devices. Starting from top-level design to promote innovation in the pharmaceutical industry, this means that China's pharmaceutical industry will usher in a period of growth and vigorous development, with stronger innovation creativity and global competitiveness. In recent years, China has been deeply promoting the reform of the drug evaluation and approval system, continuously releasing policy dividends that encourage innovation, and promoting the sustained vitality of innovative drug and medical device research and development. More "Chinese drugs" suitable for the inheritance of Chinese life genes and physical fitness characteristics have been developed and produced, ultimately benefiting the general public. The National Medical Products Administration actively supports drug innovation guided by clinical value, establishing four accelerated channels for breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval, as well as a 30 day accelerated review and approval channel for innovative drug clinical trials. Relevant policies, regulations, and guiding principles have been formulated and improved, and a full process mechanism for accelerating the launch of innovative drugs from the research and development front end to the review end has been established, accelerating the launch of new and good drugs. In 2024, the average review time for innovative drug market applications in China is 225 working days, among which the average review time for innovative drugs that receive priority review is only 162 working days, significantly improving the speed of review and approval. Since November, the National Medical Products Administration has approved registration applications for three innovative medical devices, including the disposable pressure monitoring cardiac pulse electric field ablation catheter and the thoracoabdominal aortic stent graft system. In 2025, the National Medical Products Administration issued a notice on measures to optimize the full life cycle supervision and support the innovative development of high-end medical devices, proposing support measures from ten aspects, including optimizing special approval procedures, improving classification and naming principles, and continuously improving the standard system, to promote major innovation in high-end medical devices, better meet the health needs of the people, and enhance the international competitiveness of China's high-end medical devices. At present, the technical requirements for drug evaluation in China have been fully aligned with international standards, which means that China's drug regulatory authorities, pharmaceutical companies, and research and development institutions can participate more in the formulation and implementation of international rules and standards. It also means that new drugs developed globally can be simultaneously declared for market in China and overseas according to the same rules. At present, the use of international multicenter clinical data to achieve the "global first launch" of rivastizumab injection and pembrolizumab injection (subcutaneous injection) in China has enabled Chinese patients to enjoy the latest global drug research and development achievements earlier and faster. Since the 14th Five Year Plan, China's pharmaceutical industry has seen an average annual growth rate of 23% in research and development investment, ranking second in the world in terms of the number of new drugs under development. The achievements of independent innovation have accelerated the benefits to more people, including small molecule targeted therapy PD-1、 Significant progress has been made in the "going global" of innovative drugs such as immunotherapy and cell therapy, and the global market's recognition of Chinese innovative drugs is constantly increasing. At the just concluded 8th CIIE, more and more foreign pharmaceutical companies are showcasing their innovative products in China, and are more willing to increase their investment in China and deepen localization cooperation. The Chinese pharmaceutical industry market has grown to become the world's second-largest market, and more and more multinational companies are paying attention to China. At the same time, it should be noted that at present, there are still few original new drugs with new targets and mechanisms of action in China's biopharmaceutical industry, and the ability to innovate at the source is insufficient. Basic research and key core technology research in the field of life sciences still need to be continuously strengthened to provide more "fresh water" for industrial innovation. The relevant person in charge of the National Medical Products Administration stated that enhancing the original innovation capability of biomedicine is a systematic project that requires long-term investment and accumulation in basic research, as well as accelerating the transformation of scientific and technological achievements, fully stimulating the innovation vitality of scientists, and requiring collaborative support and formation of synergy among science and technology, medical care, medical insurance, pharmaceuticals and other departments. The drug regulatory authorities will allocate more resources for review and approval, accelerate the protection of drug trial data, improve the market monopoly period system, further encourage enterprises to increase research and development innovation, fill the gap in domestic therapeutic drugs, and meet urgent clinical needs. (New Society)

Edit:Wang Shu Ying Responsible editor:Li Jie

Source:Xinhuanet

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