SCIO briefing on strengthening drug regulation to ensure drug safety for the public
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E-mail China.org.cn, July 28, 2023
Hong Kong Bauhinia Magazine:
Over the past few years, China's medical equipment industry has developed rapidly, with multiple high-level medical devices achieving self-reliance. What measures will be taken to promote the high-quality development of this industry? Thank you.
Jiao Hong:
Thank you for your question. As many of you may have noticed, China's medical equipment industry is currently in a stage of rapid development. Mr. Xu will elaborate on this question.
Xu Jinghe:
Thank you for your question. The CPC Central Committee and the State Council have attached great significance to the innovative development of the medical equipment industry. As General Secretary Xi Jinping has repeatedly emphasized, it's necessary to quickly address weak links in China's high-end medical equipment, make breakthroughs in key and core technologies, and tackle bottlenecks in technology and equipment, to achieve self-reliance and independence in this area. To effectively implement General Secretary Xi Jinping's important instructions, promote the innovative and high-quality development of the domestic medical equipment industry, and better meet people's increasing demand for high-quality healthcare services, the NMPA has mainly concentrated efforts on the following areas of work.
First, we have improved the top-level design and promoted interdepartmental collaboration. The NMPA has jointly issued the "14th Five-Year Plan for National Drug Safety and High-Quality Development" with multiple departments, which clarified the overarching principles, goals, and tasks to promote the high-quality development of the medical equipment industry. We have also jointly issued other documents, including the "14th Five-Year Plan for Medical Equipment Industry Development," with the Ministry of Industry and Information Technology and the National Health Commission to create policy synergy. Furthermore, we have taken the lead in establishing two technological innovation cooperation platforms pertaining to artificial intelligence medical equipment and medical biomaterials, accelerated the transformation and application of scientific and technological achievements in the field of medical equipment, helped to implement an open competition mechanism to select best candidates to undertake key research projects, focused on cutting-edge areas, and made overall plans in advance.
Second, we have further explored how to conduct regulatory work soundly and continually innovated review measures. We launched an action plan to promote regulatory science in medical products administration. Focusing on the frontier areas of technology and regulation, we developed new tools, standards, and methods for medical equipment regulation. We've also established a working mechanism that features early intervention by technical review in the research and development stage. This allows us to provide guidance on advanced medical devices such as ECMO, particle therapy systems, and ventricular assist systems at an earlier stage, accelerating breakthroughs in key and core technologies and driving the overall development of this sector.
Third, we have encouraged innovative medical devices to enter the market and promoted the industry's high-quality development. In recent years, the National Medical Products Administration has focused on innovative medical devices. It has successively issued the Special Review and Approval Procedures for Innovative Medical Products and Priority Approval Procedures for Medical Products so that both innovative products and those meet the urgent needs of clinical treatment can be prioritized and approved efficiently. To date, 217 innovative high-end medical devices, including domestically produced brain pacemakers, carbon ion therapy facility, proton therapy facility, magnetic resonance imaging system, panoramic dynamic PET/CT, third-generation artificial hearts, and artificial blood vessels, have been approved for market launch. This has achieved a breakthrough in the domestic production of high-end medical devices and overcome the challenge where some products were heavily dependent on imports. Most of these products have been used in our current clinical diagnostics and treatment, achieving good results and improving the level of medical diagnosis and treatment.
Next week, we will host the 2023 Medical Device Safety Promotion Week. During that week, we will hold a meeting to discuss the achievements of innovative medical devices. Everyone is welcome to sign up.
With the continuous implementation of various support policies, the medical device industry in China has grown rapidly in recent years, maintaining an average annual compound growth rate of 10.54% over the past five years. It has become the world's second-largest market for medical devices, with increasing industry clustering and international competitiveness. In the next step, the National Medical Products Administration will continue to follow the progress of innovative medical device development, constantly summarizing new experiences, exploring new rules, and introducing new measures. We will approve more and better innovative high-end medical devices for market launch, contributing to the historic leap from a "major medical device producer" to a "strong medical device producer" and enhancing the ability to meet public wellbeing requirements and improve overall satisfaction. Thank you.
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