Core Insights - The event "2025 Shenzhen International High-Performance Medical Device and Innovative Pharmaceutical Exhibition Hong Kong Station" focuses on the theme "Innovative Drugs and Devices, Collaborative Win-Win" and aims to deepen cross-border cooperation in the pharmaceutical and medical device sectors between Shenzhen and Hong Kong [1] Group 1: Event Overview - The event is guided by multiple health and regulatory bodies from Shenzhen and Hong Kong, featuring a "conference + exhibition" model to explore cutting-edge technology trends and collaborative development measures [1] - Over 300 representatives from more than 120 enterprises, universities, and research institutions participated, showcasing significant medical devices and innovative pharmaceutical products [4] Group 2: Expert Contributions - Notable experts shared insights on various topics, including the application prospects of infrared fluorescence imaging in precision medicine and global trends in digital healthcare [2] - The discussions highlighted the importance of industry-academia-research collaboration for innovation [2] Group 3: Collaborative Achievements - A series of landmark collaborative achievements were announced, including the launch of the GCOG precision treatment clinical trial and the establishment of a collaborative platform for international clinical trials in the Greater Bay Area [3] - Several partnerships were formed in key areas such as cell gene therapy and drug development, aiming to create a "research-application" integration platform and an international service network [3] Group 4: Innovation Showcase - The event featured high-performance medical devices such as surgical robots and automated immunoassay analyzers, demonstrating the industrial strength and innovative vitality of the Shenzhen-Hong Kong region [4] Group 5: Future Development - The forum focused on themes like cell and gene therapy and opportunities in innovative drug and device development, providing intellectual support for industry growth [5] - The event serves as a model for soft connectivity in the Greater Bay Area's pharmaceutical and medical device industry, promoting a new model of industrial linkage between Shenzhen and Hong Kong [5]

新华社北京12月10日电 题：以高效严格监管促进创新药和医疗器械发展——访国家药品监督管理局党 组书记、局长李利 新华社记者赵文君、戴小河 药品是治病救人的特殊商品，保障药品安全有效是严肃的政治问题、基本的民生问题、重大的经济问 题、严谨的技术问题。党的二十届四中全会审议通过的《中共中央关于制定国民经济和社会发展第十五 个五年规划的建议》（以下简称《建议》）对加强药品安全工作，支持创新药和医疗器械发展等提出明 确要求。 "十四五"以来，我国药品监管事业取得了哪些成效？"十五五"时期，如何切实维护药品安全？如何鼓励 支持医药企业研发创新，推动实现药品高水平安全和医药产业高质量发展良性互动？新华社记者采访了 国家药品监督管理局党组书记、局长李利。 推动制药强国建设迈出坚实步伐 问："十四五"以来，我国药品监管事业取得哪些成效？ 答："十四五"以来，全国药品监管系统坚持以习近平总书记提出的"四个最严"要求为根本遵循，全过程 深化药品监管改革，全方位筑牢药品安全底线，全链条支持产业高质量发展，有效保障药品安全形势总 体稳定，推动制药强国建设迈出坚实步伐。 ——持续强化监管，保障药品质量安全。相继开展了药品安全专项整治 ...

Core Viewpoint - The article emphasizes the importance of strict and efficient regulation to promote the development of innovative drugs and medical devices in China, highlighting the achievements and future plans of the National Medical Products Administration (NMPA) in ensuring drug safety and supporting industry innovation [1] Group 1: Achievements During the 14th Five-Year Plan - The drug regulatory system in China has adhered to the "four strictest" requirements, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2] - Continuous strengthening of regulation has ensured drug quality and safety, with over 200,000 batches of drugs and 20,000 batches of medical devices tested annually, resulting in an overall drug sampling pass rate increase from 97.8% to 99.4% [2] Group 2: Industry Innovation and Development - A series of measures have been implemented to deepen the reform of drug and medical device regulation, resulting in the approval of 220 innovative drugs and 282 innovative medical devices, which are 6.2 times and 3.1 times higher than during the 13th Five-Year Plan, respectively [3] - The approval of 415 children's drugs and 155 rare disease drugs has further enhanced the vitality of innovation in the pharmaceutical industry [3] Group 3: Regulatory Capacity Enhancement - The establishment of a relatively complete legal system for drug regulation has been achieved, with the issuance of the 2025 edition of the Pharmacopoeia of the People's Republic of China and numerous standards for traditional Chinese medicine and medical devices [4] - Significant progress has been made in the informatization of drug regulation, with the establishment of key laboratories and the implementation of 59 major projects in regulatory science [4] Group 4: Future Measures for Drug Safety - The NMPA plans to enhance drug safety management by shifting from "passive defense" to "active prevention," improving the risk prevention and control capabilities [5] - A dynamic safety supervision mechanism covering the entire lifecycle of drugs will be established, focusing on clinical trials, commissioned production, and online sales [6] Group 5: Support for Innovative Drug and Medical Device Development - The NMPA will support enterprises in strengthening the research and development of innovative drugs and medical devices, emphasizing policy guidance and resource allocation for original products and domestic alternatives [7] - Efforts will be made to accelerate the listing of innovative drugs and medical devices by optimizing registration processes and enhancing intellectual property protection [8] Group 6: Ensuring Public Benefit from Regulatory Reforms - The NMPA aims to ensure that regulatory reforms benefit the public by enhancing access to essential drugs and maintaining high standards for generic drugs [9] - Collaboration with health and insurance departments will be strengthened to improve drug traceability and ensure the safety and effectiveness of medications [10]

Core Viewpoint - The article emphasizes the importance of strict and efficient regulation to promote the development of innovative drugs and medical devices in China, highlighting the achievements and future plans of the National Medical Products Administration (NMPA) in ensuring drug safety and supporting industry innovation [1][2]. Regulatory Achievements During the 14th Five-Year Plan - The NMPA has implemented comprehensive reforms in drug regulation, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2]. - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2]. Industry Innovation and Development - A total of 220 innovative drugs and 282 innovative medical devices were approved during the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3]. - The NMPA has also approved 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines [3]. Strengthening Regulatory Capacity - The NMPA has revised key regulatory laws and established a more comprehensive legal framework for drug regulation, enhancing the consistency of Chinese standards with international standards [4]. - The establishment of new inspection centers and regional review centers has improved the regulatory capacity of the NMPA [4]. Transition to Proactive Drug Safety Management - The NMPA aims to shift drug safety management from a "passive defense" approach to a "proactive prevention" model, enhancing risk identification and responsibility accountability [5]. - A dynamic safety supervision mechanism covering the entire lifecycle of drugs is being developed to address new challenges in product and technology innovation [6]. Support for Innovative Drug and Medical Device Development - The NMPA plans to enhance support for the research and development of innovative drugs and medical devices, focusing on policy guidance and resource allocation for original products [7]. - Efforts will be made to streamline the approval process for innovative products and improve the protection of intellectual property rights related to drug research [8]. Ensuring Public Benefit from Regulatory Reforms - The NMPA is committed to ensuring that regulatory reforms benefit the public, focusing on enhancing people's sense of gain, happiness, and safety [9]. - The agency will expedite the approval of urgently needed drugs and maintain high standards for generic drug quality to ensure affordable access to effective medications [9]. Collaborative Governance in Healthcare - Strengthening collaboration with health and insurance departments is essential for improving clinical trial oversight and drug traceability [10]. - The NMPA will enhance public awareness of drug safety and regulatory policies through education and outreach initiatives [10].

Core Viewpoint - The National Medical Products Administration (NMPA) emphasizes the importance of combining effective market mechanisms with proactive government support to enhance innovation in pharmaceuticals and medical devices, aiming to transform new medical technologies into productive forces [1][8]. Group 1: Achievements in Drug Regulation - Since the 14th Five-Year Plan, the drug regulation system has adhered to the "four strictest" requirements, leading to comprehensive reforms and a stable drug safety situation, thereby advancing the construction of a strong pharmaceutical nation [3]. - The NMPA has conducted over 200,000 drug inspections and 20,000 medical device inspections annually, improving the overall drug inspection pass rate from 97.8% during the 13th Five-Year Plan to 99.4% [3][4]. Group 2: Support for Innovation - The NMPA has approved 220 innovative drugs and 282 innovative medical devices since the 14th Five-Year Plan, which is 6.2 times and 3.1 times the number approved during the 13th Five-Year Plan, respectively [4]. - The NMPA aims to enhance the innovation capacity of the pharmaceutical industry by optimizing regulatory policies, focusing on original products and domestic alternatives to critical technologies [8][9]. Group 3: Future Measures for Drug Safety - The NMPA plans to shift drug safety management from a "passive defense" approach to "active prevention," enhancing risk management and collaboration across departments [6][7]. - The agency will implement a comprehensive drug safety responsibility system and improve the regulatory framework to ensure high-quality development in the pharmaceutical sector [6][10]. Group 4: Enhancing Public Welfare - The NMPA is committed to ensuring that regulatory reforms benefit the public, focusing on enhancing people's sense of gain, happiness, and safety [10][11]. - Efforts will be made to expedite the approval of urgently needed drugs, including those for rare diseases and pediatric use, while maintaining high standards and procedures [11][12].

Core Viewpoint - The article emphasizes the importance of drug safety and regulatory reforms in China, highlighting achievements during the 14th Five-Year Plan and outlining strategies for the 15th Five-Year Plan to enhance drug safety and support innovation in the pharmaceutical industry [1][2]. Achievements During the 14th Five-Year Plan - The national drug regulatory system has adhered to the "four strictest" requirements, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2]. - Continuous strengthening of regulation has ensured drug quality and safety, with over 200,000 batches of drugs and 20,000 batches of medical devices tested annually, resulting in an overall drug inspection pass rate increase from 97.8% to 99.4% [2][3]. Innovation and Development Support - A series of measures have been implemented to promote innovation in the pharmaceutical and medical device sectors, with 220 innovative drugs and 282 innovative medical devices approved, marking increases of 6.2 times and 3.1 times, respectively, compared to the previous five-year period [3][4]. - The approval of 415 children's drugs and 155 rare disease drugs has further enhanced the vitality of innovation in the pharmaceutical industry [3]. Regulatory Capacity Enhancement - Revisions to key regulatory laws and the establishment of a comprehensive legal framework for drug regulation have been prioritized, alongside significant advancements in drug regulatory information technology [4]. - The establishment of specialized inspection centers and regional review centers has strengthened the capacity for drug regulation [4]. Transition to Proactive Drug Safety Management - The regulatory approach is shifting from "passive defense" to "active prevention," focusing on risk identification and responsibility enforcement to maintain drug safety [5][6]. - A dynamic safety supervision mechanism covering the entire lifecycle of drugs is being developed to address new challenges in product and technology innovation [5]. Support for Innovative Drug and Medical Device Development - The regulatory body aims to enhance the clinical value and technological content of innovative drugs and medical devices, supporting enterprises in their research and development efforts [7]. - Policies will be optimized to facilitate faster market entry for innovative products, including the implementation of a national drug standard improvement plan [8]. Ensuring Public Benefit from Regulatory Reforms - The regulatory work will prioritize enhancing public satisfaction and safety, ensuring that the benefits of reforms reach all citizens [9]. - Efforts will be made to expedite the approval of urgently needed drugs and improve the quality and efficacy of generic drugs [9]. Strengthening Social Cooperation and Public Awareness - Increased efforts in policy interpretation and public education on drug safety and regulatory measures are planned to enhance societal understanding and support for innovation in the pharmaceutical sector [10].