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 regulation in promoting the development of innovative drugs and medical devices, highlighting the balance between ensuring drug safety and fostering industry innovation [1] Group 1: Achievements in Drug Regulation - Since the 14th Five-Year Plan, China's 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] - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2] Group 2: Promoting Industry Innovation - A total of 220 innovative drugs and 282 innovative medical devices were approved since the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3] - The approval of 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines, indicates a growing vitality in pharmaceutical innovation [3] Group 3: Future Measures for Drug Safety - The regulatory focus will shift from "passive defense" to "active prevention," enhancing the drug safety responsibility system and improving risk management capabilities [4] - A comprehensive dynamic safety supervision system will be established, covering the entire lifecycle of drugs, from research and development to production and use [5] Group 4: Supporting Innovation in Pharmaceuticals - The regulatory body will support enterprises in enhancing their innovative drug and medical device research and development, emphasizing policy guidance and resource allocation for original products [6] - Efforts will be made to accelerate the market entry of innovative drugs and medical devices by optimizing registration processes and reducing costs [7] Group 5: Enhancing Public Welfare - The regulatory work will prioritize enhancing public satisfaction and safety, ensuring that regulatory reforms benefit all citizens and meet their health needs [8] - Measures will be taken to expedite the approval of urgently needed drugs, including those for rare diseases and children, while maintaining high standards [9] Group 6: Interdepartmental Collaboration - Strengthening coordination with health and insurance departments will be crucial for improving clinical trial oversight and drug traceability systems [10] - Public awareness campaigns will be conducted to enhance understanding of drug regulations and promote a supportive environment for innovative drug and device development [11]

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].

Core Viewpoint - The head of the National Medical Products Administration, Li Li, emphasizes the need to strengthen public awareness and accelerate the fulfillment of clinical medication demands [1] Group 1: Regulatory Approaches - The administration plans to fully utilize breakthrough therapy drugs, conditional approvals, priority reviews, and special approvals to expedite the review and approval of urgently needed overseas new drugs, rare disease medications, and pediatric drugs [1] - There is a commitment to maintain high standards and procedures while steadily expanding the scope of consistency evaluations for the quality and efficacy of generic drugs [1] Group 2: Patient-Centric Initiatives - The administration aims to shorten the distance from laboratory innovations to patient care, ensuring that innovative results benefit the public more quickly [1] - Efforts are being made to promote age-friendly and barrier-free reforms in drug labeling, encouraging the provision of accessible versions of drug instructions [1]

Core Insights - The development of pediatric drugs has become a focal point in the market due to current policies promoting priority reviews and approvals [1] - There is a significant unmet demand for pediatric medications, with only a small percentage of drugs specifically designed for children [2] - The National Medical Products Administration (NMPA) has issued guidelines to encourage the development of modified new drugs for children, emphasizing the importance of protecting the rights of child participants in clinical trials [3][4] Industry Overview - Over 90% of pediatric medications in China are not specifically designed for children, highlighting a critical gap in the pediatric drug supply system [2] - The market for pediatric drugs is expanding, but issues such as drug shortages and lack of evidence-based clinical use remain prevalent [2] Regulatory Developments - The NMPA's recent response outlines the need to encourage the development of modified new drugs for pediatric use, which can include expanding existing adult drugs to children [3] - The guidelines stress that clinical value for pediatric drugs may differ from adult applications, allowing for a broader interpretation of clinical benefits [4] Clinical Trial Considerations - The NMPA emphasizes the importance of minimizing unnecessary repetitive studies in pediatric drug development, advocating for the use of existing research evidence [6] - Ethical considerations are paramount in pediatric clinical trials, with a focus on ensuring the safety of child participants [6][7] Research Methodologies - Real-world studies (RWS) are highlighted as a valuable complement to randomized controlled trials (RCT) in pediatric drug development, especially when ethical challenges arise [8] - The use of adult data extrapolation is acknowledged, but caution is advised as safety data may not fully predict adverse reactions in children [7]

Group 1 - The core achievement of the "14th Five-Year Plan" is the high-quality development of market regulation, which has created a more vibrant and fair market environment, supporting the construction of a unified national market and promoting high-quality economic and social development [1] Group 2 - Since the beginning of the "14th Five-Year Plan," there has been a net increase of 19.99 million enterprises and 33.946 million individual businesses in China, indicating a significant activation of enterprise vitality [2] - The market access has become more standardized, with reforms in the registration capital system and the implementation of a unified negative list for market access, enhancing the credibility of registered capital [2] - The process for business exit has been streamlined, allowing businesses to exit the market in as little as 21 days through simplified procedures [2] - The efficiency of business operations has improved, with the time to open a restaurant reduced from 37 days to 15 days and the number of required documents for business information changes reduced from 23 to 6 [2] Group 3 - The regulatory enforcement effectiveness has been enhanced, with a total of 89.028 million complaints processed during the "14th Five-Year Plan," recovering economic losses of 21.71 billion yuan for consumers [3] - The pharmaceutical industry has seen significant growth, ranking second globally, with approximately 30% of innovative drugs under research [3] - A total of 387 children's drugs and 147 rare disease drugs have been approved for market entry, addressing the needs of key populations [3] Group 4 - The legal foundation for building a unified national market has been strengthened, with significant amendments to the Anti-Monopoly Law and the third revision of the Anti-Unfair Competition Law [4] - Efforts to eliminate local protectionism and maintain a unified market have led to the discovery and elimination of 4,218 policies that hinder resource flow, as well as the investigation of 239 cases of administrative monopoly [4] Group 5 - The market regulation authority is focusing on the healthy development of the platform economy, emphasizing the need for a balanced approach to regulation and promotion [5] - Continuous special actions are being taken to regulate the online market, particularly addressing issues in live e-commerce and ensuring fair competition among online platforms [5] - The goal is to further advance the construction of a unified national market, breaking down local protectionism and market segmentation to create a fair competition environment for all business entities [5]

Core Insights - The pharmaceutical industry in China ranks second globally, with approximately 30% of innovative drugs under research worldwide [1][2] - The National Medical Products Administration (NMPA) is focused on ensuring drug safety, supporting high-quality development of the pharmaceutical industry, and meeting public medication needs [1][2] Group 1: Drug Safety Measures - China is enhancing dynamic regulation covering the entire lifecycle of drugs, establishing a risk consultation mechanism, and focusing on key areas such as online sales, contract manufacturing, and clinical trial management [1] - The country plans to conduct over 200,000 drug inspections, 20,000 medical device inspections, and 20,000 cosmetic inspections annually during the 14th Five-Year Plan [1] Group 2: Support for Pharmaceutical Development - Since the beginning of the 14th Five-Year Plan, 204 innovative drugs and 265 innovative medical devices have been approved, with 50 innovative drugs and 49 medical devices approved in the first seven months of this year [2] - The NMPA is implementing expedited review channels for breakthrough therapies and prioritizing the approval of key products through tailored guidance [1][2] Group 3: Meeting Public Medication Needs - The approval process for urgently needed foreign drugs has been optimized to allow faster access to the latest global drug developments for Chinese patients [2] - A total of 387 pediatric drugs and 147 rare disease drugs have been approved since the start of the 14th Five-Year Plan, addressing the medication needs of key populations [2]