另外，对于临床急需境外已上市境内未上市的罕见病药品，鼓励申请人采取前置检验方式申请注册检 验。只进行样品检验的，注册检验时限由60日缩短至40日；同时进行标准复核和样品检验的，注册检验 时限由90日缩短至70日。 "对于临床急需境外已上市境内未上市的罕见病药品，注册检验所需样品量为商业规模生产1批次。"国 家药监局在发布的公告中明确表示。 这一新政将过去需多批次、大样本量的检验要求大幅简化。曾经因检验要求过高而难以进入中国市场的 罕见病药品，现在找到了可行的路径。 上海市卫生和健康发展研究中心主任金春林对21世纪经济报道记者表示，该新政的出台对医药产业影响 深远。临床急需的药品（特别是治疗罕见病的药品）将更快进入中国市场，不仅能解决患者无药可用的 困境，加速药品可及性，还能降低用药成本。通过引入境外仿制药申报机制，有望在原研药之外提供更 具经济性的治疗选择，进一步减轻患者负担。 "对制药企业而言，新政明确了研发与申报的目录导向，鼓励企业在中国开展全球同步研发与申报。这 将推动跨国企业更早将中国纳入全球研发计划，助力优化资源配置。通过接受境外临床数据、优化核查 流程等方式，可以帮助企业节省在中国重复开展临床试验 ...

（来源：中国妇女报） 2025年，我国药品、医疗器械领域临床急需产品上市实现跨越式增长。国家药监局全年批准药品上市注 册申请4087件，其中创新药76个，创历史新高。境内外上市时间差进一步缩短，59件境外新药获临时进 口批准。儿童用药优先审评审批机制持续推进，全年批准儿童药138个。罕见病药品临时进口通道持续 畅通，全年批准罕见病药品48个，有效填补特殊群体用药空白。 医药产业国际化步伐提速，创新药对海外授权交易额累计突破1300亿美元，标志着我国迈向"创新药输 出大国"。 李利表示，2026年国家药监局将精准施策，重点推进多项工作。药品领域将推动药品试验数据保护制度 落地，研究建立儿童药品、罕见病用药市场独占期制度；对新机制、新靶点创新药，在沟通交流、临床 试验、注册申报、审评审批全链条强化服务支持，助力创新药"中国首发"选取部分地区开展新申报仿制 药前置服务试点提升申报质量。 转自：中国妇女报 据新华社北京1月7日电（记者 戴小河） 我国将对新机制、新靶点的创新药，在沟通交流、临床试验、 注册申报、审评审批全链条强化服务支持，助力创新药"中国首发"。 这是国家药监局局长李利在1月6日召开的全国药品监督管理 ...

新华社北京1月7日电（记者戴小河）我国将对新机制、新靶点的创新药，在沟通交流、临床试验、 注册申报、审评审批全链条强化服务支持，助力创新药"中国首发"。 这是国家药监局局长李利在1月6日召开的全国药品监督管理工作会议上介绍的工作部署。 2025年，我国药品、医疗器械领域临床急需产品上市实现跨越式增长。国家药监局全年批准药品上 市注册申请4087件，其中创新药76个，创历史新高。境内外上市时间差进一步缩短，59件境外新药获临 时进口批准。儿童用药优先审评审批机制持续推进，全年批准儿童药138个。罕见病药品临时进口通道 持续畅通，全年批准罕见病药品48个，有效填补特殊群体用药空白。 回望整个"十四五"期间，我国医药创新的累积效应充分释放。5年间共230个创新药获批，实现大幅 增长；中药领域研发势头强劲，28个中药创新药获批；医疗器械创新生态持续完善，292个创新产品相 继获批，覆盖诊疗、康复、监护等领域。 李利表示，2026年国家药监局将精准施策，重点推进多项工作。药品领域将推动药品试验数据保护 制度落地，研究建立儿童药品、罕见病用药市场独占期制度；对新机制、新靶点创新药，在沟通交流、 临床试验、注册申报、审评审 ...

Core Viewpoint - The article emphasizes the importance of strict and efficient regulation in promoting 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 NMPA has implemented comprehensive reforms in drug regulation, ensuring overall stability in drug safety and advancing the construction of a strong pharmaceutical nation [2]. - Continuous strengthening of supervision has led to a significant increase in the overall pass rate of drug safety inspections from 97.8% during the 13th Five-Year Plan to 99.4% [2]. - A total of 220 innovative drugs and 282 innovative medical devices have been approved, marking increases of 6.2 times and 3.1 times, respectively, compared to the previous five-year period [3]. Group 2: Future Measures for Drug Safety Regulation - The NMPA plans to enhance the drug safety responsibility system and transition from a "passive defense" to a "proactive prevention" approach [5]. - A focus on dynamic safety regulation across the entire supply chain will be implemented, addressing new challenges posed by product and technological innovations [6]. - Strict enforcement against illegal activities will be prioritized, with improved mechanisms for cross-regional and cross-level case handling [6]. Group 3: Support for Innovative Drug and Medical Device Development - The NMPA will support enterprises in enhancing their research and development capabilities for innovative drugs and medical devices, emphasizing the importance of effective market and proactive government roles [7]. - Policies will be optimized to accelerate the approval process for innovative products, particularly those that are globally novel or critical for domestic substitution [8]. - The NMPA aims to improve the regulatory framework for traditional Chinese medicine, ensuring quality management and modernization of production processes [8]. Group 4: Enhancing Public Benefit from Regulatory Reforms - The NMPA will prioritize enhancing public access to innovative treatments and ensuring that regulatory reforms benefit the general population [9]. - Efforts will be made to streamline the approval process for urgently needed drugs, including those for rare diseases and pediatric use [9]. - Collaboration with health and insurance departments will be strengthened to ensure comprehensive drug safety and accessibility [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] 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]