罕见病药品

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破壁垒 畅循环 激活力——市场监管总局详解“十四五”全国统一大市场建设“成绩单”
Xin Hua She· 2025-08-22 12:42
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]
高质量完成“十四五”规划丨我国医药产业规模位居全球第二位
Xin Hua She· 2025-08-22 08:10
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]
中国医药产业规模居全球第二位
Zhong Guo Xin Wen Wang· 2025-08-22 08:00
Core Insights - China's pharmaceutical industry ranks second globally, with approximately 30% of innovative drugs under research worldwide [1] - During the "14th Five-Year Plan" period, the National Medical Products Administration (NMPA) approved 204 innovative drugs and 265 innovative medical devices, with 50 innovative drugs and 49 innovative medical devices approved in the first seven months of this year [1] - The NMPA has optimized the review and approval process for urgently needed foreign new drugs, accelerating the market entry of pediatric and rare disease medications, approving 387 pediatric drugs and 147 rare disease drugs since the beginning of the "14th Five-Year Plan" [1] Industry Quality and Safety - The NMPA focuses on ensuring drug quality and safety, particularly for vaccines and blood products, implementing regular risk assessment and management in key areas such as rural and urban fringe regions [2] - The agency conducts over 200,000 drug inspections, 20,000 medical device inspections, and 20,000 cosmetic inspections annually, ensuring comprehensive coverage of selected products in national procurement [2] - China supports open cooperation in the pharmaceutical industry, facilitating global clinical trials and shortening the global market entry timeline for drugs, while also encouraging foreign investment in domestic production of original drugs and high-end medical equipment [2]
国家药品抽检合格率稳定在99.4%以上 三大重点举措“护航”用药安全
Yang Shi Wang· 2025-08-22 07:22
Core Insights - The National Medical Products Administration (NMPA) has successfully completed the goals set in the "14th Five-Year Plan" with a drug inspection pass rate stabilizing at over 99.4% [1][5] - The NMPA has implemented three key measures to ensure the safety and effectiveness of medications for the public [1] Group 1: Regulatory Measures - The NMPA conducts over 200,000 drug inspections, 20,000 medical device inspections, and 20,000 cosmetic inspections annually, ensuring 100% coverage of selected products in national procurement [1][3] - The NMPA adheres to internationally recognized standards for the quality and efficacy evaluation of generic drugs [1] Group 2: Support for Pharmaceutical Development - The NMPA has established four expedited approval channels for breakthrough therapies, conditional approvals, priority reviews, and special approvals to support high-quality development in the pharmaceutical industry [3] - Since the beginning of the "14th Five-Year Plan," China has approved 204 innovative drugs and 265 innovative medical devices, with 50 innovative drugs and 49 innovative medical devices approved in the first seven months of this year [5] Group 3: Focus on Traditional Chinese Medicine and Special Populations - The NMPA is promoting the innovation and development of traditional Chinese medicine, having approved 27 innovative traditional Chinese medicines since the start of the "14th Five-Year Plan" [5] - A total of 387 pediatric drugs and 147 rare disease drugs have been approved since the beginning of the "14th Five-Year Plan," addressing the medication needs of key populations [9]
国家药监局:我国医药产业规模位居全球第二位
Zhong Guo Xin Wen Wang· 2025-08-22 03:32
Core Insights - The National Medical Products Administration (NMPA) has approved 204 innovative drugs and 265 innovative medical devices since the beginning of the 14th Five-Year Plan, with 50 innovative drugs and 49 innovative medical devices approved in the first seven months of this year [1][2] - China's pharmaceutical industry ranks second globally, with approximately 30% of innovative drugs under research worldwide [1][2] Group 1: Drug Safety and Regulation - The NMPA emphasizes the importance of drug quality and safety, implementing dynamic supervision throughout the drug lifecycle and establishing a risk consultation mechanism [1] - Special actions have been taken to enhance drug safety, including annual sampling of over 200,000 batches of various drugs and 20,000 batches of medical devices [1] Group 2: Support for Pharmaceutical Development - The NMPA has reformed the review and approval system, introducing four expedited channels for breakthrough therapies and prioritizing certain products for faster approval [2] - The approval of traditional Chinese medicine (TCM) has also increased, with 27 innovative TCM drugs approved during the 14th Five-Year Plan [2] Group 3: Meeting Public Health Needs - The NMPA has optimized the review process for urgently needed foreign drugs, allowing patients to access the latest global drug developments more quickly [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 needs of key populations [2]
北京市“两区”建设五周年成果显著 多区域协同推动高质量发展
Bei Jing Shang Bao· 2025-07-03 12:41
Core Insights - The "Two Zones" initiative in Beijing has achieved significant progress in institutional innovation, industrial development, and optimization of the business environment over the past five years, contributing to high-quality development in the capital [1][6]. Group 1: Institutional Innovation and Business Environment - Haidian District has provided valuable experiences for the national free trade zone through 98 institutional innovation cases, with 4 cases replicated nationwide and 9 cases promoted citywide, establishing a "Haidian Model" [3]. - The implementation of an "all-process online approval" model in Haidian has improved business efficiency by over 30% [3]. - Shunyi District has completed over 200 key tasks related to the "Two Zones" initiative and has formed 16 breakthrough policies and innovative models, achieving an online completion rate of over 95% for district-level approval matters [3][6]. Group 2: Industrial Development - The Yizhuang group has focused on high-end manufacturing and digital economy, achieving breakthroughs in data cross-border, biomedicine, artificial intelligence, and commercial aerospace [4]. - Changping District has developed a globally leading life science valley, with over 10 high-level research institutions and a total of 11 approved innovative drugs, contributing to a comprehensive industrial chain layout [5]. Group 3: Public Services and Talent Development - The Tianzhu Comprehensive Bonded Zone has seen a 95% year-on-year increase in the import of rare disease drugs, with an import value of 21.75 billion yuan, accounting for over 40% of the national total [6]. - Shunyi and Daxing districts are forming a synergistic development force in the biomedical field, enhancing public service systems and creating a talent innovation and entrepreneurship service system [6].
北京海关罕见病药品查验放行时间压缩至“分钟级”
Xin Jing Bao· 2025-06-12 18:40
Group 1 - The core viewpoint of the articles highlights the significant improvements in logistics efficiency and trade facilitation in Beijing due to the "Two Zones" initiative, which has led to faster delivery times for fresh products and increased import values for pharmaceuticals [1][2][3] - Since the implementation of the "Two Zones" initiative, Beijing Customs has introduced over 20 innovative policies, enhancing the approval process for rare disease medications to a "minute-level" inspection and release time, resulting in a substantial increase in the import value of medical materials and drugs from 70 billion yuan in 2020 to 121.2 billion yuan in 2024 [1] - The number of inbound and outbound travelers monitored by Beijing Customs reached 8.99 million in the first five months of this year, a year-on-year increase of 22.8%, indicating a growing potential for inbound tourism consumption [2] Group 2 - The establishment of four comprehensive bonded zones in Beijing over the past five years has significantly boosted trade performance, with the Tianzhu Comprehensive Bonded Zone ranking second nationally in 2023 and achieving an import and export value exceeding 100 billion yuan [2] - The implementation of an integrated regulatory model at the Daxing Airport Comprehensive Bonded Zone has reduced transportation time for goods from one hour to ten minutes, enhancing operational efficiency [2] - Since the RCEP agreement came into effect in 2022, Beijing's trade with RCEP countries has surpassed 2 trillion yuan, reflecting closer regional economic cooperation and improved benefits for local foreign trade enterprises [3]