《生物医学新技术临床研究和临床转化应用管理条例》（以下简称《条例》）将于2026年5月1日起施 行。《条例》的出台背景是什么？适用范围是什么？在支持临床转化应用方面作了哪些规定？日前，司 法部、国家卫生健康委负责人就《条例》的有关问题回答了记者提问。 问：请简要介绍一下《条例》的出台背景。 答：制定《条例》遵循以下总体思路：一是坚持以人民健康为中心，注重防控风险、保障安全。二是支 持生物医学新技术临床研究和临床转化应用，促进创新发展。三是压实机构主体责任，明确临床研究发 起机构、临床研究机构的义务，强化责任落实。 问：《条例》的适用范围是什么？ 答：在我国境内从事生物医学新技术临床研究、临床转化应用及其监督管理，适用《条例》的规定。为 了鼓励创新，为行业发展提供指引，在广泛调研、听取意见的基础上，《条例》将生物医学新技术界定 为运用生物学原理，作用于人体细胞、分子水平的医学新技术，同时规定国务院卫生健康部门会同国务 院药品监督管理部门根据科学技术的发展，制定、调整生物医学新技术与药品、医疗器械的界定指导原 则。 答：开展临床研究对于促进生物医学技术创新、确保技术安全有效具有重要作用。为了更好地支持生物 医学新 ...

Core Points - The newly released regulation aims to standardize clinical research and application of biomedical technologies, promoting innovation while ensuring medical quality and safety [1][2] - The regulation emphasizes the protection of participants' rights, requiring informed consent and prohibiting fees related to clinical research [2][3] - The regulation establishes a clear management framework for clinical research, including approval processes and responsibilities for research institutions [4] Group 1: Regulation Objectives - The regulation is designed to promote the advancement of biomedical science and technology while safeguarding human dignity and health [1] - It addresses the rapid development of biomedical technologies and the need for a robust regulatory framework to manage associated risks [3] Group 2: Clinical Research Management - The regulation specifies conditions and procedures for the clinical application of biomedical technologies, requiring approval from health authorities [2] - It mandates that clinical research must be registered and that institutions must meet specific qualifications to ensure scientific and ethical standards [4] Group 3: Participant Protection - The regulation requires written informed consent from participants or their guardians before conducting clinical research [2] - It stipulates that any health damage caused to participants during research must be promptly addressed by the research institutions [2][4] Group 4: Innovation and Oversight - The regulation aims to create a balance between innovation and safety, establishing a proactive risk management approach [4] - It is expected to enhance transparency and public trust in clinical research through improved oversight and accountability measures [4]

据新华社，国务院总理李强日前签署国务院令，公布《生物医学新技术临床研究和临床转化应用管理条例》（以下简称《条例》），自 2026年5月1日起施行。 《条例》旨在规范生物医学新技术临床研究和临床转化应用，促进医学科学技术进步和创新，保障医疗质量安全，维护人的尊严和健康。 《条例》共7章58条，主要规定了以下内容。 一是明确总体要求。规定开展生物医学新技术临床研究和临床转化应用应当坚持以人民健康为中心，坚持创新引领发展，坚持发展和安全并 重，鼓励和支持临床研究和临床转化应用，加强全过程安全管理。 二是规范临床研究。规定生物医学新技术经非临床研究证明安全、有效，并通过学术审查、伦理审查后，方可开展临床研究。开展临床研究 应当向国务院卫生健康部门备案，国务院卫生健康部门对已备案的临床研究进行评估，发现风险及时纠正直至叫停。加强临床研究实施管 理，采取措施预防控制和处置风险。强化受试者权益保护，强调开展临床研究应当尊重受试者意愿，不得向受试者收取费用，造成受试者健 康损害的应当及时治疗。 三是支持转化应用。规定临床研究证明安全、有效，且符合伦理原则的生物医学新技术，经国务院卫生健康部门批准，可以转化应用于临 床，并明确 ...

来源：新华社 中国政府网 据新华社10月10日消息，国务院总理李强日前签署国务院令，公布《生物医学新技术临床研 究和临床转化应用管理条例》（以下简称《条例》），自2026年5月1日起施行。 李强签署国务院令 公布《生物医学新技术临床研究和临床转化应用管理条例》 中华人民共和国国务院令 第818号 《条例》旨在规范生物医学新技术临床研究和临床转化应用，促进医学科学技术进步和创 新，保障医疗质量安全，维护人的尊严和健康。《条例》共7章58条，主要规定了以下内容。 一是明确总体要求。规定开展生物医学新技术临床研究和临床转化应用应当坚持以人民健康 为中心，坚持创新引领发展，坚持发展和安全并重，鼓励和支持临床研究和临床转化应用， 加强全过程安全管理。 二是规范临床研究。规定生物医学新技术经非临床研究证明安全、有效，并通过学术审查、 伦理审查后，方可开展临床研究。开展临床研究应当向国务院卫生健康部门备案，国务院卫 生健康部门对已备案的临床研究进行评估，发现风险及时纠正直至叫停。加强临床研究实施 管理，采取措施预防控制和处置风险。强化受试者权益保护，强调开展临床研究应当尊重受 试者意愿，不得向受试者收取费用，造成受试者健康 ...

Core Viewpoint - The article discusses the newly published "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies," which aims to standardize clinical research and application of biomedical technologies, promote medical innovation, ensure medical quality and safety, and protect human dignity and health [2][5]. Group 1: Overall Requirements - The regulations emphasize a people-centered approach to health, innovation-driven development, and a balance between development and safety, encouraging clinical research and application while strengthening safety management throughout the process [2][9][10]. Group 2: Clinical Research Regulation - Biomedical new technologies must demonstrate safety and efficacy through non-clinical research and undergo academic and ethical reviews before clinical research can commence. Clinical research must be filed with the National Health Department, which will evaluate and correct risks as necessary [2][18][28]. - The rights of participants must be protected, ensuring that no fees are charged to participants and that any health damages are promptly treated [2][11][35]. Group 3: Support for Translation Applications - Technologies proven safe and effective through clinical research can be applied clinically upon approval from the National Health Department, which will also publish the conditions for medical institutions and professionals involved [3][42][44]. - The National Health Department is required to re-evaluate technologies based on scientific advancements, prohibiting clinical applications if safety and efficacy cannot be assured [3][47]. Group 4: Legal Responsibilities - The regulations impose strict legal responsibilities for violations in clinical research and application, including penalties for unauthorized practices and the requirement to cease operations in case of serious violations [4][53][54].

Core Points - The regulation aims to standardize the clinical research and application of new biomedical technologies, promoting medical science and technology innovation while ensuring safety and ethical standards [2][3] - The regulation defines new biomedical technologies as methods and measures that have not yet been applied clinically in China, aimed at assessing health status or preventing and treating diseases [2][4] - The regulation emphasizes a people-centered approach, encouraging innovation while balancing development and safety [2][4] Chapter Summaries General Principles - The regulation is applicable to all biomedical technology clinical research and applications within the territory of the People's Republic of China [2] - It mandates that all research must have scientific backing, comply with laws and regulations, and prioritize the health and rights of participants [2][4] Clinical Research Filing - Clinical research must be preceded by laboratory and animal studies to ensure safety and efficacy before human trials can commence [4][5] - Institutions initiating clinical research must be legally established entities within China and ensure that the technology has been proven safe and effective through non-clinical studies [5][6] Implementation of Clinical Research - Clinical research must be conducted according to the approved research plan, and any changes must be reported to the health department [11][12] - Institutions must obtain informed consent from participants, ensuring they understand the research's purpose and potential risks [19][21] Clinical Application - After successful clinical research, the application of new biomedical technologies in clinical settings requires approval from the health department [29][30] - The health department will prioritize applications for technologies addressing severe diseases or public health emergencies [32][33] Supervision and Management - Local health departments are responsible for supervising and inspecting clinical research and applications, with the authority to impose penalties for violations [39][40] - An online service system will be established to facilitate the filing and reporting processes for research institutions [42][43] Legal Responsibilities - Violations of the regulation can result in significant fines and penalties, including the suspension of research activities and revocation of licenses for responsible personnel [23][24][25] - Institutions must ensure the accuracy and completeness of all submitted materials and reports [10][11] Miscellaneous - The regulation will come into effect on May 1, 2026, allowing existing research to continue under the new framework [31][32]

Core Points - The State Council of China has issued the "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies," effective from May 1, 2026, aimed at standardizing clinical research and promoting innovation in medical science [1][2] Group 1: Overall Requirements - The regulations emphasize a health-centered approach, innovation-driven development, and a balance between development and safety, encouraging clinical research while enhancing safety management throughout the process [1] Group 2: Clinical Research Regulation - Biomedical new technologies must demonstrate safety and efficacy through non-clinical research and undergo academic and ethical reviews before clinical trials can commence. Clinical research must be filed with the National Health Commission, which will evaluate and address risks [1] - The rights of participants in clinical research are prioritized, prohibiting any fees from being charged to participants and ensuring timely treatment for any health damages incurred [1] Group 3: Support for Translation Applications - Biomedical technologies that are proven safe and effective can be translated into clinical applications upon approval from the National Health Commission, which will also publish the necessary conditions for medical institutions and professionals involved [2] - The regulations include strict legal responsibilities for any violations in the clinical research and application processes [2]

Core Points - The regulation aims to standardize clinical research and application of new biomedical technologies, promoting medical science and ensuring safety and ethical standards [1][2] - The regulation emphasizes the importance of prioritizing public health, innovation, and safety in the development and application of biomedical technologies [1][2] Group 1: General Principles - The regulation defines biomedical new technologies as methods and measures that have not yet been applied clinically in China, aimed at assessing health status or treating diseases [1] - It mandates that all clinical research must be based on scientific evidence and comply with legal and ethical standards [1][2] Group 2: Supervision and Management - The State Council's health department is responsible for overseeing the clinical research and application of biomedical technologies at the national level [2] - Local health departments are tasked with managing and supervising these activities within their jurisdictions [2] Group 3: Clinical Research Registration - Institutions must conduct non-clinical research to prove the safety and efficacy of new technologies before initiating clinical trials [3][4] - Clinical research institutions must meet specific criteria, including being a tertiary hospital and having the necessary ethical and academic committees [4][5] Group 4: Implementation of Clinical Research - Clinical research must be conducted according to approved protocols, and any changes must be reported to the health department [7][8] - Informed consent from participants is mandatory, and institutions cannot charge participants for research-related costs [19][20] Group 5: Clinical Application - After successful clinical research, the application of biomedical technologies requires approval from the health department [29][30] - The health department will prioritize applications for technologies addressing severe diseases or public health emergencies [32] Group 6: Legal Responsibilities - Violations of the regulation can result in significant fines and penalties, including the suspension of clinical research activities [43][44] - Institutions providing false information during the application process may face severe consequences, including the revocation of licenses [51][52]

Group 1: Flood Prevention and Disaster Relief - The meeting emphasized the importance of maintaining vigilance in flood prevention and disaster relief, especially after extreme rainfall events in certain regions [3] - It was noted that while the critical flood prevention period has passed, risks from floods and typhoons still exist, necessitating ongoing efforts in disaster response and recovery [3] - The focus will be on enhancing flood prevention capabilities in northern regions through improved infrastructure and emergency response systems [3] Group 2: Promotion of Private Investment - The meeting highlighted the crucial role of private investment in stabilizing employment and the economy, with a call for practical measures to address key concerns of enterprises [4] - There is a push to expand the scope of private investment, particularly in new productive capacities, emerging service industries, and new infrastructure [4] - The government aims to create a fair competitive market environment by removing barriers to private investment and enhancing support for small and medium-sized enterprises [4] Group 3: Overseas Comprehensive Service System - The meeting discussed the need to strengthen the overseas comprehensive service system to support enterprises in international cooperation and competition [4] - It was proposed to enhance collaboration across legal, financial, and logistical services, and to establish service platforms and overseas service stations in key countries [4] Group 4: Biomedical Technology Development - The meeting underscored the importance of promoting innovation in biomedical technology and accelerating the application of research outcomes to enhance the biopharmaceutical industry [5] - There is a commitment to balancing development and safety by regulating clinical research and ensuring the quality and safety of clinical applications [5]