Core Viewpoint - The newly announced regulation by the Chinese State Council on the management of clinical research and application of biomedical new technologies establishes a systematic framework for the clinical research and transformation of these technologies, effective from May 1, 2026. This regulation primarily targets new medical technologies that utilize biological principles and act at the cellular or molecular level, which have not yet been applied clinically in China [2][13]. Summary by Sections 1. Regulation Scope and Definition - The regulation defines "biomedical new technologies" as medical methods and measures that utilize biological principles to assess health status, prevent or treat diseases, and promote health, specifically targeting those not yet applied clinically in China [13][14]. - It consolidates various innovative methods from fields like stem cells, gene therapy, and regenerative medicine under a unified regulatory framework, indicating that all new medical technologies affecting the basic units of life will be subject to national regulation [14]. 2. Affected Entities and Roles - The regulation outlines the roles of various entities involved in the research and application of biomedical technologies, including regulatory bodies, research initiators, clinical research institutions, project leaders, and professional evaluation agencies [15][16][18][19]. - The National Health Commission (NHC) will oversee the management and ensure compliance with the regulation, while local health departments will handle supervision and enforcement [15][16]. 3. Research to Application Process - A complete closed-loop system is established from research filing to clinical transformation, requiring approval from the NHC before any new technology can be applied clinically [21][22]. - The NHC will publish the names of approved technologies, the medical institutions allowed to use them, and the conditions and operational standards for their application [22]. 4. Historical Context and Policy Evolution - The regulation is not a standalone initiative but builds upon previous trial management methods and local explorations, marking a transition from pilot policies to comprehensive legislation [23][27]. - It enhances the legal standing of biomedical technology management from departmental regulations to administrative laws, expanding the scope from stem cell therapy to all biomedical technologies affecting cellular and molecular levels [23][28]. 5. Compliance and Legal Responsibilities - The regulation introduces stringent compliance requirements, including high penalties for violations, emphasizing the need for ethical governance and the protection of participants in clinical research [30][31][46]. - It establishes a comprehensive lifecycle governance framework for biomedical technologies, from non-clinical research to ethical review, national filing, process reporting, and post-application evaluation [47]. 6. Implications for Stakeholders - Hospitals must meet stricter entry requirements, including having academic and ethical review committees, and must maintain comprehensive records for 30 years [48]. - Pharmaceutical companies need to navigate dual regulatory pathways for clinical trials and medical technology research, ensuring compliance with both drug administration and new technology regulations [50]. - Medical device companies, especially those involved in bio-device intersections, must enhance collaboration with hospitals and ensure compliance with both medical device regulations and the new biomedical technology framework [56]. - Academic institutions are encouraged to prepare for compliance by establishing clear pathways for technology transfer and collaboration with clinical institutions [57]. 7. Key Timelines and Action Items - The regulation will take effect on May 1, 2026, and existing projects must comply with the new filing requirements within one month of the regulation's implementation [62]. - Stakeholders are advised to prepare comprehensive compliance assets that encompass the entire research and application process to maintain competitiveness under the new regulatory environment [63].