摘要
医疗器械监管科学是服务于医疗器械监管的科学研究和活动。循证科学所提倡的"科学和透明原则,开展证据为本"的原则也适用于医疗器械监管科学的相关活动,即采用循证科学的工具和方法,通过证据证明产品全生命周期、使用人群、范围的安全有效和质效与成本-效果。循证科学为医疗器械监管科学提供全新的方法和工具,也为制定科学监管决策提供新依据。
Regulatory science of medical devices serves the scientific research and regulatory activities for supervision of medical devices. Principles of science and transparency and conduction of evidence-based study, which is advocated in Evidence-based science(EBS), also apply to regulatory science of medical devices, including using evidencebased scientific tools and methods to demonstrate the safety and effectiveness, as well as quality, efficacy and costeffectiveness of total life cycle of medical products, target customers, and scope. EBS provides both new methods and tools for regulatory science for medical devices, and provides a new basis for further scientific regulatory decisions.
引文
1中华人民共和国国务院令(第650号).医疗器械监督管理条例.Available at:http://www.nmpa.gov.cn/WS04/CL2076/300561.html.
2国家药品监督管理局(2018年第83号公告).关于发布创新医疗器械特别审查程序的公告. Available at:http://www.nmpa.gov.cn/WS04/CL2093/331560.html.
3U.S. Food and Drug Administration. US-FDA CDRH regulatory science priorities(FY2017). Available at:https://www.fda.gov/MedicalDevices/ScienceandResearch/ucm467550.htm.
4Institute of Medicine. Strengthening a workforce for innovative regulatory science in therapeutic development:Workshop summary. Washington, DC:National Academies Press, 2012.
5U.S. Food and Drug Administration. A frame work for FDA’s regulatory science initiative-advancing regulatory science for public health. Available at:www.fda.gov/download/scienceresearch/specialtopics/regulatoryscience/ucm228444.pdf.
6Moghissi AA, Richard AC, Dennis KM, et al. Innovation in regulatory science:metrics for evaluation of regulatory science claims based on best available regulatory science. J Regul Sci, 2017,7(5):50.
7李幼平,主编.实用循证医学.北京:人民卫生出版社, 2018.
8喻佳洁,李琰,陈雯雯,等.循证医学的产生与发展:社会需求、学科发展和人文反思共同推动.中国循证医学杂志, 2019, 19(1):108-114.
9李琰,喻佳洁,陈雯雯,等.循证医学的科学观和人文观.中国循证医学杂志, 2019, 19(1):114-118.
10 喻佳洁,李琰,陈雯雯,等.从循证医学到循证科学的必然趋势.中国循证医学杂志, 2019, 19(1):119-124.