Advancing Regulatory Science. -Moving Regulatory Science into the 21st Century. /ScienceResearch/SpecialTopics/RegulatoryScience/default.htm?utm_campaign=Goo
美国FDA监管科学的措施（3）
FDA-CDRH确定监管科学十大优先领域
FDA-CRDH 2018年监管科学10大优先领域
依托大数据监管决策 革新生物相容性评价 真实世界数据 临床评价的预测和监控 临床试验设计 计算建模 数字化健康和网络安全 健康相关的感染 患者输入 精准医疗和生物标志物
FDA发布器械开发工具 Medical Device Development Tools (MDDT)
The FDA's Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
◦ a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment
◦ 非临床评价odel
◦ a nonclinical test method or model (e.g. in vitro "bench," animal or computational model) that measures or predicts device function or performance in a living organism.
欧美医疗器械监管科学现状
医疗器械监管科学 Regulatory Science
质量 安全 有效 性能
监管科学
新工具 新标准 新途径
欧盟EMA definition:
◦ Range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied medicinal science and social sciences, and contributes to the development of regulatory standards and tools.
美国FDA definition:
◦ Science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.
European Medicines Agency process for engaging in external regulatory sciences and process improvement research activities for public and animal health EMA/14946/2013. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/03/WC500139888.pdf
美国FDA-CDRH
构建监管科学的正反馈模型 positive feedback model of regulatory science
美国FDA监管科学的措施（3）
FDA发布CDRH Regulatory Science Priorities
CDRH's regulatory science priorities serve as a catalyst to improve the safety, effectiveness, performance, and quality of medical devices
美国FDA监管科学的措施（1）
专门 机构
推进监管科学倡议
美国FDA监管科学的措施（2）
FDA与大学共建监管科学与创新中心
Centers of Excellence in Regulatory Science and Innovation (CERSIs): University of Maryland （马里兰大学） UCSF-Stanford （加州大学旧金山分校-斯坦福） Johns Hopkins University （约翰霍普金斯大学） Yale-Mayo Clinic（耶鲁-梅奥医学中心） 目标：Research, Scientific Exchanges, and Training CERSI Steering Committee Charter, Research Priority Areas and Metrics
The FDA has defined three categories of MDDT
◦ 临床效果评价 Clinical outcome assessment
◦ measures of how a patient feels or functions
◦ 生物标记物测试 Biomarker test