[关键词]
[摘要]
监管科学是近年发展形成的前沿学科,受到世界科学界和管理界的重视。在医药产品开发和评价中,所用的科学技术必须进行改进,目前主要从8 个主要领域来发展监管科学:(1)毒理学的现代化;(2)推动临床评价和个体化医疗的创新;(3)创造新的方法以改进产品的生产工艺并提高产品质量;(4)确保食品药品监管机构已经为创新技术的评估做好充分准备;(5)借助信息科学利用好各种数据;(6)推行以预防为主的食品安全体系;(7)加快制定医疗对策以抵御各种威胁;(8)进一步发展社会和行为科学以帮助消费者在选择产品时做出知情决策。从转化研究角度,从监管科学到科学监管的发展,监管科学面临的挑战和机遇、监管科学与科学监管的关系等方面进行简要论述,并对我国监管科学的发展提出建议。
[Key word]
[Abstract]
Regulatory science is a cutting-edge science in recent years. The science and management communities attach importance to its development. The modern science and technology used in the development and evaluation of medicinal products conducted a thorough reform, with the current mainly from eight major areas to develop regulatory science: (1) modernize toxicology to enhance product safety, (2) stimulate innovation in clinical evaluation and personalized medicine to improve product development and patient outcomes, (3) support new approaches to improve product manufacturing and quality, (4) ensure food drug administration readiness to evaluate innovative emerging technologies, (5) harness diverse data through information sciences to improve health outcomes, (6) implement a new prevention-focused food safety system to protect public health, (7) facilitate development of medical countermeasures to protect against threats to global health and security, and (8) strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products. In this review on translational research, from a regulatory science to scientific regulation, authors discussed the development of science and regulation, regulatory challenges and opportunities facing the scientific, regulatory relationship between science and the scientific supervision of other aspects briefly discussed, and some suggestions for the development of regulatory science in China.
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[基金项目]