[关键词]
[摘要]
2008年新药创制重大专项启动实施以来的10多年间,紧密围绕构建国家药物创新技术体系目标,为我国新药研发和公众用药安全提供了重要的保障,获得重大进展。药品监管科学是近十几年发展形成的前沿学科,受到世界科学界和管理界的重视。本文秉着中药监管科学发展与现实存在问题,需要理论创新、药物创新、技术创新、方法创新和应用创新。中药监管科学研究计划是国家推进的9个监管科学行动计划之一。启动以中药临床为导向的中药安全性评价研究,构建中药安全性和质量控制体系。作者认为通过监管科学研究,制定科学规范的中药质量标准和评价指导原则和技术指南,推进中药材、中药饮片和中成药,特别是经典名方制剂品种示范研究,有利于中药产业健康科学发展。在本文中还结合当前的中药监管科学问题,加强药材和饮片的基础研究、中药注射剂质量疗效的再评价研究、经典名方的开发和简化申请的监管科学研究,提出监管科学研究顶层设计建议,制定技术原则与技术指南,有利于药典品种和市场产品的质量和临床有效性再评价。
[Key word]
[Abstract]
In the more than 10 years since the launch of the major new drug innovation project in 2008, the goal of building a national drug innovation technology system has been closely focused, providing important guarantee for the development of new drugs and public drug safety in China and achieving significant progress. Drug regulatory science is a frontier discipline which has been developed in recent ten years. This paper holds that the scientific development and practical problems of Traditional Chinese medicine (TCM) supervision need innovation in theory, medicine, technology, method and application. The TCM regulatory science research program is one of the nine regulatory science plans promoted by the National Medicinal Product Administration. This project starts the safety evaluation research of TCM products based on clinical practice, and constructs the safety and quality control system. The authors believe that it is beneficial to the healthy and scientific development of the TCM industry to establish scientific and standardized quality standards and evaluation guidelines and technical guidelines for TCM, and to promote the demonstration research on TCM, TCM decoction pieces and proprietary Chinese medicines, especially the classic prescription preparations. Authors also combined with the current scientific issues, strengthen the basic research, medicinal material, decoction and injection quality to evaluate the efficacy of research, to develop simplified application science research of classical formulation, and to put forward the top-level design proposal of regulatory science research, formulate technical principles and technical guidelines. These are helpful for the re-evaluation of the quality and clinical effectiveness of pharmacopoeia varieties and market products.
[中图分类号]
[基金项目]