欧洲促进新抗菌药物研发的措施及经验  

Improvement Measures and Experiences of New Antibiotics R&D in Europe

作　　者：冯晶晶[1] 王小万[1] 崔月颖[1] 

机构地区：[1]北京协和医学院/中国医学科学院医学信息研究所,北京100020

出　　处：《中国药房》2014年第1期7-9,共3页China Pharmacy

摘　　要：目的:为完善和发展我国新抗菌药物研发的激励措施提供借鉴。方法:分析阻碍新抗菌药物研发的主要因素,总结欧洲促进新抗菌药物研发的措施和经验。结果与结论:欧洲阻碍新抗菌药物研发的主要因素有使用受到管制、净现值较低、监管环境较严格、面临巨大技术挑战。欧洲促进新抗菌药物研发的措施主要有通过早期研发资助以降低研发者进入门槛的促进性措施,奖励技术进步的完成即在研发成功后提供奖励的引导性措施,将前二者内外结合、相互推动并相互促进的综合性措施;综合性措施比促进性措施和引导性措施更有效。相关经验包括建立产品开发合作伙伴关系、加快监管部门的审批、将部分抗菌药物归为稀缺药品(孤儿药)等,在不同程度上促进了新抗菌药物的研发。OBJECTIVE： To provide references for the improvement of incentives for new antibiotics Research ＆ Development （R＆D） in China. METHODS： The main factors of limiting new antibiotics R＆D were analyzed, and European incentives and ex- perience of new antibiotics R＆D were summarized. RESULTS ＆ CONCLUSIONS： Main factors of limiting new antibiotics R＆D in Europe are limited use of antibiotics, low net present value, strict monitoring environment and big technical challenge. Main in- centives for new antibiotics R＆D in Europe include early R＆D support which lowers the barriers to be researcher; the complement of technical progress encouragement means that encouragement should be supplied for the success of new antibiotics R＆D; above two measures are combined inside and outside and improve each other. Comprehensive mechanism is more effective than incentive measures and introductory measures. The establishment of product development partnerships, the acceleration of regulatory approval and orphan drug designation can stimulate new antibiotics R＆D in varying degrees.

关 键 词：抗菌药物 研发 创新 措施 经验 

分 类 号：R95[医药卫生—药学]