美国FDA对医疗组合产品的监管  

U.S. FDA’s Regulation for Medical Combination Products

作　　者：牟岚 杜新 MU Lan;DU Xin(Bio-Thera Solutions,Ltd,Guangzhou 510530,China;Adlai Nortye Biopharma Co.,Ltd.,Hangzhou 310018,China)

机构地区：[1]百奥泰生物制药股份有限公司,广东广州510530 [2]杭州阿诺生物医药科技股份有限公司,浙江杭州310018

出　　处：《药学进展》2019年第12期892-899,共8页Progress in Pharmaceutical Sciences

摘　　要：医疗组合产品是将至少2种不同类型的医疗产品(如药品、生物制品或医疗器械)组合在一起联合使用的"第四类型"产品。该类产品采用新颖尖端的技术,协同不同组成部分的作用,相对于单一产品更加安全有效,其优势在肿瘤、心脏病、神经疾病和代谢疾病等方面已得到充分证明。随着人工智能、纳米技术、健康信息技术、分子诊断技术以及细胞和组织工程学等新技术的迅速成长,越来越多的医疗组合产品被开发并推向市场,造福患者。美国FDA逐步建立起一套关于医疗组合产品的监管方法。介绍和分析FDA对医疗组合产品的监管,旨在为中国医药企业研发医疗组合产品提供启示和参考。Medical combination products(MCPs) are the "fourth type" of medical products combining at least two different types: drugs, medical devices and/or biological products to produce therapeutic or diagnostic results better than those independently utilized. This type of product uses new and cutting-edge technology to work with different drug components, which is safer and more effective than single component. Their advantages have been well demonstrated in cancer, heart disease, neurological and metabolic diseases. With the advance of new technologies, such as artificial intelligence, nanotechnology, health information technology, molecular diagnostics, and cell and tissue engineering, more and more combination products have been marketed and have greatly benefited the patients. The U.S. FDA has gradually established a regulatory approach to medical combination products. Analyzing and understanding FDA’s regulation for medical combination products will benefit China’s pharmaceutical companies venturing into the development of medical combination products.

关 键 词：医疗组合产品 监管策略 产品研发 

分 类 号：R951[医药卫生—药学]