刍议创新药物研发的生态环境与创新药物研发  

Relationship of Ecosystems and Resolution of New Drug Research and Development

作　　者：陶秀梅[1] 董江萍[2] 黄蕾 江德元[1] 

机构地区：[1]国家食品药品监督管理总局高级研修学院,北京100073 [2]国家食品药品监督管理总局药品注册司,北京100053 [3]北京诺康达医药科技有限公司,北京100176

出　　处：《中国药学杂志》2016年第7期592-597,共6页Chinese Pharmaceutical Journal

摘　　要：目的通过对比美国和中国创新药物临床需求、行业发展政策、企业自身因素、上市申请审评、审批机制,上市药品数量和特点差异,尤其对me-only、me-better、me-too的上市情况进行分析说明中美创新药研发生态环境的差异,进而对中国创新药物的研发提出相应的观点。方法运用文献研究和对比分析的方法比较对美国和中国创新药物(狭义创新药物)研发产生影响的重要因素,进而阐明我国当前创新药研发和管理的策略。结果从2000年至2015年随着美国创新药物研发生态环境的改变,尤其是FDA审评、审批制度-PDUFA I到PDUFA V推进,FDA审评、审批的效率逐渐提高,美国创新药物的临床可及性得到很大程度的满足,90%以上在规定时限内审批完成,完成新分子实体上市的数量达到413个,CFDA在近15年内,创新药物的上市数量为33个。结论药品的可获得性是国家安全的重要内容,药物创新能力市场可及性是一个国家创新能力的重要标志,药品创新是一项系统工程,其生态环境也相对复杂,美国在该领域处于世界领先地位,其中相关的因素和方式对当代中国的创新药物产业发展具有借鉴意义。OBJECTIVE Relationship of ecosystems and resolution of new drug research and development is analyzed through a comparison of the clinical needs,industry development policy,enterprise-self factor,listing application mechanism,number and characteristics of new drug in America and China,especially,the market conditions of the me-only,me-better and me-too between America and China is analyzed importantly. The idea that the new drug is studied and developed in China is presented. METHODS The important influencing factors that affected the ecosystems of new drug research and development were analyzed by comparison methods and data studies. RESULTS The clinical availability of new drug in America is significant increased recently and over 90% applied new drugs can be finished in a limited time based on the evolution of the innovative ecological environment of new drug research and development from 1993 to 2014,new drugs are approval listing in America and China respectively. CONCLUSION The availability of new drug is very important to a state security. The ecosystem of new drug research and development is very complicated. The relative field in America is more advanced than in China and it is used for reference to the new drug research and development in China.

关 键 词：创新药物 影响因素 发展策略 

分 类 号：R951[医药卫生—药学]