我国2007年版《药品注册管理办法》实施对创新药品研发的激励作用评析

Simulation Effect of the Implementation of Drug Registration Regulation(2007 Edition) on Innovatory Drug Research and Development in China

目的:为完善我国药品注册监管制度提供参考。方法:选取创新药品研发的投入、产出能力2个一级指标,企业创新资金投入强度、企业研发人员投入强度、新药注册受理情况、新化学实体药物获批情况4个二级指标,构建相关评价指标体系,通过整理2000、2005、2011等年度的《中国高技术产业统计年鉴》、国家食品药品监督管理局药品审评中心《受理品种目录》提供的数据,对比我国2007年版《药品注册管理办法》实施前、后创新药品研发投入(1995-2010年)与产出(2003-2010年)2个方面的情况就其激励作用进行评价和分析,并提出建议。结果:1995-2004年创新药品研发资金投入强度由0.97%提升至2.02%,2008年小幅回落至1.82%,此后2年一直稳定在1.8%左右;1995-2004年我国医药制造业科技人员中科学家和工程师比例由2.17%稳步增长至4.07%,2008年已提升至6.02%,此后2年维持在约5%;2007年我国药品注册受理数量由2003-2006年的万余件大幅下降至7371件,2010年达史上最低,仅为6636件;2004年新化学实体药物获批准2例,2007、2009、2010年均为0例,2008年1例。结论:2007年版《药品注册管理办法》的实施对创新药品研发产出有一定的激励作用,但仍需要从药品上市审批监管制度的实体和程序2个方面进行完善。

OBJECTIVE：To provide reference for improving the drug registration regulatory system in China.METHODS：The input and output capacity of innovatory drug research and development（RD） were adopted as first level index,and innovatory fund input density,RD staff input density,new drug registration and acceptance,approved new chemical drug were used as second level index to establish related evaluation index system.By arranging data from China High Technology Industry Statistics Yearbook of 2000,2005 and 2011 year and List of Accepted Type by center for drug evaluation,SFDA,the investment（1995-2010） and the output（2003-2010） of innovatory drug RD were compared before and after the implementation of Drug Registration Regulation（2007 edition）,the simulation effect was evaluated and analyzed to put forward suggestions.RESULTS：The innovatory fund input density increased from 0.97% to 2.02% during 1995-2004,backing down a bit to 1.82% in 2008,kept at about 1.8% in the following 2 years.The proportion of scientists and engineers in technical staff of pharmaceutical manufacturing increased from 2.17% to 4.07% during 1995-2004,increasing to 6.02% in 2008,kept at about 5% in the following 2 years.The number of drug registration and acceptance decreased from more than ten thousand during 2003-2006 to 7 371 in 2007,and the lowest of 6 636 in 2010.2 cases of new drugs got approval in 2004,none of cases in 2007,2009 and 2010 and only 1 case in 2008.CONCLUSION：Drug Registration Regulation（2007 Edition） has promoted innovative drugs RD,but still need to be improved and perfected from both the entity and the procedures of drug listing approval and supervision system.