2012年度中国药品审评报告发布 创新药审评时限缩短 Drug approval report of 2012 year China innovation medicine review time shorten

　　国家食品药品监督管理局28日发布《2012年度中国药品审评报告》。报告显示，2012年我国批准的创新药临床试验数量上升，审评时限缩短约2个月。

The state food and drug administration 28[Chinese drug approval report for 2012].According to the report,Approval of innovative drug clinical trials of 2012, China's rise,The review time shorten about 2 months.

　　报告显示，2012年，国家食品药品监管局药品审评中心全年受理新注册申请6919个；完成审批并呈送国家食药监局审批的审评任务4941个，其中建议批准3323个，建议不批准1618个；共批准生产615件药品，其中有3个创新药，分布在抗肿瘤、心血管和血管性疾病领域。

According to the report,In 2012,,State food and drug administration drug review center accepts the new registration throughout the year 6919;Complete feed and presented for examination and approval of national food and drug administration approval to review task 4941,Suggest to approve 3323 of them,Suggest not approved 1618;615 approved production of drugs,There are three innovative drugs,Distribution in anti-tumor/Cardiovascular and vascular disease.

　　药品审评中心主任张培培介绍，2012年，国家食药监局鼓励创新、合理配置审评资源的策略初见成效。获批准的国产创新药临床试验数量由2011年的55件上升到2012年的61件，审评时限从8个月缩短至6个月左右。抗肿瘤药物麦他替尼氨丁三醇片等已经做到与国外同步批准临床，一些具有重要临床价值的进口药品国内外上市时间的差距也有所缩短，如苹果酸舒尼替尼胶囊、克唑替尼胶囊、利匹韦林片、替格瑞洛片等，与美国食品药品管理局批准上市时间间隔近一年。

Director of the center for drug evaluation Zhang Peipei is introduced,In 2012,,National food drug administration encourage innovation/The rational allocation of review resources strategy produced results.Approved domestic innovation medicine clinical trial quantity from 55 in 2011 rose to 2012 in 61,The review deadline from 8 months to 6 months or so.Antitumor drugs for wheat he tromethamine pieces and have done with foreign synchronous clinical approval,Some have important clinical value of the imported drugs gap is to shorten time to market at home and abroad,Such as malic acid ShuNi for capsule/G for azole capsule/The horse waring piece/On behalf of Greg lowe, etc,With the United States food and drug administration approved time interval for almost a year.

　　报告还显示，与既往年度相比，2012年药品审评中心化药受理量略有升高，中药受理量小幅下降，生物制品基本持平。此外，2012年，我国药品注册申请逐渐回归理性，但仿制药重复研发、重复申报现象依然严重，仿制药研发中工业化能力不足问题突出。

The report also shows that,Compared with the previous year,2012 drug approval centralized drug to accept the slightly increases,A slight drop in traditional Chinese medicine (TCM) to accept the amount,Biological products were little changed.In addition,In 2012,,Our country gradually return to rational drug registration application,But generic drugs r&d again/Repeated phenomenon is still serious,Generic drugs research and development of industrial capacity shortage problem is prominent.

　　为提高药品审评效率，鼓励药物创新，国家食品药品监管局日前发布了《关于深化药品审评审批改革进一步鼓励创新的意见》，通过改革药品审评审批工作，进一步加快创新药审评，实行部分仿制药优先审评，以满足国内临床用药的需要。(记者 胡浩)

To improve the efficiency of drug approval,To encourage drug innovation,State food and drug supervision bureau has issued[To further the reform of drug approval review further encourage innovation],Through the reform of drug approval for examination and approval work,To further speed up the innovation medicine review,A part of generics priority review,In order to meet the domestic needs of clinical application.(The reporter Hu Hao)