对我国药品上市后再评价工作的文献分析  

Literature Analysis of Post-marking Drug Reevaluation in China

作　　者：班雅倩 常新义 袁晓龙[1] 孙建勋[1] 

机构地区：[1]河南大学药学院,河南开封475004

出　　处：《中国药房》2014年第9期859-862,共4页China Pharmacy

摘　　要：目的:了解我国药品上市后再评价的研究状况,为药品再评价工作开展提供参考。方法:采用文献研究、类比等方法,以"药品上市后安全性再评价""药品再评价"等为关键词,对中国期刊全文数据库和万方数据库中1999年1月-2013年4月的有关药品上市后再评价的文献进行统计分析,概述我国药品上市后再评价研究现状并与国外相关工作进行比较,分析我国药品上市后再评价工作的不足之处。结果与结论:与美国、英国、日本等比较,我国药品上市后再评价相关工作起步较晚,虽已有部分法规但仍存在相关法律法规不健全、研究方法缺乏权威性和规范性、再评价责任主体不清等问题。亟需制订统一规范的药品上市后再评价管理办法等,明确药品企业在药品上市后再评价中的责任主体地位,正确区分药品不良反应监测、药品上市后研究与药品上市后再评价的关系。OBJECTIVE： To investigate the status quo of post-marking drug reevaluation in China, and to provide reference for carrying out drug reevaluation. METHODS： By the methods of literature study and analogy, the literatures about post-marking drug reevaluation during Jan. 1999--Apr. 2013 from CNKI and Wanfang database were analyzed statistically, using keywords as ＂post- marking drug safety reevaluation＂＂drug reevaluation＂, etc. The status quo of post-marking drug reevaluation in China was reviewed and compared with foreign ones. The deficiency of post-marking drug reevaluation in China was analyzed. RESULTS ＆ CONCLU- SIONS： Compared with United States, Britain, Japan, etc., the work of post-marking drug reevaluation have developed late in China; there are some problems, such as relevant laws and regulations are not sound; authoritative and normative research methods are absent; the subject of responsibility is not clear. It is urgent to formulate uniform reevaluation method of post-marking drugs, confirm the dominant place of pharmaceutical enterprises after post-marking drugs, identify the relationship of ADR monitoring and post-marking drugs study with post-marking drugs reevaluation.

关 键 词：药品上市后再评价 中国 文献分析 

分 类 号：R952[医药卫生—药学]