论我国转基因动物生物反应器制药的法律监管  

On the Legal Supervision of Transgenic Animal Bioreactor Pharmacy in China

作　　者：刘旭霞[1] 沈大力[1] 耿宁[1] 

机构地区：[1]华中农业大学文法学院,湖北武汉430070

出　　处：《青岛农业大学学报（社会科学版）》2014年第4期61-65,共5页Journal of Qingdao Agricultural University(Social Science)

基　　金：中央高校基本科研业务费专项(2011RW002);中央高校基本科研业务费专项(2013SC42)

摘　　要：近年来,通过转基因动物生物反应器生产药物成为生物技术开发利用的热点。但转基因动物生物技术应用的潜在收益和风险并存,现有《药品管理法》及其实施条例,以及其他相关药品管理办法均未对转基因动物生物反应器药品监管进行专门规定,制度上存在明显漏洞。因此,有必要建立转基因动物生物反应器制药临床前实验制度、临床实验质量管理制度、新药上市许可制度、药品生产与市场准入制度,及上市后不良反应报告和召回制度,促使转基因动物生物反应器制药走上法制化发展轨道。In recent years,it has become a hot spot to produce medicines with transgenic animal bioreactors in the development and utilization of biotechnology. But the potential benefits and risks coexist in the application of transgenic animal biotechnology. There are no special provisions in the present ＂Pharmaceutical Administration Law of the People＇s Republic of China＂ and its implementing regulations, and other related pharmacy management measures. There are obvious loopholes in the legal system. Therefore, it is necessary to establish a comprehensive system including a preclinical trial system, a clinical quality management system, new pharmacy licensing system, pharmaceutical production and market access system,and post -marketing adverse reaction reporting and recalling system, to legalize the development of transgenie animal bioreacotrs pharmacy .

关 键 词：转基因动物生物反应器 药品生产经营 市场准入 监管制度 

分 类 号：DF413[政治法律—经济法学]