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我国目前有6300多家医药企业,年申报新药上万种,经国家药监局批准,每年至少要进行5000个需健康受试者参与的药品临床试验,有800种左右的新药获准研发上市,参与试药的正常人及患者有50万之众。然而,一个严肃的现实摆在面前,我国还没有人体实验方面专门的法律,试药一旦受到伤害,或出现纠纷,试药人损失由谁赔偿?相关的赔偿按照什么样的标准执行?在目前试药人权益保护尚是法律空白的情况下,不久前,南京市鼓楼区法院审理了这样一起特殊的试药官司案件并作出了公开判决。
At present, there are more than 6,300 pharmaceutical enterprises in our country, declaring thousands of new drugs every year. With the approval of the SFDA, at least 5,000 clinical trials of drugs involving healthy subjects are required every year. About 800 kinds of new drugs are approved for research and development, There are 500,000 people in normal people and patients involved in the trial. However, in the face of a serious reality, there is no specific law on human experiments in our country. If the reagent is hurt or there is a dispute, who will compensate for the loss of the reagent and the compensation according to what kind of standards? At present, The trial drug rights protection is still a legal blank, not long ago, Nanjing Gulou District Court heard such a special case of trial cases and made a public verdict.