药品是一种特殊的商品,有其特殊的规范和要求。药品的生产、销售必须得到国家药品管理部门的批准,这是众所周知的。在药品审批中,还包括对药品说明书内容的审查,因为药品说明书内容是涉及药品的法律依据之一,是不可随意改动的。 前不久,上海发生了国内首例涉及药品说明书问题的服药者状告药厂的赔偿案。其经过是:患者胡爱苗于1995年8月18日去上海市第九人民医院门诊,被诊断为三叉神 Medicines are a special kind of product that has its own special specifications and requirements. It is well-known that pharmaceutical production and sales must be approved by the State Drug Administration. In the drug approval, but also the contents of the drug review manual, because the drug manual content is one of the legal basis for the drug is not free to change. Not long ago, there was a case of compensation for the first pharmaceutical company in Shanghai that sued the pharmaceutical company for the drug product issue. Its after: Hu Ai Miao in August 18, 1995 to the Ninth People’s Hospital of Shanghai outpatient, was diagnosed with trigeminal God