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在法国卫生部主持下,来自企业、质检部门以及高等院校的十七位药学专家组成的专家小组草拟了法国药品生产与管理法规(BPF)1985版。在说明这个法规之前,有必要提一下最近各国相继制订GMP指南的原因。象其它商品一样,药品也是一种工业产品。即使药品生产已经科学化、规范化,但药品与其它物品之间还有一些重要的差别:对药品来说,消费者(即患者)并不能鉴定其质量,他们无法判断药品的疗效、副反应及稳定性。使用药品通常不是由患者自己决定,而是由第三者即医生来决定。患者通常不去或很少去关心药品的费
Under the auspices of the French Ministry of Health, a panel of 17 pharmaceutical experts from enterprises, quality assurance departments and universities and colleges drafted the 1985 version of the French Drug Production and Management Regulation (BPF). Before explaining this regulation, it is necessary to mention the recent reasons why countries have successively developed GMP guidelines. Like other commodities, medicines are also an industrial product. Even though the drug production has been scientifically standardized, there are some important differences between drugs and other items: consumers (ie, patients) can not identify the quality of the drug, they can not judge the efficacy of drugs, side effects and stability. The use of medicines is usually not the patient’s own decision, but by a third person that is the doctor to decide. Patients often do not go or care less about the cost of medicines