论文部分内容阅读
1990年4月在对1976年8月24日药品法补遗的第四条款中已明确了植物药的法律地位。各种药物成品都必须获得销售批准。草药成品也和其它药物成品一样,其质量、安全和效用要符合同样的标准。草药成品的销售可以通过三种途径实现: 1.通过老药的评估和合法化程序 1987年注册的成药确拥有临时性销售许可,允许在市场上销售到1990年4月底。这些药的药学评估主要依据文献数据并由特别专家委员会完成。这些评价文档编撰成专集,并据此从本年开始对这些药物进行审批。 2.标准的销售许可审批对健康没有直接或间接危害的药品,只
In April 1990, the legal status of botanical drugs was clarified in article IV of the Supplement to the Medicines Act of 24 August 1976. Various pharmaceutical products must be approved for sale. Herbal finished products, like other finished pharmaceutical products, are of the same quality, safety and efficacy. Sales of herbal finished products can be achieved in three ways: 1. The assessment and legalization of old medicines The registered medicines registered in 1987 did have temporary sales licenses that were allowed to be marketed until the end of April 1990. Pharmacological evaluation of these drugs is based mainly on the literature data and is done by a special panel of experts. These evaluation documents have been compiled into a collection and accordingly the approval of these drugs has been conducted from this year onwards. 2. The standard sales license approves drugs that have no direct or indirect health effects, and only