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1985年卫生部根据《药品管理法》颁布了《新药审批办法》后,新药的审批管理进入到法制化阶段。但是在新药审评过程中,发现在药品的人体生物利用度试验方面存在许多问题,从而难于对药品的质量进行分析,无法进行正确的评价,为此卫生部药品审评办公室制定了药物制剂人体生物利用有度试验指导原则,并已征求了部分专家教授的意见,为了更好、更完善地执行此原则,我们将该原则刊登出来,广泛征求各方面的意见,以利于修改。读者中如有建议可直接与卫生部药品审评办公室赵明联系。
After the Ministry of Health promulgated the Measures for Examination and Approval of New Drugs in accordance with the Drug Administration Law in 1985, the examination and approval of new drugs entered the legal phase. However, during the review of new drugs, many problems have been found in human bioavailability testing of drugs, so that it is difficult to analyze the quality of drugs and can not be correctly evaluated. Therefore, the Drug Evaluation Office of the Ministry of Health has formulated the drug formulation of human body We have consulted with some experts and professors. In order to better and better implement this principle, we published the principle and solicited opinions from all sectors to facilitate the amendment. If readers have suggestions, they can contact with Zhao Ming, the drug review office of the Ministry of Health directly.