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1980年5月30日日本政府卫生福利部发布了PAB 698号通告,对呈送卫生福利部审批的处方药品必须按药物的类型呈送有关资料。现将PAB 698号通告对药品的分类及每类药品需申报的资料介绍如下:1 含新有效成分的药品这类药物指含有在目前已获准生产或引进的药品中尚不含该有效成分的处方药品,或所含的这种成分迄今为止一直作非药用目的,现申报作为药用的药品。该类药物必须呈送下列各项资料:
On May 30, 1980, the Japanese government’s Ministry of Health and Welfare issued Circular No. PAB 698, which prescribes that the prescribed drugs submitted for examination and approval by the Ministry of Health and Welfare must be submitted according to the type of drugs. The PAB 698 Circular is now available for the classification of pharmaceuticals and the information to be reported for each type of pharmaceutical as follows: 1 Pharmaceuticals containing the new active ingredient These pharmaceuticals contain substances that do not yet contain the active ingredient in the currently approved pharmaceuticals Prescription drugs, or contained in such ingredients, have been non-medicinal for so far and are now declared as medicinal. Such drugs must be presented with the following information: