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针对当前在药品批准文号管理上出现的擅自变更格式、增加代用字母等状况,卫生部日前发出通知,要求各省、自治区、直辖市卫生行政部门规范药品审批程序,加强药品批准文号的监督管理。 通知指出,省级卫生行政部门审批的药品应使用统一药品批准文号格式,不得擅自更改和增加代用数字或字母,违者应按假药进行查处。药品批准文号和格式为,省简称+卫药准字+(年号)+第××××号。凡是与规定的药品批准文号格式不符的,省级卫生行政部门要在今年12月30日前更换完毕;原药品批准文号的药品销售、使用至明年3月31日。
The Ministry of Health recently issued a circular requiring the health administrative departments of all provinces, autonomous regions and municipalities directly under the Central Government to standardize procedures for the examination and approval of drugs and to strengthen the supervision and administration of the drug approval number, in view of the current unauthorized changes in the format of drug approval number management and the increase of substitute letters. The circular pointed out that the drugs approved by the provincial health administrative departments should use the unified drug approval number format, and may not alter or increase substitute numbers or letters without authorization. Offenders should investigate and deal with counterfeit drugs. Drug approval number and format, the provincial abbreviation + Wei medicine quasi-word + (year) + No. × × × × number. Where the prescribed drug approval number format does not match, the provincial health administrative department should be replaced before December 30 this year; the original drug approval number of drug sales, use until March 31 next year.