一、审批依据1、《中华人民共和国药品管理法》;2、国家药监局《开办药品生产企业暂行规定》。二、申报条件凡开办药品生产企业的必须具有国内未生产的二类以上(含二类)的新药证书,中药生产企业具有二个以上(含二个)的三类新药证书也可申请办理,生产生物工程产品还要符合 I. Approval basis 1. “People’s Republic of China Drug Administration Law”; 2. State Food and Drug Administration “Provisional Regulations on the Establishment of Pharmaceutical Production Enterprises.” Second, the declaration conditions where the establishment of pharmaceutical production enterprises must have a domestic production of more than Class II (including Class II) new drug certificate, Chinese medicine production enterprises have more than two (including two) three types of new drug certificates can also apply for, Production of bio-engineering products also meets