药品生产企业、经营企业和药品的审批程序将得到简化,长期以来企业反映审批环节多、审批体制复杂的问题有望得到解决。提请全国人大常委会第十七次会议审议的药品管理法修正案草案,体现了政府机构改革的成果,对药品生产企业、经营企业和药品的审批程序作出了修改和完善。按照现行药品管理法的规定,开办药品生产企业、经营企业须药品生产经主管部门和卫生行政部门两道审查,分别取得药品生产企业合格证和许可证、药品经营企业合格证和许可证,赁两证办理工商登记、领取营业执照,有了“两证一照”方可营业;生产已有标准的药品须经卫生行政部门征求药品生产经营主管部门意见后审核批准。 The examination and approval procedures for drug manufacturers, operating companies, and pharmaceuticals will be simplified. For a long period of time, companies are expected to resolve the issue of a large number of examination and approval procedures and complex approval systems. The draft amendment to the Drug Administration Law that was submitted to the 17th meeting of the Standing Committee of the National People’s Congress for the National People’s Congress for the National People’s Congress (NPC) has reflected the results of the reform of the government agencies, and revised and improved the examination and approval procedures for drug manufacturers, operating companies, and drugs. In accordance with the provisions of the current Drug Administration Law, the establishment of pharmaceutical production enterprises and business enterprises must be subject to the examination of drug production by the competent authority and the administrative department of health. The certificates and licenses of pharmaceutical manufacturers, the certificates and licenses of drug manufacturers must be obtained respectively. Two licenses for industrial and commercial registration, business license, with “two cards one license” can be open; the production of existing standards of the drug must be sought after by the health administrative department of the drug production and management departments for approval.