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时下,药品管理体制改革正日益推进,其标志就是各省相继成立药品监督机构,多称之为“药品监督管理局”,此称呼笔者认为有欠妥之处,故商讨。1 建立于药品生产、经营、使用之外的,目前各省正在挂牌的有执法职能的药品监督机构应称之为“药品监督局”;负责药品监督、执行国家政策、有权处罚当事人或单位,是执法机关;此项工作纯属监督范畴,不应有“管理”二字。2 建立于药品生产、经营、使用系统之内的辖管药品生产、经营、使用各环节的企业机关应称之为“医药管理局”;负责对下属各单位实行规范管理。此项工作属行业内部管理。
Nowadays, the reform of the drug administration system is being promoted day by day. The sign of this is that the provinces have set up drug supervision agencies one after another, often called the “Drug Administration,” which the author believes is defective. 1 Drug regulatory agencies with law enforcement functions currently listed in all provinces except for the production, operation and use of pharmaceutical products shall be referred to as “Drug Administration Supervision Bureau”; they shall be responsible for the supervision of drugs, implement the national policies, have the authority to punish the parties or units, It is a law enforcement agency. This work is purely a supervisory category and there should be no “management”. 2 An enterprise organ that is established under the system of production, operation and use of pharmaceuticals and that controls the production, operation and use of pharmaceuticals shall refer to it as the “Medical Administration Bureau”; it shall be responsible for the standard management of its subordinate units. This work is the industry’s internal management.