我国药品安全监管改革路径探析∗

摘要

To weigh the safety and efficacy of the drug is the goal that people have been working for. In order to reap huge profits, some pharmaceutical producing enterprises tend to adopt illegal means of counterfeiting because of the profit-driven of market economy. Therefore, we should deepen reform of the drug safety supervision and constantly improve the level of drug safety regulation from the strengthening of external control. Examine the historical limitations of the drug safety supervision system and the new requirements of drug safety government regulation in our country. Explore and summarize the deficiencies in the security field of the drug present in gov⁃ernment regulation. At present stage, we should strengthen risk awareness, construct drug safety laws and regulations and reform our government regulators. Furthermore, we should perfect the drug recall system, give full play to the role of the network media in monito⁃ring drug safety on the basis of perfecting the drug safety supervision system.%在药品的安全性和有效性之间进行平衡是我国药品监管的目标。由于市场经济的逐利性，一些药品生产企业为了牟取暴利，往往采取制假贩假的违法手段，对此要从加强外部管制入手，深化药品安全监管改革，不断提高药品安全监管水平。考察我国药品安全监管体制的历史局限性以及新时期药品安全监管的现实需求，借鉴国外药品安全监管的实践经验，现阶段我国应加强药品安全法律制度建设，进行政府药品安全监管机构改革，强化药品安全风险管理，健全药品召回制度，充分发挥网络媒体在药品安全监督方面的积极作用。