我国疫苗安全监管法律问题研究.pdfVIP

摘 要 作为一种特殊的药品种类，疫苗是当前社会已知的预防和控制传染性疾病的 最为经济有效的手段。疫苗的安全与否严重影响着广大民众生命健康安全，意义 重大。近年来，我国疫苗安全事件频发，显示了我国疫苗安全监管体系还存在诸 多不足。 本文以疫苗安全监管作为研究对象。首先介绍了本文的选题背景与选题意 义，并对国内外研究动态进行了介绍与评析。 其次通过分析我国疫苗安全监管中包含疫苗研制和注册阶段、生产和批签发 阶段、流通阶段和使用阶段四个主要阶段在内的全过程环节，结合长春长生生物 疫苗造假案件和新冠疫苗的研制，介绍了我国疫苗安全监管领域立法现状及存在 的问题，探究了各个环节存在的监管问题和面临的挑战。 接着介绍了国外疫苗安全监管的法律制度，通过借鉴国外先进的做法，从中 为我国疫苗安全监管制度的完善提出值得学习的经验。并探析了我国疫苗安全监 管存在问题的具体原因主要在于疫苗安全监管领域立法不完善、监管队伍综合素 质有待提高及监管信息化建设不成熟 最终探讨了完善我国疫苗安全监管的具体措施，总结如下：一是完善疫苗安 全监管领域立法；二是积极完善疫苗安全监管各项制度；三是强化监管部门信息 化监管能力和检验检测能力；四是建立健全疫苗救济保障制度。 关键词：疫苗安全；疫苗管理法；疫苗监管；制度创新 I Abstract As a special kind of medicine, vaccine is currently the most cost-effective means of preventing and controlling infectious diseases known to the society. The safety of the vaccine seriously affects the lives, health and safety of the general public and is of great significance. In recent years, the frequent occurrence of vaccine safety incidents in my country shows that there are still many deficiencies in my countrys vaccine safety supervision system. This article takes vaccine safety supervision as the research object. Firstly, it introduces the background and significance of this topic, and introduces and analyzes the research trends at home and abroad. Secondly, by analyzing the whole process of Chinas vaccine safety supervision, including the four major stages of vaccine development and registration, production and batch issuance, circulation and use, combined with Changchun Changsheng biological vaccine fraud cases and the development of new crown vaccines, Introduced the legislation status and existing problems in the field of vaccine safety supervision in China, and explored the supervision proble