完善我国生物制品批签发管理体系的研究  

Study on Improvement of National Lot Release Regulations on Biological Products

作　　者：贾丽丽[1] 杨悦[2] 董关木[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]沈阳药科大学

出　　处：《中国药事》2010年第6期523-530,共8页Chinese Pharmaceutical Affairs

摘　　要：目的以我国生物制品批签发监管系统为研究对象,从机构设立、法规制度建设和批签发实施等方面,对生物制品批签发监管体系的现状进行分析,从管理和技术层面剖析我国生物制品批签发工作中存在的突出问题,对完善和构建我国生物制品批签发管理体系提出改进思路。方法采用文献回顾、调查研究、专家访谈的方法。在综合比较分析的基础上提出完善我国生物制品批签发工作的方向和具体意见。结果我国生物制品批签发系统的框架已建立,但仍存在法律法规不完善、质控实验室资质水平待提高、监管环节落实不到位等不足。结论生物制品批签发已受到各国政府的高度重视,是政府监管当局的重要职责,是保证生物制品安全有效的重要措施,是一项专业性极强的综合管理体系,其构成涉及到法律法规制定、国家实验室对记录的技术审核、关键项目检定、生产检定管理人员的素质等诸多方面。我国的批签发监管工作虽取得一定成绩,但系统内部的细节管理、法律法规的健全和批签发技术指导原则的建立等还需要不断完善和补充。Objective This study was subjected on biological products lot-release regulatory system in China.It analyzed the current status of the organization,rules and regulations,and lot-release regulatory system on domestic and imported biological products,pointed out the major problems of our biological products lot-release work from regulatory and technical aspects,and presented improving suggestions and work thoughts.Methods In the study used retrospective reviewing method and site investigation,and discussion with experts to analyze the biological products lot-release situation in China.Based on comprehensive comparing analysis,the study was concluded in detailed suggestions and work orientation for improving the biological products lot-release work in China.Results This study suggests that Results indicate： Our lot-release system framework has been formed but the lower qualification of quality control laboratory and not complete in practice of all the regulations in our biological products lot-release system.Conclusion Lot release of biological products has been attached great importance to governments.It is an important duty of national regulation authorities,is one important measure to ensure biological products safe and effective.It is a highly professional and integrated regulation system.Its composition related to laws and regulations development,review records and key item test by national laboratory,manufacture and quality control and regulation personnel and other aspects.Our lot-release system framework has been formed.However,the details of in the system,laws and regulations of the construction and lot release guidelines need to continuously improve and supplement.

关 键 词：生物制品 批签发 管理 

分 类 号：R954.5[医药卫生—药学]