药品注册研制现场核查中的问题及对策建议
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摘要
目的分析药品注册研制现场核查中常见问题,为提高核查工作质量与工作效率提供合理化建议。方法总结、分析2014年10月至2017年10月辽宁省药品注册研制现场核查工作档案。结果汇总了药学核查中的常见问题,提出典型案例并进行分析。结论建议通过建立分级核查机制、加大对造假的处罚力度、制订研发机构质量管理规范,以及更切实可行的核查规范等方式,真正从源头上解决核查工作中存在的问题,提高核查工作的质量与工作效率。
Objective To analyze the common problems of on-site pharmaceutical verification for drug registration,and to provide reasonable suggestions for improving the quality and efficiency of inspection. Methods The files of on-site verification of drug registration and development from October 2014 to October 2017 in Liaoning Province were summarized and analyzed. Results The common problems in pharmaceutical verification were summarized,and the typical cases were presented and analyzed. Conclusion It is recommended that the problems existing in the verification work should be solved from the source and the quality and efficiency of the verification work should be improved by establishing a hierarchical verification mechanism, increasing the penalties for fraud, establishing standards for quality management of research and development institutions and more practical verification standards.
Objective To analyze the common problems of on-site pharmaceutical verification for drug registration,and to provide reasonable suggestions for improving the quality and efficiency of inspection. Methods The files of on-site verification of drug registration and development from October 2014 to October 2017 in Liaoning Province were summarized and analyzed. Results The common problems in pharmaceutical verification were summarized,and the typical cases were presented and analyzed. Conclusion It is recommended that the problems existing in the verification work should be solved from the source and the quality and efficiency of the verification work should be improved by establishing a hierarchical verification mechanism, increasing the penalties for fraud, establishing standards for quality management of research and development institutions and more practical verification standards.
引文
[1]国务院.关于改革药品医疗器械审评审批制度的意见(国发[2015]44号)[EB/OL].(2015-08-18)[2017-10-22].http://samr. cfda. gov. cn/WS01/CL0051/126861. html.
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[5]贾娜,邹雨,魏晶,等.药品注册生产现场检查发现的问题及思考[J].中国药事,2016,30(6):535-539.
[6]张跃丽,朱巧洪.药品注册生产现场核查助推药品研发全面融入GMP[J].中国药事,2014,28(7):729-731.
[7]田光彩.药品注册现场核查常见问题的分析及建议[J].中国医药指南,2014,12(35):398.
[8]张芳艳.药品注册现场核查的要点及常见问题分析[J].中国药业,2011,20(12):6-7.
[9]马书章,赵杨,王旖旎,等.国家食药监总局通报的飞行检查案例分析对药品研制现场核查关注点的启发[J].首都食品与医药,2017,24(18):5.
[10]吴志红.药品注册现场核查模式存在的问题及对策[J].中国医药指南,2013,11(26):588-589.
[11]吴艳玲.药品注册生产现场检查存在的问题及相关措施分析[J].北方药学,2014,11(11):131-132.
[12]王华,杨悦.医药产业及药品研发的现状与思考[J].中国新药杂志,2011,20(16):1490-1493.
[13]赵志飞,常敬.药品注册现场核查工作现状及思考[J].化工管理,2016,12(35):115.
[14]钟露苗,王铸辉,曾令贵,等.药品注册现场核查工作的现状与思考[J].中国药事,2012,26(3):211-213.
[15]王方敏,朱娟,周坛树,等.药品批准前生产现场检查的国内外比较研究与思考[J].中国新药杂志,2013,22(5):509-512.
[16]黄森,汪丽.药品注册现场核查工作改进建议[J].中国药业,2016,25(8):8-11.
[2]国家食品药品监督管理局.药品注册现场核查管理规定[EB/OL].(2008-05-23)[2017-10-22]. http://www.sda. gov. cn/WS01/CL0844/30285. html.
[3]高鹏.浅析《药品注册现场核查管理规定》[J].中国药事,2008,22(11):942-945.
[4]田晓娟,张苏,王艺霏,等.药品注册研制现场核查常见问题(药学研究原始记录)分析[J].首都医药,2014,12(20):5.
[5]贾娜,邹雨,魏晶,等.药品注册生产现场检查发现的问题及思考[J].中国药事,2016,30(6):535-539.
[6]张跃丽,朱巧洪.药品注册生产现场核查助推药品研发全面融入GMP[J].中国药事,2014,28(7):729-731.
[7]田光彩.药品注册现场核查常见问题的分析及建议[J].中国医药指南,2014,12(35):398.
[8]张芳艳.药品注册现场核查的要点及常见问题分析[J].中国药业,2011,20(12):6-7.
[9]马书章,赵杨,王旖旎,等.国家食药监总局通报的飞行检查案例分析对药品研制现场核查关注点的启发[J].首都食品与医药,2017,24(18):5.
[10]吴志红.药品注册现场核查模式存在的问题及对策[J].中国医药指南,2013,11(26):588-589.
[11]吴艳玲.药品注册生产现场检查存在的问题及相关措施分析[J].北方药学,2014,11(11):131-132.
[12]王华,杨悦.医药产业及药品研发的现状与思考[J].中国新药杂志,2011,20(16):1490-1493.
[13]赵志飞,常敬.药品注册现场核查工作现状及思考[J].化工管理,2016,12(35):115.
[14]钟露苗,王铸辉,曾令贵,等.药品注册现场核查工作的现状与思考[J].中国药事,2012,26(3):211-213.
[15]王方敏,朱娟,周坛树,等.药品批准前生产现场检查的国内外比较研究与思考[J].中国新药杂志,2013,22(5):509-512.
[16]黄森,汪丽.药品注册现场核查工作改进建议[J].中国药业,2016,25(8):8-11.