常州市仿制药一致性评价工作分析与对策

Analysis and Countermeasure of Consistency Evaluation Work for Generic Drugs in Changzhou

2016年初《关于开展仿制药质量和疗效一致性评价的意见》正式发布,这标志着一致性评价工作正式启动。从制药产业整体经济产值来看,仿制药仍是常州医药产业发展的重点,故此次一致性评价工作对常州本地药企影响较大。在对一致性评价工作国内整体进展及常州市所面临形势分析的基础上,指出现阶段常州市一致性评价工作面临的共性问题并提出科学、合理化建议,加速推进常州医药产业转型升级。

At the beginning of 2016,the"Opinions on the Evaluation of the Quality and Efficacy of Generic Drugs"was officially released,which marked the official launch of the consistency evaluation work.From the perspective of the overall economic output value of the pharmaceutical industry,generic drug is still the focus of the development of Changzhou's pharmaceutical industry.Therefore,the consistency evaluation work has a great impact on local pharmaceutical companies.Based on the analysis of the overall progress of the nation-wide consistency assessment work and the specific situation of Changzhou,this article pointed out the common problems faced by Changzhou in the consistency evaluation work and put forward scientific and rational suggestions to accelerate the transformation and upgrading of pharmaceutical industry in Changzhou.