仿制药研发的进度管理与控制措施

Progress Management and Control Measures of Generic Drug Research and Development

随着中国医药改革,从药审改革到一致性评价,从国家医保局的成立到“4+7”带量采购的正式推进,仿制药企业竞争愈加激烈。因此,如何通过有效的管理方法,加速仿制药研发和使用进程,缩短产品的开发周期,成为企业抢占仿制药市场先机的必备武器。文章阐述了仿制药研发的进度管理与控制的意义,并针对目前仿制药研发进度管理存在的一定问题进行探究,建议通过识别风险、加强干系人分析、建立分级会议管理制度、提高专业技术水平及专利挑战能力、制定合理的里程碑计划、控制节点的达成率等措施改善进度管理。

With the reform of China’s pharmaceutical,from the drugs review to the consistency evaluation,from the establishment of the National Healthcare Security Bureau to the formal promotion of the“4+7”volume procurement,competition among generic drugs pharmaceutical companies is f ierce.Therefore,how to use through effective management methods,accelerate the process of generic drug development,and shorten the product development cycle,become an essential weapon for enterprises to seize the opportunity of generic drug market.This paper expounds the signif icance of the schedule management and control of generic drug development,and probes into some existing problems in the progress management of generic drug development.It is suggested to improve the progress management by identifying risks,strengthening stakeholder analysis,establish a hierarchical conference management system,improve the professional technical level and patent challenge ability,formulating reasonable milestone plans,controlling the achievement rate of nodes and other measures.