企业新药研发的风险控制策略  

Analysis of Risk Control Strategy of New Drug Research and Development in Enterprises

作　　者：吴旭璇 黄哲[1] WU Xu-Xuan;HUANG Zhe(Shenyang Pharmaceutical University,Shenyang 110000,China)

机构地区：[1]沈阳药科大学,沈阳110000

出　　处：《中国药物经济学》2024年第7期113-116,共4页China Journal of Pharmaceutical Economics

摘　　要：新药研发项目存在着多种风险,包括市场风险、技术风险、法规与合规风险、财务风险。在应对这些风险时,研发团队应采取一系列策略。加强市场调研、需求预测、竞争分析降低市场风险;建立科学技术评估体系应对技术风险;遵守法规与合规要求减少法规风险;建立稳健财务管理体系可以应对财务风险。只有通过合理的风险规避和管理策略,新药研发项目才能取得成功并为社会带来更多的医疗福祉。There are many risks in new drug research and development projects,including market risk,technical risk,regulatory and compliance risk,and financial risk.In dealing with these risks,R&D teams should adopt a range of strategies.Strengthen market research,demand forecasting,competition analysis to reduce market risk;Establish a scientific and technological evaluation system to cope with technological risks;Compliance with regulatory and compliance requirements to reduce regulatory risk;The establishment of sound financial management system can deal with financial risks.Only through reasonable risk avoidance and management strategies can new drug development programs succeed and bring more medical benefits to society.

关 键 词：风险控制 新药研发 响应策略 

分 类 号：R917[医药卫生—药物分析学]