新药上市过程中风险因素探寻与应对策略研究

Research on Risk Factors and Coping Strategies in the Process of New Drugs

摘要: 随着《“健康中国2030”规划纲要》、《“十三五”国家药品安全规划》等政策的提出，国家对于药品安全的重视程度不断加大，对于新药上市过程中的风险控制要求不断提高。新药上市大体可分为六个阶段，每一阶段中均伴随着大量风险。而任何一个阶段的任何一个风险均存在着使整个新药研究项目失败的可能性。本文将主要通过文献综述的方式，结合多篇相关文献进行分析；同时将辅以案例分析法，对相关问题进行进一步的论述。探寻新药上市过程中存在的风险，并探寻相关风险的应对策略。企业应严格遵守相关政策法规，建立全过程风险管控体系及相匹配的内控体系，包括但不仅限于制度、办法、细则和流程，以科学主动管控风险。

Abstract: With the “Healthy China 2030 Plan Outline” and “13th Five-Year Plan National Drug Safety Plan” and other policies proposed, the government has paid more attention to drug safety, and the risk control requirements for listing new drugs have been continuously improved. The listing of new drugs can be broadly divided into six phases, each of which is accompanied by a large number of risks. Any risk at any one stage has the potential to defeat the entire new drug research project. This article will use the method of literature review, combined with a number of related literature for analysis to explore the risks involved in the listing of new drugs and to explore relevant risk response strategies. Enterprises should strictly abide by relevant policies and regulations, establishing a full-process risk management system and rules and regulations to avoid risks.