仿制药一致性评价作为提高仿制药质量的重要措施，对国内质量参差不齐的仿制药进行优胜劣汰、促进药品市场有序竞争和医药产业升级、提高行业集中度、增强中国制药企业的国际竞争力及为消费者提供高质量的放心药有重要意义。开展仿制药一致性评价是制药企业目前最重要的工作之一，企业如何应对这种行业的变革，解决开展一致性评价中面临的问题，保持企业稳定运营和可持续发展，是企业当前需要研究和探讨的问题。 本文的研究对象为C企业，是一家集研发、生产和销售为一体的仿制药企业。研究目的是探讨在国家仿制药一致性评价的要求下，C企业进行一致性评价工作面临和存在的问题，并分析原因，提出相应的策略建议，使C企业能够应对当前一致性评价工作中面临和存在的问题，保质高效完成产品一致性评价工作，抓住市场机遇，同时也为行业内制药企业如何应对仿制药一致性评价的影响提供参考建议。本文采用文献研究法研究国内外相关文献，阐述国内外一致性评价情况、一致性评价对企业的影响及企业应对方法；通过对100名制药企业中涉及一致性评价工作的人员进行问卷调查，梳理制药企业开展一致性评价工作面临和存在的问题，并以此为依据，设计对C企业的访谈提纲，通过对C企业管理层10人的访谈，梳理C企业一致性评价工作面临和存在的问题。通过对企业竞争战略理论和质量管理理论的研究，分析了C企业的竞争环境和一致性评价过程的质量管理问题。最后提出C企业应对一致性评价影响的策略建议。开展一致性评价是C企业当前最重要的工作之一，关系到企业的可持续发展，意义十分重要。 从C企业参评品种选择、参评品种市场定位、质量管理、临床试验、投入资金、进度、管理沟通及人力资源等方面进行分析，提出问题解决策略，得出以下结论：为有效进行一致性评价工作，C企业应确定参评品种，对参评品种进行准确市场定位，避免产品同质化；为顺利的开展质量研究工作，建立评价过程的质量管理体系；提前布局临床试验工作，保证临床试验顺利完成；通过严格生产成本控制和战略选择放弃做好费用控制；重视策略设计，推进一致性评价进度，抓住市场需求与机遇；建立一致性评价工作团队，提高部门间沟通效率；培养和引进研发人才，推动一致性评价保质高效开展，从而按时保质高效的完成一致性评价工作，使C企业抓住一致性评价带来的市场机遇。

Consistency evaluation of generic drugs is an important measure to improve the quality of generic drugs. It is of great significance to eliminate the inferior and the superior of generic drugs with uneven quality in China, to promote orderly competition in drug market and upgrading of pharmaceutical industry, to improve industry concentration, to enhance the international competitiveness of Chinese pharmaceutical enterprises and to provide high-quality reassuring drugs for consumers. Consistency evaluation of generic drugs is one of the most important tasks for pharmaceutical enterprises at present. How to deal with the changes in this industry, solve the problems faced in the process of consistency evaluation, and maintain stable operation and sustainable development of enterprises are the problems that enterprises need to study and discuss at present. The research object of this paper is Enterprise C, which is a generic pharmaceutical enterprise integrating R&D, production and sales. The purpose of this study is to explore the problems faced by C enterprises in consistency evaluation under the requirements of national generic drug consistency evaluation, analyze the reasons and put forward corresponding strategies and suggestions, so that C enterprises can cope with the problems faced in current consistency evaluation, complete product consistency evaluation with high quality and efficiency, seize market opportunities, and at the same time for the industry. How to deal with the impact of conformity evaluation of generic drugs for pharmaceutical enterprises to provide reference suggestions. This paper uses literature research method to study the domestic and foreign relevant literature, elaborates the situation of consistency evaluation at home and abroad and the impact of consistency evaluation on enterprises and the ways to deal with enterprises; through questionnaire survey of 100 pharmaceutical enterprises'staff involved in consistency evaluation, combs the problems faced by pharmaceutical enterprises in carrying out consistency evaluation, and based on this, designs an interview with C enterprises. Talking about outline, through interviews with 10 people in C enterprise management level, this paper combs the problems faced by C enterprise consistency evaluation from the interview results. Through the research on the theory of enterprise competition strategy and quality management, this paper analyses the quality management problems in the competitive environment and consistency evaluation process of C enterprise. Finally, it puts forward some suggestions for C enterprises to cope with the impact of consistency evaluation. Consistency evaluation is one of the most important tasks of C enterprise at present, which is related to the sustainable development of the enterprise. It is very important for enterprises to enhance their ability to cope with changes in the competitive environment. Based on the analysis of the causes of the problems in the selection of evaluation varieties, market positioning, quality management, clinical trials, investment, progress, management communication and human resources, this paper puts forward some suggestions for solving these problems. It is concluded that in order to effectively carry out the consistent evaluation, C enterprises should determine the evaluation varieties, make accurate market positioning for evaluation varieties, and avoid them. Product homogenization; Establishment of quality management system for evaluation process to carry out quality research smoothly; Layout clinical trials ahead of schedule to ensure the successful completion of clinical trials; Abandon cost control and waste reduction through strict production cost control and strategic choice; Pay attention to strategy design, promote the progress of consistency evaluation, seize market demand and opportunities; Establish consistency evaluation Work team, improve the efficiency of inter-departmental communication; train and introduce R&D personnel, promote consistency evaluation to carry out quality and efficiency, so as to complete consistency evaluation on time, quality and efficiency, so as to enable C enterprises to seize the market opportunities brought by consistency evaluation.