Research on drug registration management of small and medium sized pharmaceutical enterprises in China based on SWOT analysis

LI Xia; TIAN Li-juan

doi:10.20251/j.cnki.1003-3734.2025.18.003

Abstract：Objective:To study the drug registration work of small and medium-sized pharmaceutical enterprises applying SWOT analysis method,providing references for pharmaceutical enterprises to strengthen drug registration management and promote the products to be marketed successfully.Methods:SWOT analysis was used to analyze the strengths,weaknesses,opportunities and threats of small and medium-sized pharmaceutical enterprises for drug registration management,and to establish SWOT matrix and drug registration strategy for such enterprises.Suggestions were put forward to strengthen the drug registration.Results:The main weaknesses faced by small and medium-sized pharmaceutical companies in the process of drug registration include insufficient research and development comprehensive ability,financial pressure,regulatory interpretation ability,quality management system,clinical trial resources,communication with regulators and intellectual property protection awareness.At the same time,small and medium-sized pharmaceutical enterprises have internal advantages,including flexible decision-making mechanism,cost control ability,high market focus and government policy support.In terms of the external environment,the opportunities faced by small and medium-sized pharmaceutical enterprises include the expansion of emerging markets,policy support and scientific and technological progress,etc.The threats include changes in regulations and policies,intellectual property protection,market competition,and changes in the international landscape.Conclusion:Small and medium-sized pharmaceutical enterprises must take into account the dynamic nature of the external environment and flexibly adjust the drug registration strategy to achieve the best drug registration path and market competitiveness.At the same time,enterprises should take drug registration as the core,combine their own resources and market positioning,and flexibly use a variety of strategies.