关键词: 海南自由贸易港, 临床急需进口药品, 首次申报, 常见问题

Abstract: The Overall Plan for the Construction of Hainan free trade port proposes to comprehensively build a high-level free trade port with strong international influence by the middle of this century， and to enhance the development level of Boao Lecheng International Medical Tourism Pilot Zone in the modern industrial system.Against the backdrop of the construction of the Hainan free trade port， this article reviews the initial declaration of clinically urgent imported drugs in Hainan province from 2022 to 2024. Common problems in modules such as application forms， qualification certificates， usage plans for imported drugs， and expert information are analyzed. The common problems are manifested in four aspects： missing data， unclear data， conflicting data， and insufficient compliance. In response to the deficiencies in the application materials and in combination with the actual supervision of imported drugs urgently needed in clinical practice in Hainan province， from the perspective of regulatory authorities and medical institutions， regulatory authorities can create a good business environment by promoting the establishment and implementation of standardized templates for application materials， constructing long-term interactive mechanisms， and actively contributing to the development of the industry； medical institutions can fully exert their main responsibility for declaration and actively improve the quality of declaration materials by establishing a standardized document system and improving the control of the entire declaration process； regulatory authorities and medical institutions are working together to empower the high-quality development of the pharmaceutical and health industry.
     ［Key Words］ 

Key words: Hainan free trade port, Clinically urgent imported drugs, First declaration, Common problem