Real-World Study of Hainan Boao Lecheng International Medical Tourism Pilot Zone:Coordinating the Innovative Development Model of"Research-Evaluation-Production"
This paper summarizes the basic situation of real-world research and application of licensed drugs and medical devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone(Lecheng Pilot Zone).It discusses the regulatory system and research progress of real-world studies in Lecheng Pilot Zone,as well as their role in the innovative development model of"research-evaluation-production".The application of clinical real-world data in the Lecheng Pilot Zone has reduced the economic costs of clinical trials,shortened the research and development timelines for drug devices,and promoted the domestic approval process for urgently needed imported drugs and global innovative drug devices already approved overseas,benefiting a wider range of patients.Meanwhile,the Lecheng Pilot Zone provides a new perspective and pathway for using real-world evidence to support regulatory decision-making for drugs and medical devices,exploring an innovative development model of"research-evaluation-production"for advanced pharmaceutical devices.In addition,the pilot project in Hainan has accumulated valuable experience for further expanding the application scope of real-world data,with the potential for broader promotion and application.
Lecheng Pilot Zonereal-world studylicensed drugs and medical devicesregulatory systeminnovative development model
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