Innovative Regulatory Model for Pharmaceuticals and Medical Devices to Support the Development of Hainan Free Trade Port-Review and Prospect of the Fifth Anniversary of Clinical Real World Data Application Pilot in Boao Lecheng,Hainan
With the rapid development of information technology,real world data has gradually become an important tool for global pharmaceutical regulatory decision-making.The role of real world studies in review and approval of drugs and medical devices is increasingly valued by regulatory agencies in various countries and regions.In 2019,the National Medical Products Administration and the People's Government of Hainan Province launched a pilot program for real world data applications in the Boao Lecheng Pilot Zone in Hainan,to promote the use of real world studies in regulatory decision-making for drugs and medical devices.Over the past five years of pilot work,the Lecheng Pilot Zone has achieved breakthrough results in advancing regulatory decision-making for drugs and medical devices supported by real world evidence,through the establishment of a real world data platform and innovative research methods.This includes the release of multiple guidance principles related to real world studies,the use of Lecheng real world evidence to support the registration and listing of multiple innovative drug and medical device products,etc.These efforts have promoted international regulatory cooperation in drugs and medical devices and contributed to the development of the healthcare industry,showcasing China's commitment to the advancement of global real world studies.
drugs and medical devicesregulatory decision-makingreal world data applicationspilot programsachievements
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