The Hainan Boao Lecheng International Medical Tourism Pilot Zone has introduced 319 clinically urgently needed overseas drugs and medical devices with special licenses since receiving permission in 2018. According to the Hainan Provincial Information Office, the number of approved licensed medical devices increased by 62% year-on-year (YOY) in 2022, and the number of users increased by 147% YOY.<\/p>\n\n\n\n
Boao Lecheng: Main Channel for Early Access to Latest Drugs and Devices<\/strong> Average Approval Time and Real-World Data Application<\/strong>
Boao Lecheng serves as the primary channel for the world’s latest drugs and medical devices to gain early access to Chinese patients. In April this year, the National Medical Products Administration (NMPA), Hainan Medical Products Administration (MPA) bureau, and Lecheng Medical Pilot Zone Administration jointly released the \u201cImplementation Measures for Pre-communication of Clinical Real-World Data Application of Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone (Trial)\u201d.<\/p>\n\n\n\n
The document revealed that the average approval time for licensed drugs and medical devices in Lecheng is just 1.6 working days. Authorities aim to clarify the path for using real-world data generated in Lecheng for product registration on the mainland, consolidating responsibilities and establishing a safety risk prevention and control network for the use of licensed drugs and devices.<\/p>\n\n\n\n