Recently, China’s Hainan Free Trade Port Boao Lecheng Pioneer Zone (hereinafter referred to as Boao Lecheng Pioneer Zone) made an appearance on the world’s top landmark – Times Square in New York, USA, showcasing the world the elegance of China’s only medical special zone, highlighting the openness and self-confidence of Hainan’s free trade port, and it sincerely invites everyone to visit Boao Lecheng in Hainan for inspection, health care, and leisure.
China has given Boao Lecheng Pioneer Zone preferential policies for licensed medical treatment, licensed operation, licensed international medical exchange and licensed research. The most advanced medical instruments in the world can be used in Lecheng, and Lecheng provides access to the international cutting-edge medical scientific and technological achievements. At present, 20 medical institutions in the Pioneer Zone are in operation and more than 10 are under construction or in the pipeline.
Clinical real-world data application pilot work is an important part of China’s drug regulatory scientific action plan, and it represents one of the most significant institutional innovations in Hainan Province. With the application of the real-world data-assisted clinical evaluation method in the Lecheng Pioneer Zone, global innovative drug and machinery products approved for registration in China have made significant breakthroughs one after another, and 23 drug and machinery products have been included in the real-world data application pilot, of which 9 are drugs and 14 are medical devices.
Over 200 innovative pharmaceutical devices, many of which have not been listed for clinical use in China yet, have been introduced by the top 30 multinational pharmaceutical and medical device companies in close cooperation with Lecheng, becoming the most important channel for international pharmaceutical devices to enter the Chinese market.