NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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In order to make up for the talent vacancy in the domestic real-world research field, assist the exploration of new tools, new methods and new standards for real-world research, and promote the construction of the drug and medical device base of the State Food and Drug Administration, the careful guidance of the State Food and Drug Administration and the vigorous efforts of the Hainan Provincial Government With the support, Hainan Real World Data Research Institute has gathered high-quality teachers from Peking University, Sichuan University, Wenzhou Medical University and other institutions of higher learning. Since 2021, it has cooperated with Hainan University to open the country's first "Real World Data Application" for the first time. The training point for postgraduates and postgraduates of the training goal, the enrollment majors cover biology, information and communication engineering, biomedicine, electronic information, etc., aiming at cultivating multidisciplinary and interdisciplinary talents, providing a steady stream of intelligence for real-world research and development Support and build a high ground for talents gathering in real world research in China.

Latest News! Pilot Drugs Included into Lecheng’s Real-world Data Application Increased to Nine
Recently, 5-Aminolevulinic Acid Hexyl Ester Hydrochloride injection produced by Photocure ASA Company has been included among the pilot drugs, making the number of pilot drugs in Lecheng’s real-...
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Johnson&Johnson Catalys Precision Laser System Approved and Introduced with Real-world Data
On November 26, as reviewed by the NMPA, the registration of Johnson&Johnson Vision Catalys precision laser system was approved, which was the second innovative medical product to be approved base...
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Two Products of Boston Scientific of the US Approved for Registration with Real-world Data of Lecheng
On March 3, the pilot program of real-world data application of Lecheng witnessed a new breakthrough. The NMPA reviewed and approved the registration application of thermal steam treatment equipment a...
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NMPA Conditionally Approves the Marketing of Pralsetinib Capsule
Recently, through the prioritized review and approval procedure, the NMPA conditionally approved the marketing of Pralsetinib capsule, a Class 1 innovative drug declared by Blueprint Medicines Corpora...
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● Pilot Program of Real-world Study Boosted by Innovation in Lecheng Pilot Zone by GAO Guobiao
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● Exploration on the Marketing Approval of Innovative Medical Products at Boao Lecheng by REN Yan
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● Building Real-world Study Model Based on Licensed Medical Product Policy by YAO Minghong
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● Exploration of Data Compliance in the Process of Real-world Study in Lecheng Pilot Zone by LI Yanlong
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Opinion: Contrary to what the FDA says, Chinese regulators do care about clinical data integrity
Editor’s note: The FDA recently cited a report saying that “80% of clinical trial data from China were ‘fraudulent or substandard’.” Yao argued that the view is outdated ...
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Protecting the accuracy of clinical trial data in China
The Chinese government has signalled its commitment to ensuring the quality of clinical trials conducted in China. In 2015, the China Food and Drug Administration (CFDA) announced a plan to protect da...
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Opinion: Contrary to what the FDA says, Chinese regulators do care about clinical data integrity
By Yao ChenEditor’s note: The FDA recently cited a report saying that “80% of clinical trial data from China were ‘fraudulent or substandard’.” Yao argued that the view i...
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Suitable Study Design and Statistical Analysis Methods for Real-World Study of Licensed Medical Devices in Lecheng
Cite this articleCao Han, Yao Chen*, Yan Xiaoyan, Yu Yongpei, Shang Meixia. Exploration of Design Types and Statistical Analysis Methods of Licensed Medical Device Clinical Research Based on Boao Lec...
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