First NMPA Approval by Real World Data in Hainan

On March 26, 2020, NMPA approved Allergan, Inc.’s registration of “XEN” and the clinical real-world evidence collected in Hainan Boao Lecheng during the registration was used to evaluate racial differences. Eye & ENT Hospital of Fudan University’s chief physician of ophthalmology — Professor SUN Xinghuai, director of Beijing Tongren Hospital’s Eye Center –Professor WANG Ningli and other experts suggested that the launch of this product fills the gap in the field of glaucoma in minimally invasive surgery and provides a new treatment approach for glaucoma treatment in China, which will promote scientific research and innovation in the field of ophthalmology in China.

“XEN” were approved for use in April 2019 in Hainan Boao Lecheng Pilot Zone in accordance with the policy of clinically urgent needed imported medical devices. From December 2019, the domestic clinical real-world evidence for evaluating racial differences was collected in accordance with the “Preliminary Plan for Collecting Data of Clinical Application of Clinically Urgent Needed Imported Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone”. Professor QU Jia, director of the International Optometry and Ophthalmology Center of Boao Super Hospital and Professor SUN Xin, director of the Chinese Cochrane Center of West China Hospital, Sichuan University, suggested that “XEN” is the first medical device products in China approved through the route of real-world evidence assisting clinical evaluation. It will be a good start for the application of real-world evidence in the medical device registration and approval in the future. This is an important practice and innovation in the regulatory science of the NMPA, which has a significant meaning of reform.