Allergan plc announced China’s National Medical Products Administration (NMPA) approved the registration of Allergan’s XEN® Gel Stent on March 26, 2020 for the surgical management of patients with refractory glaucoma. XEN® is the first product to be approved in China through the Real World Evidence pathway.
To boost the reform of China’s medical device approval process and explore the value of the Real World Evidence pathway, the NMPA and Hainan Provincial Government jointly initiated a Real World Evidence pilot program in Hainan in June 2019. Allergan partnered with the Hainan Boao Lecheng International Medical Tourism Pilot Zone and obtained permission to use XEN® in clinical practice at the Lecheng Pilot Zone in April 2019 in accordance with the policy for urgently needed imported medical devices.
When combined with data from controlled clinical trials conducted outside China, the real world evidence data collection in Hainan Province enabled the assessment of ethnic differences to treatment with XEN® and supported approval by the NMPA...
Full text GMPnews.Net