First Medical Device Approved with Real World Data
On March 26, 2020, NMPA approved Allergan, Inc.’s registration of glaucoma implant, which is the first manufacturer to gain the approval with real world data in China. In June 2019, NMPA and Hainan Provincial Government jointly ran Hainan’s clinical real-world data pilot application. The real world data are used to justify the ethnic differences between China population and overseas population. The principle of real world data is focused on patient follow up data and the sample size is very small based on overseas clinical data. Bradynuoen is helping another client following Hainan pathway to get approval. Please do not hesitate to contact us if you need any help.
