How Often Do You Expect NMPA To Require The Periodic Required Clinical Evaluations (e.g. 1x/year, 1x/5 Years)?


As discussed, this is not clarified in the current technical guidance. We believe, however, the updating frequency may be similar to that of EU CERs. This is something we are hypothesizing. Stay tuned for the upcoming final released guidance. It may contain some interpretations or clarifications on this regard.