Great question Koo. I am mostly unfamiliar with the drug approval process post Phase 3 trials. What I've picked up over the past couple of years is that aside from the US following recommendations of the FDA (i.e. NDA filing/approval by FDA) and Europe folowing recommendations of the EMA (i.e. MAA filing/approval by EMA) prior to marketing/commercialization, that there are some countries outside of US and Europe that follow the recommendations of the FDA and/or EMA. However, specifically about China.....I don't know if they follow recommendations of FDA and/or EMA or if they have a separate regulatory body.

BearDownAZ