Something that is underappreciated is China has 4x the population and Tier 1 cities are 30 million people, so easier to recruit and finish studies.
However, their Phase 1 process is more like Australia and have more silent approval; if you don’t hear from us, proceed. Australia is fast for Phase 1 and they have more silent approval, but they are just doing safety and know the pivotal trials will primarily be done in US & other countries.
FDA tends to view Phase 1 as precedent for the entire drug program all the way through Phase 3, so they want everything to be in order from the start like CMC.
I would say Australia doesn’t really care about CMC b/c that will be covered by US during trials and scale up. For Phase 1 just need smaller batch manufacturing, do not necessarily need to be set up with standards for Phase 2 or 3 larger trials, but it makes thing smoother.