Ann: First Patient Safely Combine Dosed in Phase 1 RC220 Trial, page-123

  1. 204 Posts.
    lightbulb Created with Sketch. 814
    https://hotcopper.com.au/data/attachments/7120/7120037-1b5cd036d111562a77b400bab3bc347b.jpg

    https://hotcopper.com.au/data/attachments/7120/7120040-dbfa441f04bbea1c4accb65caa474407.jpg
    https://novotech-cro.com/news/novotech-update-china-implements-5-key-changes-accelerate-clinical-trial-and-drug-approval

    https://hotcopper.com.au/data/attachments/7120/7120042-00dc3fde0bd93edf5eb23e302c8b7650.jpg
    https://hotcopper.com.au/data/attachments/7120/7120044-6653959661dcac10fdb04b23290c3588.jpg
    https://www.pacificbridgemedical.com/uncategorized/understanding-chinas-drug-registration-process/

    I'm sure RAC have received adequate counsel from regulatory specialists in this part of the world. I'd argue that patients in HK of ethnic Chinese descent would satisfy the Chinese regulatory bodies' requirements for ethnically diverse data.

    Its clear that RAC is trying to minimise the time to market in Asia - you just have to ask yourself why?
    Last edited by JBeez_: 10/07/25
 
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