????:1???spa500????:???????

2???????

3???????????

4?????

5??????

??????????????6??14???????????????????????? (?? ???????????)???????????14???,???,??“???????????”?

???????????????????????????,?,??«??2024???»?????????????????

???????,??????????????????????,2022??????,??????????????82????????????????????????????138??????????????,???????????20???????????????21????????????????,??????,??????????????????,???????

??????,???????????????,?????,?????????????“??????????????????????????????????”????,?????????,?????????????????,?????,??????????“?”;?,????????????????????“?????????????????????????”“????”“??????????????????????”“???????”????,????????????????????????

???????,?????,???????????????????????????????????????????????????????,??????????

?????,?????????,“2022?????3?????????????????????????????,2023???45????,2024????24?”????????????,???,??

??,??,??2017?6??(ICH)????,??????68???ICH????,???????????????????,????????????

??????,???????????????,???“????”,??(??????) ?????????????????:???????