Kutshanje, iZiko loVavanyo lweZiyobisi (CDE) loRhulumente woKutya kunye noLawulo lweDrugs likhuphe isaziso kwi "Technical Guidelines for Pharmaceutical Changes in Marketed Biological Products (Trial)". Izikhokelo ziya kuphunyezwa ukususela ngomhla wokukhutshwa (ngoJuni 25, 2021). Iqulethe izahluko ze-9 ezibandakanya umboniso, imigaqo esisiseko, iimfuno ezisisiseko, utshintsho lwenkqubo yokuvelisa, utshintsho lwabaxhamli ekuqulunqweni, utshintsho lwenkcazo okanye ukupakisha ukupakisha, utshintsho lwemigangatho yokubhalisa, ukutshintshwa kwezinto zokupakisha kunye nezikhongozeli, utshintsho lwexesha elisemthethweni okanye iimeko zokugcina. Imigaqo yesikhokhelo isebenza kwiimveliso zothintelo lwebhayoloji, iimveliso zonyango lwebhayoloji, kunye ne-in vitro diagnostic reagents ezilawulwa ziimveliso zebhayoloji, kwaye icacisa izimvo ezisisiseko kunye neenkxalabo zophando malunga notshintsho kubhaliso kunye nolawulo lweemveliso zebhayoloji emva kwemarike.