If such an "endorsement" does not exist, the CDE will examine the effectiveness, risks, ethics and other factors of human trials, expending much time in the process.
若未事先拿到此一「背書」，醫藥品查驗中心將會對新藥人體實驗的風險性、有效性、道德性等條件逐一審核，曠日廢時。