為(wei)規范(fan)和指(zhi)(zhi)導中藥注(zhu)(zhu)射(she)劑(ji)(ji)安全性(xing)(xing)再(zai)(zai)評(ping)(ping)價(jia)工作,國家食(shi)品藥品監督管(guan)理(li)局組織制(zhi)(zhi)定了中藥注(zhu)(zhu)射(she)劑(ji)(ji)安全性(xing)(xing)再(zai)(zai)評(ping)(ping)價(jia)生產工藝評(ping)(ping)價(jia)技(ji)術(shu)原(yuan)(yuan)(yuan)則(ze)(試(shi)(shi)行(xing)(xing))、中藥注(zhu)(zhu)射(she)劑(ji)(ji)安全性(xing)(xing)再(zai)(zai)評(ping)(ping)價(jia)質量控制(zhi)(zhi)評(ping)(ping)價(jia)技(ji)術(shu)原(yuan)(yuan)(yuan)則(ze)(試(shi)(shi)行(xing)(xing))、中藥注(zhu)(zhu)射(she)劑(ji)(ji)安全性(xing)(xing)再(zai)(zai)評(ping)(ping)價(jia)非臨床研究評(ping)(ping)價(jia)技(ji)術(shu)原(yuan)(yuan)(yuan)則(ze)(試(shi)(shi)行(xing)(xing))、中藥注(zhu)(zhu)射(she)劑(ji)(ji)安全性(xing)(xing)再(zai)(zai)評(ping)(ping)價(jia)臨床研究評(ping)(ping)價(jia)技(ji)術(shu)原(yuan)(yuan)(yuan)則(ze)(試(shi)(shi)行(xing)(xing))、企業對中藥注(zhu)(zhu)射(she)劑(ji)(ji)風險控制(zhi)(zhi)能(neng)力評(ping)(ping)價(jia)技(ji)術(shu)原(yuan)(yuan)(yuan)則(ze)(試(shi)(shi)行(xing)(xing))、中藥注(zhu)(zhu)射(she)劑(ji)(ji)安全性(xing)(xing)再(zai)(zai)評(ping)(ping)價(jia)風險效益(yi)評(ping)(ping)價(jia)技(ji)術(shu)原(yuan)(yuan)(yuan)則(ze)(試(shi)(shi)行(xing)(xing))、中藥注(zhu)(zhu)射(she)劑(ji)(ji)風險管(guan)理(li)計劃指(zhi)(zhi)導原(yuan)(yuan)(yuan)則(ze)(試(shi)(shi)行(xing)(xing))7個技(ji)術(shu)原(yuan)(yuan)(yuan)則(ze),并于日(ri)前印(yin)發(fa)。 |