2023-08-28 15:35:34
市場監管總局近日發布《保(bao)(bao)健(jian)食(shi)品(pin)新功(gong)(gong)能(neng)(neng)及產品(pin)技術(shu)評(ping)(ping)(ping)價(jia)(jia)實(shi)施細(xi)則(試行)》。對以(yi)往保(bao)(bao)健(jian)食(shi)品(pin)功(gong)(gong)能(neng)(neng)聲稱(cheng)評(ping)(ping)(ping)價(jia)(jia)管理模式(shi)進行了(le)創新。根據細(xi)則,新功(gong)(gong)能(neng)(neng)產品(pin)實(shi)行上(shang)市前(qian)(qian)審評(ping)(ping)(ping)和上(shang)市后評(ping)(ping)(ping)價(jia)(jia)相(xiang)結合(he),新功(gong)(gong)能(neng)(neng)評(ping)(ping)(ping)價(jia)(jia)方(fang)法原則上(shang)必(bi)須包(bao)括人(ren)體試食(shi)試驗(yan)。評(ping)(ping)(ping)價(jia)(jia)指標及判定(ding)標準應科學、明確、可(ke)行,并經(jing)過(guo)驗(yan)證評(ping)(ping)(ping)價(jia)(jia)。同時,驗(yan)證評(ping)(ping)(ping)價(jia)(jia)應當(dang)充分評(ping)(ping)(ping)估實(shi)驗(yan)室(shi)間(jian)差(cha)異(yi),在提(ti)(ti)出新功(gong)(gong)能(neng)(neng)建(jian)議前(qian)(qian),應當(dang)通過(guo)符(fu)合(he)要(yao)求的至(zhi)(zhi)少一家食(shi)品(pin)檢(jian)驗(yan)機(ji)構(gou)或臨床試驗(yan)機(ji)構(gou)驗(yan)證評(ping)(ping)(ping)價(jia)(jia);同步提(ti)(ti)出新功(gong)(gong)能(neng)(neng)保(bao)(bao)健(jian)食(shi)品(pin)注(zhu)冊的,在上(shang)市后評(ping)(ping)(ping)價(jia)(jia)期(qi)間(jian),應當(dang)通過(guo)符(fu)合(he)要(yao)求的至(zhi)(zhi)少兩家食(shi)品(pin)檢(jian)驗(yan)機(ji)構(gou)或臨床試驗(yan)機(ji)構(gou)驗(yan)證評(ping)(ping)(ping)價(jia)(jia)。
在探索開展(zhan)新(xin)(xin)(xin)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)保(bao)健(jian)(jian)食品(pin)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng)分(fen)(fen)(fen)級(ji)動態管理(li)方面(mian),實(shi)行(xing)保(bao)健(jian)(jian)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)分(fen)(fen)(fen)類評價(jia)、分(fen)(fen)(fen)級(ji)標注。如(ru)(ru)果(guo)(guo)把“科(ke)學(xue)證(zheng)據(非(fei)結論性(xing)證(zheng)據)表明該(gai)產(chan)品(pin)具(ju)有***功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)”通俗表述(shu)為(wei)A級(ji)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng),那么“支持性(xing)研究證(zheng)據(非(fei)結論性(xing)證(zheng)據)表明該(gai)產(chan)品(pin)具(ju)有***功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)”則為(wei)B級(ji)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng),“有限(xian)的研究證(zheng)據(非(fei)結論性(xing)證(zheng)據)表明該(gai)產(chan)品(pin)具(ju)有***功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)”則為(wei)C級(ji)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng)。該(gai)條款(kuan)對經營主體最大的吸引力(li)在于,新(xin)(xin)(xin)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)保(bao)健(jian)(jian)食品(pin)上市后(hou)評價(jia)后(hou),依(yi)(yi)據科(ke)學(xue)共識充足程度對保(bao)健(jian)(jian)食品(pin)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng)實(shi)行(xing)動態管理(li),可依(yi)(yi)據評價(jia)結果(guo)(guo)調整保(bao)健(jian)(jian)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng)限(xian)定(ding)用語(yu),用科(ke)學(xue)監管理(li)念促進產(chan)業高質量發展(zhan)。也(ye)就是說,某款(kuan)新(xin)(xin)(xin)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)保(bao)健(jian)(jian)食品(pin)如(ru)(ru)果(guo)(guo)上市后(hou)評價(jia)良好,C級(ji)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng)也(ye)可以調整為(wei)B級(ji)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng),甚至A級(ji)功(gong)(gong)(gong)(gong)(gong)能(neng)(neng)聲(sheng)(sheng)(sheng)稱(cheng)(cheng)(cheng)。(央視新(xin)(xin)(xin)聞)
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