中藥管理戰略決策專委會成立
來源:廣州日報 作者:涂端玉 時間:2022-7-5 閱讀:
近日,國(guo)(guo)家(jia)(jia)(jia)藥(yao)(yao)(yao)品(pin)監(jian)督(du)管(guan)(guan)理(li)(li)局發布《關(guan)于成(cheng)立(li)(li)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)管(guan)(guan)理(li)(li)戰(zhan)略決(jue)(jue)策(ce)專(zhuan)(zhuan)家(jia)(jia)(jia)咨(zi)詢委(wei)(wei)員(yuan)會(hui)的(de)通(tong)知》。為進(jin)一(yi)步構(gou)建完(wan)(wan)善符合中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)特(te)點的(de)審評審批(pi)體(ti)系(xi),保障和促進(jin)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)監(jian)管(guan)(guan)工作(zuo)重大(da)決(jue)(jue)策(ce)的(de)科(ke)(ke)學性(xing)、權威性(xing),依據(ju)《藥(yao)(yao)(yao)品(pin)注冊管(guan)(guan)理(li)(li)辦法》有(you)關(guan)規(gui)定(ding),國(guo)(guo)家(jia)(jia)(jia)藥(yao)(yao)(yao)監(jian)局成(cheng)立(li)(li)由兩院(yuan)(yuan)院(yuan)(yuan)士(shi)、國(guo)(guo)醫大(da)師、資深(shen)專(zhuan)(zhuan)家(jia)(jia)(jia)組(zu)成(cheng)的(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)管(guan)(guan)理(li)(li)戰(zhan)略決(jue)(jue)策(ce)專(zhuan)(zhuan)家(jia)(jia)(jia)咨(zi)詢委(wei)(wei)員(yuan)會(hui)。專(zhuan)(zhuan)委(wei)(wei)會(hui)共由40名人(ren)(ren)員(yuan)組(zu)成(cheng),其中(zhong)(zhong)(zhong)中(zhong)(zhong)(zhong)國(guo)(guo)科(ke)(ke)學院(yuan)(yuan)院(yuan)(yuan)士(shi)2人(ren)(ren)、中(zhong)(zhong)(zhong)國(guo)(guo)工程院(yuan)(yuan)院(yuan)(yuan)士(shi)16人(ren)(ren)、國(guo)(guo)醫大(da)師3人(ren)(ren)、資深(shen)專(zhuan)(zhuan)家(jia)(jia)(jia)19人(ren)(ren)。中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)管(guan)(guan)理(li)(li)戰(zhan)略決(jue)(jue)策(ce)專(zhuan)(zhuan)家(jia)(jia)(jia)咨(zi)詢委(wei)(wei)員(yuan)會(hui)成(cheng)立(li)(li),旨在進(jin)一(yi)步構(gou)建完(wan)(wan)善中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)特(te)點的(de)審評審批(pi)體(ti)系(xi),保障和促進(jin)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)監(jian)管(guan)(guan)工作(zuo)重大(da)決(jue)(jue)策(ce)的(de)科(ke)(ke)學性(xing)、權威性(xing)。
有機構預測,未來五年(nian),中國中醫(yi)藥(yao)(yao)行業(ye)市場(chang)規模(mo)將(jiang)保持約14.2%的年(nian)復(fu)合增(zeng)(zeng)長(chang)(chang)率高(gao)速增(zeng)(zeng)長(chang)(chang)。到2025年(nian),市場(chang)規模(mo)將(jiang)有望達到48071.7億元。中藥(yao)(yao)創新(xin)藥(yao)(yao)審(shen)批正在不斷提速。近期發布的《2021年(nian)度藥(yao)(yao)品(pin)審(shen)評(ping)報告》顯示,2021年(nian),國家藥(yao)(yao)品(pin)監督管理(li)(li)局(ju)藥(yao)(yao)品(pin)審(shen)評(ping)中心受理(li)(li)中藥(yao)(yao)注冊申請444件(jian),同(tong)比(bi)(bi)增(zeng)(zeng)長(chang)(chang)40.95%。以注冊申請類別(bie)統計(ji),受理(li)(li)新(xin)藥(yao)(yao)臨床試驗申請52件(jian),同(tong)比(bi)(bi)增(zeng)(zeng)長(chang)(chang)136.36%,包括創新(xin)中藥(yao)(yao)44件(jian)(43個品(pin)種),同(tong)比(bi)(bi)增(zeng)(zeng)長(chang)(chang)158.82%;新(xin)藥(yao)(yao)上(shang)市許(xu)可申請14件(jian),同(tong)比(bi)(bi)增(zeng)(zeng)長(chang)(chang)133.33%。
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