大清点!省级中药配方颗粒办理方法接踵出台,偏重点各有哪些?
2月(yue)1日,国(guo)度药(yao)监(jian)局(ju)、国(guo)度西(xi)医药(yao)局(ju)、国(guo)度卫生安康委、国(guo)度医保(bao)局(ju)配(pei)合(he)宣布《对(dui)(dui)于竣(jun)事中(zhong)药(yao)配(pei)方(fan𝔍g)颗粒(li)试点任(ren)务的告(gao)诉(su)(su)布告(gao)》,决议竣(jun)事中(zhong)药(yao)配(pei)方(fang)颗粒(li)试点任(ren)务,对(dui)(dui)配(pei)方(fang)颗粒(li)种类实行(xing)备案办理,其品质羁系(xi)归入中(zhong)药(yao)饮(yin)片办理规模。《告(gao)诉(su)(su)布告(gao)》对(dui)(dui)配(pei)方(fang)颗粒(li)出(chu)产、运营、利用(yong)各关(guan)键作出(chu)规范。随后(hou),各省(区、市)在《告(gao)诉(su)(su)布告(gao)》请求的根本上连(lian)续出(chu)台了省级(ji)中(zhong)药(yao)配(pei)方(fang)颗粒(li)办理方(fang)法及(ji)相干文件,停(ting)止11月(yue)3日,已有26个省(区、市)宣布相干告(gao)诉(su)(su)布告(gao)。
北京。10月(yue)29日(ri),北(bei)(bei)京(jing)(jing)(jing)(jing)市(shi)(shi)药(yao)监(jian)局(ju)、北(bei)(bei)京(jing)(jing)(jing)(jing)市(shi)(shi)西(xi)医(yi)办(ban)理(li)局(ju)、北(bei)(bei)京(jing)(jing)(jing)(jing)市(shi)(shi)卫🧸(wei)生安(an)康委员会、北(bei)(bei)京(jing)(jing)(jing)(jing)市(shi)(shi)医(yi)疗保证(zheng)局(ju)结合宣(xuan)布《北(bei)(bei)京(jing)(jing)(jing)(jing)市(shi)(shi)中(zhong)药(yao)配方(fang)(fang)(fang)颗(ke)粒(li)办(ban)理(li)实行(xing)(xing)细则(ze)(试行(xing)(xing))》。《实行(xing)(xing)细则(ze)》共(gong)七章(zhang)42条,从出产办(ban)理(li)、备案办(ban)理(li)、畅通利用办(ban)理(li)、医(yi)保办(ban)理(li)、监(jian)视(shi)办(ban)理(li)五个(ge)(ge)方(fang)(fang)(fang)面临中(zhong)药(yao)配方(fang)(fang)(fang)颗(ke)粒(li)的办(ban)理(li)停止(zhi)了规范,已(yi)于(yu)(yu)11月(yue)1日(ri)实行(xing)(xing)。另外,北(bei)(bei)京(jing)(jing)(jing)(jing)市(shi)(shi)药(yao)监(jian)局(ju)还宣(xuan)布了《北(bei)(bei)京(jing)(jing)(jing)(jing)市(shi)(shi)中(zhong)药(yao)配方(fang)(fang)(fang)颗(ke)粒(li)规范》,此中(zhong)第(di)一(yi)批121此中(zhong)药(yao)配方(fang)(fang)(fang)颗(ke)粒(li)规范已(yi)于(yu)(yu)11月(yue)1日(ri)实行(xing)(xing),残剩116个(ge)(ge)种类规范在公然收罗(luo)定见(jian)。
河北。10月(yue)15日(ri),河(he)(he)(he)(he)北(bei)(bei)省药监(jian)(jian)局、河(he)(he)(he)(he)北(bei)(bei)省西医(yi)药办理(li)局、河(he)(he)(he)(he)北(bei)(bei)省卫生安康委员会(hui)、河(he)(he)(he)(he)北(bei)(bei)省医(yi)疗(liao)保证局结合宣布《河(he)(he)(he)(he)北(bei)(bei)省中(zhong)药配方(fang)颗(ke)粒(li)办理(li)实(shi)行(xing)(xing)细(xi)则(试行(xing)(xing))》。《实(shi)行(xing)(xing)细(xi)则》共五(wu)章24条,从出产办理(li)、利(li)用(yong)办理(li)、药品(pin)规(gui)范、备案和监(jian)(jian)视办理(li)四个方(fang)面临中(zhong)药配方(fang)颗(ke)粒(li)办理(li)停止了规(gui)范,已于ဣ(yu)11月(yue)1日(ri)实(shi)行(xing)(xing)。另(ling)外,河(he)(he)(he)(he)北(bei)(bei)省药监(jian)(jian)局还印发了《河(he𒈔)(he)(he)(he)北(bei)(bei)省中(zhong)药配方(fang)颗(ke)粒(li)品(pin)质规(gui)范》,此中(zhong)第一批203此中(zhong)药配方(fang)颗(ke)粒(li)品(pin)质规(gui)范已于(yu)11月(yue)1日(ri)实(shi)行(xing)(xing)。
吉林。10月29日(ri),吉(ji)林(lin)省药(yao)监局(ju)、吉(ji)林(lin)省西医药(yao)办(ban)(ban)(ban)理(li)(li)(li)局(ju)、吉(ji)林(lin)省卫(wei)生安康委员会、吉(ji)林(lin)省医疗保证局(ju)结合印发《吉(ji)林(lin)省中(zhong)(zhong)药(yao)配方颗粒办(ban)(ban)(ban)理(li)(li)(li)实行细则(ze)(试(shi)行)》。《实行细则(ze)》共七章40条,从规(gui)范(fan)办(ban)(ban)(ban)理(li)(li)(li)、种类备(bei)案办(ban)(ban)(ban)理(li)(li)(li)、出产(chan)办(ban)(ban)(ban)理(li)(li)(li)、畅(chang)通与利用办(ban)(ban)(ban)理(li)(li)(li)、监视办(ban)(ban)(ban)理(li)(li)(li)五(wu)个方面临中(zhong)(zhong)药(yao)配方颗粒办(ban)(ban)(ban)理(li)(li)(li)停止了规(gui)范(fan)。另(ling)外,吉(ji)林(lin)省药(yao)监局(ju)还印发了《吉(ji)林(lin)省中(zhong)(zhong)药(yao)配🐼方颗粒规(gui)范(fan)》,第一(yi)批18个种类正在(zai)停止公示。
黑龙江。11月1日,黑(hei)(hei)龙(long)(long)江(jiang)(jiang)省(sheng)药(yao)监(jian)局(ju)、黑(hei)(hei)龙(long)(long)江(jiang)(jiang)省(sheng)西医药(yao)办理(li)局(ju)、黑(hei)(hei)龙(long)(long)江(jiang)(jiang)省(sheng)卫生安康委员会、黑(hei)(hei)龙(long)(long)江(jiang)(jiang)省(sheng)医疗(liao)保证局(ju)结合印发《黑(hei)(hei)龙(long)(long)江(jiang)(jiang)省(sheng)中药(yao)配方(fang)颗(ke)粒(li)办理(li)实行(xing)(xing)细则(ze)(试行(xing)(xing)),《实行(xing)(xing)细则(ze)》共23条,明白了(le)各部(bu)分的(de)协作,对(dui)主要配方(fang)颗(ke)粒(li)的(de)备案办理(li)、出产办理(li)、配送和利用办理(li)、监(jian)视(shi)办理(li)提(ti)出了(le)请求。另外(wai),黑(hei)(hei)龙(long)(long)江(jiang)(jiang)省(sheng)药(yao)监(jian)局(ju)还印发了(le)《黑(hei)(hei)龙(long)(long)江(jiang)(j🔯iang)省(sheng)中药(yao)配方(fang)颗(ke)粒(li)规范》,今朝(chao)3批(pi)174个种(zhong)类(lei)正在(zai)公示。
江苏。9月30日(ri),江(jiang)(jiang)苏(su)省(sheng)(sheng)药(yao)监(jian)(jian)局(ju)、江(jiang)(jiang)苏(su)省(sheng)(sheng)卫生安康委员会、江(jiang)(jiang)苏(su)省(sheng)(sheng)西医药(yao)办理(li)局(ju)、江(jiang)(jiang)苏(su)省(sheng)(sheng)医疗保证(zheng)局(ju)结合印发(fa)《江(jiang)(jiang)苏(su)省(sheng)(sheng)中(zhong)(zhong)药(yao)配(pei)方颗粒办理(li)细则(ze)》。《办理(li)细则(ze)》共(gong)七(qi)章42条,从备案办理(li)、规范办理(li)、出产办理(li)、利用办理(li)、监(jian)(jian)视办理(li)五个方面临中(zhong)(zhong)药(yao)配(pei)方颗粒办理(li)停止了规范。另(ling)外,江(jiang)(jiang)苏(su)省(sheng)(sheng)药(yao)监(jian)(jian)局(ju)还拟定了《江(jiang)(jiang)苏(su)省(sheng)(sheng)中(zhong)(zhong)药(yaoꦿ)配(pei)方颗粒规范》,今朝第一批45个种类(lei)规范已于11月1日(ri)实行,另(ling)有4批119个种类(lei)正在(zai)公示。
浙江。10月(yue)27日(ri),浙(zhe)江(jiang)(jiang)省药(yao)(yao)(yao)监局(ju)、浙(zhe)江(jiang)(jiang)省西医(yi)药(yao)(yao)(yao)办(ban)理(li)(li)(li)局(ju)、浙(zhe)江(jiang)(jiang)省卫生(sheng)安康委(wei)员会、浙(zhe)江(jia🌠ng)(jiang)省医(yi)疗(liao)保(bao)证局(ju)结(jie)合(he)印发《浙(zhe)江(jiang)(jiang)省中(zhong)药🐓(yao)(yao)(yao)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)办(ban)理(li)(li)(li)细(xi)则(ze)(ze)》。《办(ban)理(li)(li)(li)细(xi)则(ze)(ze)》共九章42条,从(cong)出(chu)产企业和中(zhong)药(yao)(yao)(yao)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)种类根基请求、中(zhong)药(yao)(yao)(yao)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)备案、中(zhong)药(yao)(yao)(yao)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)出(chu)产等九方(fang)面临中(zhong)药(yao)(yao)(yao)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)办(ban)理(li)(li)(li)停止(zhi)了规(gui)(gui)(gui)范(fan)。值(zhi)得一提(ti)的是,《办(ban)理(li)(li)(li)细(xi)则(ze)(ze)》出(chu)格夸大了中(zhong)药(yao)(yao)(yao)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)医(yi)保(bao)付出(chu)规(gui)(gui)(gui)范(fan),综合(he)斟酌多(duo)种身分(fen)(fen)将中(zhong)药(yao)(yao)(yao)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)分(fen)(fen)批归入(ru)医(yi)保(bao)付出(chu)规(gui)(gui)(gui)模(mo),并参照乙类办(ban)理(li)(li)(li),小我先行自付比例3%。另外,浙(zhe)江(jiang)(jiang)省药(yao)(yao)(yao)监局(ju)还拟定了《浙(zhe)江(jiang)(jiang)省中(zhong)药(yao)(yao)(yao)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)规(gui)(gui)(gui)范(fan)》,今朝10个(ge)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)品(pin)质规(gui)(gui)(gui)范(fan)已于11月(yue)1日(ri)实行,另有18个(ge)配(pei)(pei)(pei)方(fang)颗(ke)(ke)粒(li)(li)(li)品(pin)质规(gui)(gui)(gui)范(fan)正(zheng)在(zai)停止(zhi)公(gong)示。
安徽。10月27日,安(an)(an)徽省药(yao)(yao)监局(ju)(ju)、安(an)(an)徽省卫生安(an)(an)康委(wei)、安(an)(an)徽省西医药(yao)(yao)局(ju)(ju)、安(an)(an)徽省科技厅(ting)、安(an)(an)徽省经济与信(xin)息化厅(ting)6部分结合印发《安(an)(an)徽省中(zhong)药(yao)(yao)配(pei)方(fang)(fang)(fang)颗(ke)粒(li)办理(li)方(fang)(fang)(fang)法(试行(xing))》。《办理(li)方(fang)(fang)(fang)法》共30条(tiao),对中(zhong)药(yao)(yao)配(pei)方(fang)(fang)(fang)颗(ke)粒(li)备案、出产、配(pei)送、利用(yong)、医保付(fu)出和监视(shi)办理(li)等(deng)停(ting)止(zhi)了规范(fan)。《办理(li)方(fang)(fang)(fang)法》出格(ge)夸大了科技和经信(xin)部分要将中(zhong)药(yao)(yao)配(pei)方(fang)(fang)(fang)颗(ke)粒(li)财产归入科技成(cheng)长计划和经济成(cheng)长计划。另外,安(an)(an)徽省药(yao)(yao)监局(ju)(ju)还(hai)拟(ni)定(ding)了《安(an)(an)徽省中(zhong)药(yao)(yao)配(pei)方(fang)(fang)(fang)颗(ke)粒(li)规范(fan)》,今(jin)朝已宣(xuan)布2批(pi)93个(ge)省级中(zhong)药(yao)(yao)配(pei)方(fang)(fang)(fang)颗(ke)🐠粒(li)规范(fan),另有100个(ge)种类在停(ting)止(zhi)公示(shi)。
江西。10月29日,江(jiang)西省(sheng)药(yao)监局(ju)、江(jiang)西省(sheng)卫生安康委员会、江(jiang)西省(sheng)西医(yi)药(yao)办(ban)(ban)(ban)(ban)理局(ju)、江(jiang)西省(sheng)医(yi)疗保证局(ju)、江(jiang)西省(sheng)迷信手艺(yi)厅、江(jiang)西省(sheng)产业(ye)和信息化厅6部(bu)分结合印发《江(jiang)西省(sheng)中(zhong)药(yao)配(pei)方(fang)颗(ke)粒(li)(li)办(ban)(ban)(ban)(ban)理细则(试行(xing))》。《办(ban)(ban)(ban)(ban)理细🐷则》共(gong)七章47条(tiao),从规(gui)(gui)(gui)范办(ban)(ban)(ban)(ban)理、备案办(ban)(ban)(ban)(ban)理、出产办(ban)(ban)(ban)(ban)理、发卖利用办(ban)(ban)(ban)(ban)理五个方(fang)面临中(zh💫ong)药(yao)配(pei)方(fang)颗(ke)粒(li)(li)办(ban)(ban)(ban)(ban)理停(ting)止了规(gui)(gui)(gui)范。《办(ban)(ban)(ban)(ban)理细则》出格夸大(da)将(jiang)中(zhong)药(yao)配(pei)方(fang)颗(ke)粒(li)(li)归入经济成(cheng)长计划(hua),鼓(gu)动勉励(li)企业(ye),高档院校、科研(yan)院所等展(zhan)开相干手艺(yi)和规(gui)(gui)(gui)范研(yan)讨。另外,江(jiang)西省(sheng)药(yao)监局(ju)还拟定(ding)了《江(jiang)西省(sheng)中(zhong)药(yao)配(pei)方(fang)颗(ke)粒(li)(li)规(gui)(gui)(gui)范》,已(yi)宣布2批(pi)共(gong)100个省(sheng)级(ji)(ji)中(zhong)药(yao)配(pei)方(fang)颗(ke)粒(li)(li)规(gui)(gui)(gui)范,另有(you)149个省(sheng)级(ji)(ji)中(zhong)药(yao)配(pei)方(fang)颗(ke)粒(li)(li)规(gui)(gui)(gui)范在停(ting)止公示。
山东。10月(yue)27日(ri),山东(dong)(dong)省(sheng)药监局、山东(dong)(dong)省(sheng)卫健委(wei)、山东(dong)(dong)省(sheng)医(yi)保局结(jie)合(he)宣(xuan)布(bu)《山东(dong)(dong)省(sheng)中(zhong)药配(pei)(pei)(pei)方(fang)(fang)颗粒(li)办(ban)理(li)细(xi)则》。《办(ban)理(li)细(xi)则》共七章49条,触及(ji)中(zhong)药配(pei)(pei)(pei)方(fang)(fang)颗粒(li)规范(fan)办(ban)理(li)、出产办(ban)理(li)、备案(an)办(ban)理(li)、利🥀用办(ban)理(li)、监视(shi)办(ban)理(li)等外(wai)容(rong)。《办(ban)理(li)细(xi)则》已于11月(yue)1日(ri)起实行,《办(ban)理(li)细(xi)则》出格列了然(ran)山东(dong)(dong)省(sheng)规范(fan)请(qing)求相(xiangꦕ)干法(fa)式及(ji)报告材(cai)料请(qing)求。另(ling)外(wai),山东(dong)(dong)省(sheng)药监局还拟定了《山东(dong)(dong)省(sheng)中(zhong)药配(pei)(pei)(pei)方(fang)(fang)颗粒(li)规范(fan)》,今朝已宣(xuan)布(bu)2批共159个省(sheng)级(ji)中(zhong)药配(pei)(pei)(pei)方(fang)(fang)颗粒(li)规范(fan)。
湖南。5月(yue)19日(ri),湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)药监局(ju)印发《湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)中(zhong)药配(pei)方(fang)(fang)颗(ke)粒(li)备案报(bao)告任(ren)务流(liu)程(试行)》和(he)《湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)中(zhong)药配(pei)方(fang)(fang)颗(ke)粒(li)品(pin)质节制与(yu)规范(fan)拟(ni)定(ding)手艺请求(qiu)(试行)》。10月(yue)11日(ri),湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)药监局(ju)、湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)西医(yi)药办(ban)理(li)(li)(li)局(ju)、湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)卫生安康委员会、湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)医(yi)疗保证局(ju)结合印发《增强湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)中(zhong)药配(pei)方(fang)(fang)颗(ke)粒(li)办(ban)理(li)(li)(li)的实(shi)行定(ding)见》,《实(shi)行定(ding)见》触(chu)及出(chu)产办(ban)理(li)(li)(li)、医(yi)保付出(chu)、发卖(mai)办(ban)理(li)(li)(li)、监视办(ban)理(li)(li)(li)等外(wai)容。另外(wai),湖(hu)(hu)(hu)南(nan)省(sheng)(sheng)药监局(ju)还拟(ni)定(ding)了(le)《湖(hu)(hu)(hu)南(nan)省(sheng)(she𝄹ng)中(zhong)药配(pei)方(fang)(fang)颗(ke)粒(li)规范(fan)》,今朝第(di)一批28此(ci)中(zhong)药配(pei)方(fang)(fang)颗(ke)粒(li)规范(fan)已宣布,另有26此(ci)中(zhong)药配(pei)方(fang)(fang)颗(ke)粒(li)规范(fan)正在公示。
广东。11月1日,广东(dong)省(sheng)(sheng)药(yao)监局、广东(dong)省(sheng)(sheng)西医药(yao)局、广东(dong)省(sheng)(sheng)卫生安康委员会、广东(dong)省(sheng)(sheng)医疗(liao)保证局结合印发《广东(dong)省(sheng)(sheng)中药(yao)配(pei)方(fang)颗(ke)粒办理细(xi)则》。《办理细(xi)则》共七章(zhang)48条,触及(ji)备(bei)案办理、规(gui)范办理、出产办理、利用办理、监视办理等外容。《办理细(xi)则》出格(ge)对出产💧企(qi)业异地车(c🐓he)间(jian)和共用车(che)间(jian)办理提出了请求(qiu)。
海南。7月21日,海(hai)(hai)南(nan)(nan)省药(yao)(yao)监局(ju)(ju)、海(hai)(hai)南(nan)(nan)省西医(yi)药(yao)(yao)办理(li)局(ju)(ju)、海(hai)(hai)南(nan)(💫nan)省卫生安康(kang)委员会、海(hai)(hai)南(nan)(nan)省医(yi)疗保(bao)证局(ju)(ju)四部分结合印发(fa)《海(hai)(hai)南(nan)(nan)省中(zhong)(zhong)(zhong)药(yao)(yao)配方颗(ke)(ke)粒(li)办理(li)实(shi)行细则(试(shi)行)》。《实(shi)行细则》共20条,触及(ji)中(zhong)(zhong)(zhong)药(yao)(yao)配方颗(ke)(ke)粒(li)的出产、配送、利用、医(yi)保(bao)付出和监视办理(li)等外(wai)容。《实(shi)行细则》出格夸大了(le)鼓动勉励民营(ying)医(yi)疗机构(gou)参与中(zhong)(zhong)(zhong)药(yao)(yao)配方颗(ke)(ke)粒(li)挂网推销。另外(wai),海(hai)(hai)南(nan)(nan)省药(yao)(yao)监局(ju)(ju)还拟定了(le)《海(hai)(hai)南(nan)(nan)省中(zhong)(zhong)(zhong)药(yao)(yao)配方颗(ke)(ke)粒(li)品(pin)质(zhi)规范》,第(di)一批223此中(zhong)(zhong)(zhong)药(yao)(yao)配方颗(ke)(ke)粒(li)品(pin)质(zhi)规范已宣布。
重庆。10月27日,重(zhong)(zhong)庆市(shi)药监局、重(zhong)(🤪zhong)庆市(shi)卫生安康委员(yuan)会、重(zhong)(zhong)庆市(shi)西医办(ban)(ban)理(li)(li)局、重(zhong)(zhong)庆市(shi)医疗保证(zheng)局四部(bu)分结合印发《重(zhong)(zhong)庆市(shi)中(zhong)(zhong)药配方颗粒办(ban)(ban)理(li)(li)实(shi)行细则(ze)(试行)》。《实(shi)行细则(ze)》共七章32条,触及中(zhong)(zhong)药配方颗粒的(de)备案办(ban)(ban)理(li)(li)、备案办(ban)(ban)理(li)(li)、规范(fan)办(ban)(ban)理(li)(li)、畅通利(li)用办(ban)(ban)理(li)(li)、监视办(ban)(ban)理(li)(li)等(deng)外容。
四川。10月9日,四(si)川(chuan)(chuan)省(sheng)(sheng)(sheng)(sheng)药(yao)(yao)监局(ju)、四(si)川(chuan)(chuan)省(sheng)(sheng)(sheng)(sheng)卫生(sheng)安康委员会、四(si)川(chuan)(chuan)省(sheng)(sheng)(sheng)(sheng)医(yi)疗(liao)保证局(ju)、四(si)川(chuan)(chuan)省(sheng)(sheng)(sheng)(sheng)经(jing)济和信息化厅、四(si)川(chuan)(c💦huan)省(sheng)(sheng)(sheng)(sheng)西医(yi)药(yao)(yao)办理(li)局(ju)五部分结合印发《四(si)川(chuan)(🦄chuan)省(sheng)(sheng)(sheng)(sheng)中(zhong)药(yao)(yao)配(pei)方(fang)颗粒(li)(li)办理(li)实(shi)(shi)行(xing)细(xi)则》。《实(shi)(shi)行(xing)细(xi)则》共六章(zhang)40条,包罗备案办理(li)、出产办理(li)、畅通利用办理(li)、监视办理(li)等外容。《实(shi)(shi)行(xing)细(xi)则》出格(ge)夸大(da)了中(zhong)药(yao)(yao)配(pei)方(fang)颗粒(li)(li)跨(kua)省(sheng)(sheng)(sheng)(sheng)备案的(de)相干(gan)请求。另外,四(si)川(chuan)(chuan)省(sheng)(sheng)(sheng)(sheng)药(yao)(yao)监局(ju)还(hai)拟定了《四(si)川(chuan)(chuan)省(sheng)(sheng)(sheng)(sheng)中(zhong)药(yao)(yao)配(pei)方(fang)颗粒(li)(li)规(gui)范》,今朝112此中(zhong)药(yao)(yao)配(pei)方(fang)颗粒(li)(li)品质规(gui)范已宣布(bu)。
贵州。10月29日,贵(gui)ꦍ(gui)(gui)州(zhou)省(sheng)(sheng)药(yao)监(jian)局、贵(gui)(gui)(gui)州(zhou)省(sheng)(sheng)卫生(sheng)安康(kang)委员会、贵(gui)(gui)(gui)州(zhou)省(sheng)(sheng)西医(yi)药(yao)办(ban)(ban)(ban)(ban)理局、贵(gui)(gui)(gui)州(zhou)省(sheng)(sheng)医(yi)疗保(bao)证局四(si)部分(fen)结合(he)印发《贵(gui)(gui)(gui)州(zhou)省(sheng)(sheng)中(zhong)(zhong)药(yao)配方颗(ke)粒办(ban)(ban)(ban)(ban)理细则(ze)(试行)》。《办(ban)(ban)(ban)(ban)理细则(ze)》共七(qi)章43条,触及规范办(ban)(ban)(ban)(ban)理、备案(an)办(ban)(ban)(ban)(ban)理、出产(chan)办(ban)(ban)(ban🦩)(ban)理、发卖(mai)与利用(yong)办(ban)(ban)(ban)(ban)理、监(jian)视(shi)办(ban)(ban)(ban)(ban)理等(deng)外容。另外,贵(gui)(gui)(gui)州(zhou)省(sheng)(sheng)药(yao)监(jian)局还宣布了第一批20个种类的中(zhong)(zhong)药(yao)配方颗(ke)粒品质规范。
云南。10月(yue)26日,云(yun)(yun)南(nan)省药(yao)监(jian)局(ju)(ju)、云(yun)(yun)南(nan)省产业和信(xin)息化厅、云(yun)(yun)南(nan)省卫生安(an)康(kang)委员(yuan)会、云(yun)(yun)南(nan)省医疗保证局(ju)(ju)四部(bu)分结(jie)合印发了《云(yun)(yun)南(nan)省中药(yao)配(pei)方(fang)颗粒办(ban)(ban)(ban)理(li)细则(试(shi)行)》。《办(ban)(ban)(ban)理(li)细则》共八章31条,涵盖(gai)出(chu)产企(qi)业根基请求(qiu)、规(gui)(gui)范(fan)办(ban)(ban)(ban)理(li)、备案办(ban)(ban)(ban)理(li)、出(chu)产办(ban)(ban)(ban)理(li)、发卖与利用办(ban)(ban)(ban)理(li)、监(jian)视办(ban)(ban)(ban)理(li)等外容。《办(ban)(ban)(ban)理(li)细则》出(chu)格(ge)夸大对(dui)中药(yao)配(pei)方(fang)颗粒出(chu)产企(qi)业参加年度重点羁系(xi)企(qi)业,每一年最少展开(kai)1次(ci)GMP查抄,并展开(kai)延长查抄。另(ling)外,云(yun)(yun)南(nan)省药(yao)监(jian)局(ju)(ju)还拟定了《云(yun)(yun)南(nan)省中药(yao)配(pei)方(fang)颗粒规(gui)(gui)范(fan)》,今朝已宣布第(di)1批101此(ci)中药(yao)配(pei)方(fang)🌞颗粒规(gui)(gui)范(fan)。
陕西。6月23日(ri),陕(shan)西省(sheng)(sheng)(sheng)药(yao)(yao)监局(ju)(ju)、陕(shan)西省(sheng)(sheng)(sheng)产(chan)业和信息(xi)化厅、陕(shan)西省(sheng)(sheng)(sheng)卫(wei)生安康委员会、陕(shan)西省(sheng)(sheng)(sheng)医疗保证局(ju)(ju)、陕(shan)西省(sheng)(sheng)(sheng)西医药(yao)(yao)办(ban)(ban)(ban)理(li)(li)(li)局(ju)(ju)五部分(fen)结合(he)印(yin)发(fa)《陕(shan)西省(sheng)(sheng)(sheng)中(zhong)药(yao)(yao)配方(fang)颗(ke)粒(li)办(ban)(ban)(ban)理(li)(li)(li)细则(ze)(试行(xing))》。《办(ban)(ban)(ban)理(li)(li)(li)细则(ze)》共八章27条,触及出产(chan)企业根(gen)基前提,研(yan)讨与出产(chan)办(ban)(ban)(ban)理(li)(li)(li)、备案办(ban)(ban)(ban)理(li)(li)(li)、发(fa)卖与利用、药(yao)(yao)品规范、监视办(ban)(ban)(ban)理(li)(li)(li)等(deng)外容。《办(ban)(ban)(ban)理(li)(li)(li)细则(ze)》出格明白(bai)了备案所需材料清单。另外,陕(shan)西省(sheng)(sheng)(sheng)药(yao)(yao)监局(ju)(ju)还拟(ni)定了《陕(shan)西省(sheng)(sheng)(sheng)中(zhong)药(yao)(yao)配方(fang)颗(ke)粒(li)规范》,今朝(chao)已宣🦋布第(di)一批197个种类的中(zhong)药(yao)(yao)配方(fang)颗(ke)粒(li)规范。
宁夏。10月20日,宁夏回(hui)族自(zi)治区药监局印发(fa)《宁夏回(hui)族自(zi)治区中(zꦫhong)药配方颗粒办(ban)(ban)(ban)理(li)(li)细则(ze)(试行(xing))》,《办(ban)(ban)(ban)理(li)(li)细则(ze)》共七章27条,包罗品(pin)质规(gui)范拟定、备❀(bei)案办(ban)(ban)(ban)理(li)(li)、出(chu)产办(ban)(ban)(ban)理(li)(li)、发(fa)卖(mai)与利用办(ban)(ban)(ban)理(li)(li)、监视办(ban)(ban)(ban)理(li)(li)等外容。
天津。10月(yue)25日(ri)(ri),天(tian)津(jin)市药(yao)(yao)监局(ju)印发《天(tian)⛎津(jin)市中(zhong)药(yao)(yao)配(pei)方颗(ke)粒(li)办理(li)细(xi)则(收罗定见稿)》。《收罗定见稿》对备(bei)案办理(li)、规(gui)范(fan)(fan)(fan)办理(li)、出产办理(li)、利用办理(li)和监视(shi)办理(li)五(wu)个(ge)方面提出了(le)(le)请求。另外,天(tian)津(jin)市药(yao)(yao)监局(ju)还宣布了(le)(le)新(xin)订正《天(tian)津(jin)市中(zhong)药(yao)(yao)配(pei)方颗꧃(ke)粒(li)品质(zhi)规(gui)范(fan)(fan)(fan)》,第一批(pi)182个(ge)种类规(gui)范(fan)(fan)(fan)已(yi)于11月(yue)1日(ri)(ri)实(shi)行,残剩(sheng)146个(ge)种类规(gui)范(fan)(fan)(fan)在公然收罗定见。
山西。10月8日,山(shan)西(xi)(xi)(xi)省药(yao)(yao)监局印(yin)(yin)发(fa)《山(shan)西(xi)(xi)(xi)省中药(yao)(yao)𝕴配(pei)方颗(ke)(ke)粒办(ban)(ban)(ban)理实行细则(收(shou)(shou)罗(luo)定见稿(gao))》。《收(shou)(shou)罗(luo)定见稿(gao)》共31条,从备案办(ban)(ban)(ban)理、出(chu)产(chan)办(ban)(ban)(ban)理、利用办(ban)(ban)(ban)理、监视办(ban)(ban)(ban)理四个方面临中药(yao)(yao)配(pei)方颗(ke)(ke)粒办(ban)(ban)(ban)理提(ti)出(chu)了请求。另外,山(shan)西(xi)(xi)(xi)省药(yao)(yao)监局还印(yin)(yin)发(fa)了《山(shan)西(xi)(xi)(xi)省中药(yao)(yao)配(pei)方颗(ke)(ke)粒规(gui)范(fan)》,8批品质规(gui)范(fan)正在公示。
河南。10月27日,河(he)南(nan)省(sheng)药(yao)监局宣布《河(he)南(nan)省(sheng)中药(yao)配方颗(ke)(ke)粒(li)办理(li)细(xi)则(试行)》(收(shou)罗(luo)定见稿(gao))。《收(shou)罗(luo)定见稿(gao)》共(gong)六章24条(tiao),触及出产(chan)企业根基前提、出产(chan)办理(li)、利(li)用办理(li)、监视办理(li)等(deng)外(wai)容。另外(wai),河(he)南(nan)省(sheng)药(yao)监局还(hai)拟定了《河(he)南(nan)省(sheng)中药(yao)配方颗(ke)(ke)粒ꦅ(li)规范》,今朝1批10此中药(yao)配方颗(ke)(ke)粒(li)规范正在(zai)公示。
广西。9月30日,广西(xi)壮族自(zi)治区药(yao)监局印发(fa)《广西(xi)壮族自(zi)治区中(zhong)药(yao)配(pei)方颗(ke)(ke)粒办理细则(公然收(shou)罗(luo)(luo)定见(jian)稿)》。《收(shou)罗(luo)(luo)定见(jian)稿》共十章(zhang)46条(tiao),触及✱中(zhong)药(yao)配(pei)方♎颗(ke)(ke)粒的备案、出产、发(fa)卖、配(pei)送(song)、利(li)用、医保付出、羁(ji)系等外容。另(ling)外,广西(xi)壮族自(zi)治区药(yao)监局还对3此中(zhong)药(yao)配(pei)方颗(ke)(ke)粒规范停止公示。
甘肃。10月15日,甘(gan)肃(su)省(sheng)(sheng)药(yao)监(jian)局印发《甘(gan)肃(su)省(sheng)(sheng)中药(yao)配(pei)方颗粒办(b꧃an)理(li)(li)细则》(收(shou)罗(luo)定见(jian)稿(gao))。《收(shou)罗(luo)定见(jian)稿(gao)》共八章56条(tiao),包罗(luo)📖研制和(he)(he)规(gui)范(fan)、备案办(ban)理(li)(li)、出产办(ban)理(li)(li)、配(pei)送(song)和(he)(he)利用办(ban)理(li)(li)、称(cheng)号和(he)(he)标签、监(jian)视(shi)办(ban)理(li)(li)等(deng)外(wai)(wai)容。《收(shou)罗(luo)定见(jian)稿(gao)》出格提出要与产地加工试点政策相跟尾。另(ling)外(wai)(wai),甘(gan)肃(su)省(sheng)(sheng)药(yao)监(jian)局还宣布了四批195个种(zhong)类的中药(yao)配(pei)方颗粒品质规(gui)范(fan)。
辽宁。辽宁(ning)省(sheng)药监局印(yin)发《辽宁(ning)省(sheng)中药配方颗粒规范》,3批229个种(🎃zhong)类规范在停(ting)止公示。
上海。上海市(shi)药(yao)监局印发《上海市(shi)中(zhong)药(yao)配(pei)方颗粒品质规范(fan)》,今朝4批♔230个种ꦿ(zhong)类在停止公示。
青海。青海(hai)省药监局宣布2批200种中药配方(fang)颗粒品ও质规范,在停(tiꦗng)止(zhi)公示。
停止(zhi)11月5日,内蒙古、福建、湖(h♉u)北、♔西藏(zang)、新疆五个省(区、市)暂(zan)未宣布相干文件。
