J9九游会AG

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学习变(bian)更、规范变(bian)更、防控风险

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学习变更、规范变更、防控风险

  • 分类:新闻公告
  • 作者(zhe):研究所
  • 来源(yuan):湖南J9九游会AG制药股份有限公司
  • 发布时间:2022-06-11 14:45

学习变更、规范变更、防控风险

2021年05月(yue)24日,我司研究(jiu)所组织(zhi)部(bu)门人员学习由国家(jia)药(yao)(yao)(yao)品(pin)监(jian)督(du)管(guan)理局(ju)药(yao)(yao)(yao)品(pin)注册司、国家(jia)药(yao)(yao)(yao)监(jian)局(ju)药(yao)(yao)(yao)品(pin)监(jian)管(guan)司、国家(jia)药(yao)(yao)(yao)监(jian)局(ju)药(yao)(yao)(yao)审中心(xin)主办(ban)(ban)的线上专题(ti)宣(xuan)贯(guan)会,线上宣(xuan)贯(guan)会聚焦《办(ban)(ban)法》本身,由国家(jia)药(yao)(yao)(yao)监(jian)局(ju)药(yao)(yao)(yao)品(pin)注册司司长杨胜、药(yao)(yao)(yao)品(pin)注册司综合处和药(yao)(yao)(yao)品(pin)监(jian)管(guan)司监(jian)管(guan)二处负责人进行(xing)相(xiang)关政策(ce)解读(du)。

《药(yao)品(pin)(pin)上(shang)(shang)市后变更(geng)(geng)管(guan)理(li)(li)(li)办(ban)法(试行)》(以下(xia)简称(cheng)《办(ban)法》)于2021年01月13日正(zheng)式出台,这是我国(guo)首(shou)部专门(men)针对药(yao)品(pin)(pin)上(shang)(shang)市后变更(geng)(geng)管(guan)理(li)(li)(li)工(gong)(gong)作制(zhi)定的(de)(de)规范性(xing)文件,宣贯会旨(zhi)在帮助药(yao)品(pin)(pin)上(shang)(shang)市许(xu)可(ke)持(chi)(chi)(chi)有(you)人(ren)(ren)在上(shang)(shang)市后变更(geng)(geng)工(gong)(gong)作的(de)(de)研(yan)究之(zhi)初就能(neng)考虑(lv)到国(guo)家有(you)关指导(dao)原则(ze)的(de)(de)要求(qiu),避免从源头上(shang)(shang)出现(xian)偏差或重大遗漏,从而提升药(yao)品(pin)(pin)上(shang)(shang)市后变更(geng)(geng)研(yan)究的(de)(de)质(zhi)量(liang)和(he)(he)审(shen)批速度。同时有(you)助于药(yao)品(pin)(pin)上(shang)(shang)市许(xu)可(ke)持(chi)(chi)(chi)有(you)人(ren)(ren)在药(yao)品(pin)(pin)的(de)(de)全(quan)生命周期内不断(duan)改进和(he)(he)优化(hua)生产工(gong)(gong)艺(yi),持(chi)(chi)(chi)续提高药(yao)品(pin)(pin)的(de)(de)质(zhi)量(liang),《办(ban)法》体现(xian)了科(ke)学监管(guan)理(li)(li)(li)念,有(you)机融合药(yao)品(pin)(pin)注册管(guan)理(li)(li)(li)和(he)(he)生产监督(du)管(guan)理(li)(li)(li)要求(qiu)、突出持(chi)(chi)(chi)有(you)人(ren)(ren)变更(geng)(geng)管(guan)理(li)(li)(li),促进持(chi)(chi)(chi)有(you)人(ren)(ren)产品(pin)(pin)要素有(you)序流动、优化(hua)审(shen)评审(shen)批流程,赋予“放管(guan)服”改革新动能(neng)。

参加(jia)此次培(pei)(pei)训会,获益(yi)匪(fei)浅,《办法(fa)》的(de)实施,对(dui)进一(yi)步加(jia)强药(yao)(yao)品上(shang)市后变(bian)(bian)更管(guan)理(li),落(luo)(luo)实药(yao)(yao)品上(shang)市许(xu)可(ke)持有(you)(you)人(ren)(ren)(ren)(以下简称持有(you)(you)人(ren)(ren)(ren))药(yao)(yao)品上(shang)市后变(bian)(bian)更管(guan)理(li)主(zhu)体(ti)责任,规(gui)(gui)(gui)范药(yao)(yao)品上(shang)市后变(bian)(bian)更行(xing)为,保障药(yao)(yao)品安全(quan)(quan)有(you)(you)效和质(zhi)量(liang)(liang)可(ke)控(kong)具有(you)(you)重(zhong)要意义,通(tong)过此次培(pei)(pei)训及学习,使J9九游会AG 企(qi)(qi)业(ye)积极开展变(bian)(bian)更管(guan)理(li)工作,加(jia)深对(dui)变(bian)(bian)更的(de)理(li)解,同(tong)时能够基(ji)于风(feng)(feng)险(xian)管(guan)理(li)对(dui)已上(shang)市药(yao)(yao)品进行(xing)管(guan)理(li),帮助(zhu)J9九游会AG 企(qi)(qi)业(ye)注册人(ren)(ren)(ren)员(yuan)(yuan)、生(sheng)产人(ren)(ren)(ren)员(yuan)(yuan)、质(zhi)量(liang)(liang)管(guan)理(li)人(ren)(ren)(ren)员(yuan)(yuan)、质(zhi)量(liang)(liang)控(kong)制人(ren)(ren)(ren)员(yuan)(yuan)、验证管(guan)理(li)人(ren)(ren)(ren)员(yuan)(yuan)等提高排除风(feng)(feng)险(xian)的(de)能力,降低企(qi)(qi)业(ye)的(de)运行(xing)和合(he)规(gui)(gui)(gui)风(feng)(feng)险(xian)。在(zai)未(wei)来的(de)发(fa)展道(dao)路上(shang),企(qi)(qi)业(ye)自(zi)身还需进一(yi)步落(luo)(luo)实质(zhi)量(liang)(liang)主(zhu)体(ti)责任,完善质(zhi)量(liang)(liang)管(guan)理(li)体(ti)系,强化变(bian)(bian)更管(guan)理(li)控(kong)制,保障药(yao)(yao)品质(zhi)量(liang)(liang)安全(quan)(quan);同(tong)时注重(zhong)研(yan)发(fa)创新,规(gui)(gui)(gui)范变(bian)(bian)更研(yan)究,持续(xu)合(he)规(gui)(gui)(gui)生(sheng)产,有(you)(you)效防控(kong)风(feng)(feng)险(xian)。

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