一、《办法》修订(ding)的背景(jing)是(shi)什么？
药(yao)(yao)(yao)(yao)品(pin)(pin)与人民群众(zhong)健(jian)康(kang)息息相关，党中央、国务(wu)院(yuan)高度(du)重(zhong)视。2015年(nian)以(yi)(yi)(yi)来，先后印(yin)发(fa)《国务(wu)院(yuan)关于(yu)改(gai)革药(yao)(yao)(yao)(yao)品(pin)(pin)医(yi)疗器械(xie)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)制(zhi)(zhi)(zhi)度(du)的(de)(de)意见》（国发(fa)〔2015〕44号(hao)，以(yi)(yi)(yi)下简称44号(hao)文件(jian)）、《关于(yu)深化审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)制(zhi)(zhi)(zhi)度(du)改(gai)革鼓励药(yao)(yao)(yao)(yao)品(pin)(pin)医(yi)疗器械(xie)创(chuang)新的(de)(de)意见》（厅字(zi)〔2017〕42号(hao)，以(yi)(yi)(yi)下简称42号(hao)文件(jian)）等(deng)(deng)重(zhong)要(yao)文件(jian)，部(bu)署推进药(yao)(yao)(yao)(yao)品(pin)(pin)上市(shi)许(xu)(xu)可(ke)(ke)持有人制(zhi)(zhi)(zhi)度(du)试点、药(yao)(yao)(yao)(yao)物(wu)(wu)临(lin)床(chuang)试验默示(shi)许(xu)(xu)可(ke)(ke)、关联审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)、优先审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)等(deng)(deng)一(yi)系(xi)列改(gai)革举措。2019年(nian)6月(yue)和8月(yue)，全(quan)(quan)国人大(da)常委会先后审(shen)(shen)(shen)议(yi)通过《疫苗管(guan)理法(fa)》和新修订(ding)的(de)(de)《药(yao)(yao)(yao)(yao)品(pin)(pin)管(guan)理法(fa)》，于(yu)12月(yue)1日起施行(xing)。两部(bu)法(fa)律全(quan)(quan)面实施药(yao)(yao)(yao)(yao)品(pin)(pin)上市(shi)许(xu)(xu)可(ke)(ke)持有人制(zhi)(zhi)(zhi)度(du)，建立(li)药(yao)(yao)(yao)(yao)物(wu)(wu)临(lin)床(chuang)试验默示(shi)许(xu)(xu)可(ke)(ke)、附条件(jian)批(pi)(pi)准(zhun)、优先审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)、上市(shi)后变(bian)更分(fen)类(lei)管(guan)理等(deng)(deng)一(yi)系(xi)列管(guan)理制(zhi)(zhi)(zhi)度(du)，并要(yao)求完(wan)善药(yao)(yao)(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)工作(zuo)制(zhi)(zhi)(zhi)度(du)，优化审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)流程，提高审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)效(xiao)率。现行(xing)《办(ban)法(fa)》颁布(bu)于(yu)2007年(nian)，在保证药(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)安全(quan)(quan)、有效(xiao)和质(zhi)量可(ke)(ke)控以(yi)(yi)(yi)及规范(fan)药(yao)(yao)(yao)(yao)品(pin)(pin)注册行(xing)为等(deng)(deng)方面发(fa)挥了重(zhong)要(yao)作(zuo)用，但(dan)已不适应新制(zhi)(zhi)(zhi)修订(ding)法(fa)律、药(yao)(yao)(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)制(zhi)(zhi)(zhi)度(du)改(gai)革的(de)(de)要(yao)求以(yi)(yi)(yi)及科(ke)学进步和医(yi)药(yao)(yao)(yao)(yao)行(xing)业快速发(fa)展的(de)(de)需要(yao)，有必要(yao)进行(xing)全(quan)(quan)面修订(ding)。
二、《办法》修订的(de)思路(lu)是什(shen)么(me)？
这次(ci)修订《办法(fa)》，坚持贯彻新制修订法(fa)律要(yao)(yao)求，吸纳药(yao)(yao)品审评审批制度改革成果围绕明确药(yao)(yao)品注册管理(li)(li)(li)工(gong)作(zuo)(zuo)的(de)基(ji)(ji)本要(yao)(yao)求，对药(yao)(yao)品注册的(de)基(ji)(ji)本制度、基(ji)(ji)本原(yuan)则(ze)、基(ji)(ji)本程(cheng)序和各方主要(yao)(yao)责(ze)任义务等作(zuo)(zuo)出规定，突出《办法(fa)》的(de)管理(li)(li)(li)属性。考(kao)虑到(dao)药(yao)(yao)品注册管理(li)(li)(li)中的(de)具体技(ji)术要(yao)(yao)求将(jiang)结(jie)合技(ji)术发展不断调整完善，在(zai)规章(zhang)中不宜作(zuo)(zuo)具体规定，后续将(jiang)以配(pei)套(tao)文件、技(ji)术指导原(yuan)则(ze)等形式(shi)发布，更好地体现药(yao)(yao)品研发的(de)科学规律。
三、如(ru)何加强全生命周期(qi)管理？
这(zhei)次修订《办法(fa)》，在药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)监(jian)(jian)(jian)管(guan)(guan)(guan)(guan)理(li)(li)(li)念方(fang)面(mian)创新，引入药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)全(quan)生(sheng)(sheng)命(ming)周期(qi)(qi)(qi)管(guan)(guan)(guan)(guan)理(li)(li)(li)理(li)(li)(li)念，系(xi)统进(jin)(jin)行(xing)设计，加(jia)强从(cong)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)研(yan)(yan)制上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)、上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)后(hou)(hou)管(guan)(guan)(guan)(guan)理(li)(li)(li)到药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册证书注(zhu)销(xiao)等各环节(jie)全(quan)过程、全(quan)链条的(de)(de)(de)(de)(de)(de)监(jian)(jian)(jian)管(guan)(guan)(guan)(guan)制度：一是增(zeng)加(jia)GLP机(ji)构(gou)、GCP机(ji)构(gou)监(jian)(jian)(jian)督(du)检查相(xiang)(xiang)关内(nei)容，强化(hua)(hua)省(sheng)(sheng)级药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)监(jian)(jian)(jian)督(du)管(guan)(guan)(guan)(guan)理(li)(li)(li)部(bu)门的(de)(de)(de)(de)(de)(de)日(ri)常监(jian)(jian)(jian)管(guan)(guan)(guan)(guan)事权，充分发挥省(sheng)(sheng)级药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)监(jian)(jian)(jian)督(du)管(guan)(guan)(guan)(guan)理(li)(li)(li)部(bu)门监(jian)(jian)(jian)管(guan)(guan)(guan)(guan)作(zuo)用(yong)，保障GLP、GCP持续合规(gui)和(he)(he)(he)(he)(he)(he)工作(zuo)质(zhi)量(liang)。二是明(ming)(ming)(ming)确(que)附条件批准药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)后(hou)(hou)必(bi)须完(wan)成相(xiang)(xiang)应工作(zuo)的(de)(de)(de)(de)(de)(de)时限(xian)(xian)要(yao)(yao)(yao)求，对(dui)(dui)未按时限(xian)(xian)要(yao)(yao)(yao)求完(wan)成的(de)(de)(de)(de)(de)(de)，明(ming)(ming)(ming)确(que)相(xiang)(xiang)应处理(li)(li)(li)措施(shi)，直至撤销(xiao)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册证书。三是增(zeng)设药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)后(hou)(hou)变更(geng)和(he)(he)(he)(he)(he)(he)再注(zhu)册一章，充分体(ti)现(xian)(xian)新修订《药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)管(guan)(guan)(guan)(guan)理(li)(li)(li)法(fa)》的(de)(de)(de)(de)(de)(de)要(yao)(yao)(yao)求，强化(hua)(hua)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)后(hou)(hou)研(yan)(yan)究和(he)(he)(he)(he)(he)(he)变更(geng)管(guan)(guan)(guan)(guan)理(li)(li)(li)相(xiang)(xiang)关要(yao)(yao)(yao)求，要(yao)(yao)(yao)求持有人(ren)主动(dong)开(kai)展药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)后(hou)(hou)研(yan)(yan)究，对(dui)(dui)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)(de)(de)(de)安(an)全(quan)性(xing)、有效性(xing)和(he)(he)(he)(he)(he)(he)质(zhi)量(liang)可控性(xing)进(jin)(jin)行(xing)进(jin)(jin)一步确(que)证，加(jia)强对(dui)(dui)已上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)(de)(de)(de)持续管(guan)(guan)(guan)(guan)理(li)(li)(li)，明(ming)(ming)(ming)确(que)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)后(hou)(hou)变更(geng)分类及申报、备(bei)案和(he)(he)(he)(he)(he)(he)报告(gao)途径，体(ti)现(xian)(xian)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)全(quan)生(sheng)(sheng)命(ming)周期(qi)(qi)(qi)管(guan)(guan)(guan)(guan)理(li)(li)(li)。四是采用(yong)信(xin)息(xi)化(hua)(hua)手段强化(hua)(hua)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册管(guan)(guan)(guan)(guan)理(li)(li)(li)，建立药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)品(pin)(pin)(pin)(pin)(pin)种档(dang)(dang)案，为实现(xian)(xian)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)全(quan)生(sheng)(sheng)命(ming)周期(qi)(qi)(qi)的(de)(de)(de)(de)(de)(de)日(ri)常监(jian)(jian)(jian)管(guan)(guan)(guan)(guan)和(he)(he)(he)(he)(he)(he)各监(jian)(jian)(jian)管(guan)(guan)(guan)(guan)环节(jie)信(xin)息(xi)无缝衔接(jie)(jie)奠(dian)定基础。增(zeng)加(jia)对(dui)(dui)GLP机(ji)构(gou)、GCP机(ji)构(gou)的(de)(de)(de)(de)(de)(de)监(jian)(jian)(jian)管(guan)(guan)(guan)(guan)以及药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)安(an)全(quan)信(xin)用(yong)档(dang)(dang)案的(de)(de)(de)(de)(de)(de)相(xiang)(xiang)关要(yao)(yao)(yao)求。增(zeng)加(jia)信(xin)息(xi)公(gong)(gong)开(kai)内(nei)容，公(gong)(gong)开(kai)审评结论和(he)(he)(he)(he)(he)(he)依据，接(jie)(jie)受社会(hui)监(jian)(jian)(jian)督(du)，促进(jin)(jin)社会(hui)共治(zhi)；将(jiang)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)说(shuo)明(ming)(ming)(ming)书列(lie)为信(xin)息(xi)公(gong)(gong)开(kai)内(nei)容并适时更(geng)新，为公(gong)(gong)众(zhong)查询使(shi)用(yong)提(ti)供(gong)方(fang)便。五是根(gen)据规(gui)章权限(xian)(xian)，对(dui)(dui)法(fa)律规(gui)定应予处罚情形予以适当(dang)细化(hua)(hua)，强化(hua)(hua)对(dui)(dui)监(jian)(jian)(jian)管(guan)(guan)(guan)(guan)人(ren)员(yuan)的(de)(de)(de)(de)(de)(de)责任追究，严(yan)厉打击研(yan)(yan)制环节(jie)数据造(zao)假等违法(fa)违规(gui)行(xing)为，营(ying)造(zao)鼓(gu)励创新的(de)(de)(de)(de)(de)(de)良(liang)好环境(jing)。六是药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)许可申请人(ren)（持有人(ren)）的(de)(de)(de)(de)(de)(de)质(zhi)量(liang)管(guan)(guan)(guan)(guan)理(li)(li)(li)、风险防控和(he)(he)(he)(he)(he)(he)责任赔(pei)偿等能(neng)力的(de)(de)(de)(de)(de)(de)建立和(he)(he)(he)(he)(he)(he)完(wan)善，贯穿于药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)全(quan)生(sheng)(sheng)命(ming)周期(qi)(qi)(qi)各环节(jie)，药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册环节(jie)综(zong)合体(ti)现(xian)(xian)在其对(dui)(dui)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)(de)(de)(de)非临床研(yan)(yan)究、临床试验、药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)试制和(he)(he)(he)(he)(he)(he)生(sheng)(sheng)产(chan)、上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)前检查核(he)查、上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)后(hou)(hou)研(yan)(yan)究、不良(liang)反应报告(gao)与处理(li)(li)(li)以及药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)(sheng)产(chan)和(he)(he)(he)(he)(he)(he)上(shang)(shang)(shang)(shang)(shang)市(shi)(shi)(shi)(shi)(shi)许可等符(fu)合相(xiang)(xiang)应的(de)(de)(de)(de)(de)(de)管(guan)(guan)(guan)(guan)理(li)(li)(li)规(gui)范、标(biao)准和(he)(he)(he)(he)(he)(he)要(yao)(yao)(yao)求；申请人(ren)（持有人(ren)）应当(dang)持续加(jia)强对(dui)(dui)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)全(quan)生(sheng)(sheng)命(ming)周期(qi)(qi)(qi)的(de)(de)(de)(de)(de)(de)管(guan)(guan)(guan)(guan)理(li)(li)(li)，并依法(fa)承担主体(ti)责任。
四、如何贯彻“放(fang)管(guan)服”改(gai)革要(yao)求？
这次修订《办法》，按照(zhao)国务院(yuan)简政(zheng)放权(quan)和(he)“放管(guan)服”要(yao)求，创新(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注册(ce)管(guan)理(li)(li)方式：一(yi)是(shi)(shi)(shi)建立关联(lian)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)制(zhi)(zhi)(zhi)度(du)(du)，根据新(xin)修订《药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)管(guan)理(li)(li)法》规(gui)定，化(hua)学原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)(yao)(yao)按照(zhao)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)管(guan)理(li)(li)，实(shi)(shi)行(xing)审(shen)(shen)(shen)(shen)批(pi)(pi)准入制(zhi)(zhi)(zhi)度(du)(du)。化(hua)学原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)(yao)(yao)生(sheng)(sheng)(sheng)(sheng)产(chan)(chan)企(qi)业(ye)应当按照(zhao)《国家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)局关于进一(yi)步完善药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)关联(lian)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)和(he)监(jian)管(guan)工(gong)作(zuo)有关事宜的(de)(de)(de)公(gong)告》（2019年第(di)56号）的(de)(de)(de)要(yao)求在“原(yuan)(yuan)辅包登(deng)记(ji)平台(tai)”进行(xing)登(deng)记(ji)，并按照(zhao)有关登(deng)记(ji)要(yao)求提(ti)(ti)(ti)交技术(shu)资(zi)料，明(ming)确生(sheng)(sheng)(sheng)(sheng)产(chan)(chan)场地地址等(deng)信息(xi)(xi)。药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)制(zhi)(zhi)(zhi)剂(ji)申(shen)请(qing)人(ren)(ren)自行(xing)生(sheng)(sheng)(sheng)(sheng)产(chan)(chan)化(hua)学原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)，由(you)(you)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)制(zhi)(zhi)(zhi)剂(ji)申(shen)请(qing)人(ren)(ren)在“原(yuan)(yuan)辅包登(deng)记(ji)平台(tai)”登(deng)记(ji)，在提(ti)(ti)(ti)出(chu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)制(zhi)(zhi)(zhi)剂(ji)注册(ce)申(shen)请(qing)时(shi)与其进行(xing)关联(lian)；选择其他化(hua)学原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)(yao)(yao)生(sheng)(sheng)(sheng)(sheng)产(chan)(chan)企(qi)业(ye)的(de)(de)(de)，由(you)(you)化(hua)学原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)(yao)(yao)生(sheng)(sheng)(sheng)(sheng)产(chan)(chan)企(qi)业(ye)在“原(yuan)(yuan)辅包登(deng)记(ji)平台(tai)”登(deng)记(ji)，药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)制(zhi)(zhi)(zhi)剂(ji)申(shen)请(qing)人(ren)(ren)在提(ti)(ti)(ti)出(chu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)制(zhi)(zhi)(zhi)剂(ji)注册(ce)申(shen)请(qing)时(shi)与其进行(xing)关联(lian)。取消辅料及直(zhi)接(jie)(jie)接(jie)(jie)触药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)包装材料和(he)容器的(de)(de)(de)单独审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)事项(xiang)，在审(shen)(shen)(shen)(shen)批(pi)(pi)制(zhi)(zhi)(zhi)剂(ji)时(shi)一(yi)并审(shen)(shen)(shen)(shen)评(ping)，减少(shao)审(shen)(shen)(shen)(shen)批(pi)(pi)事项(xiang)，提(ti)(ti)(ti)高(gao)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)效(xiao)率(lv)的(de)(de)(de)同(tong)时(shi)，更(geng)(geng)加(jia)突出(chu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)制(zhi)(zhi)(zhi)剂(ji)持有人(ren)(ren)对辅料及直(zhi)接(jie)(jie)接(jie)(jie)触药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)包装材料和(he)容器的(de)(de)(de)管(guan)理(li)(li)责(ze)任(ren)和(he)主(zhu)体(ti)地位。二是(shi)(shi)(shi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)临床(chuang)试验(yan)审(shen)(shen)(shen)(shen)批(pi)(pi)实(shi)(shi)施(shi)默示许可(ke)制(zhi)(zhi)(zhi)度(du)(du)，生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)等(deng)效(xiao)性试验(yan)由(you)(you)原(yuan)(yuan)来(lai)的(de)(de)(de)许可(ke)制(zhi)(zhi)(zhi)度(du)(du)改为(wei)备(bei)案(an)(an)制(zhi)(zhi)(zhi)度(du)(du)。三(san)是(shi)(shi)(shi)对药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)变(bian)(bian)更(geng)(geng)实(shi)(shi)行(xing)分(fen)类管(guan)理(li)(li)，中等(deng)程(cheng)(cheng)度(du)(du)变(bian)(bian)更(geng)(geng)由(you)(you)省级药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)监(jian)督管(guan)理(li)(li)部门(men)实(shi)(shi)施(shi)备(bei)案(an)(an)管(guan)理(li)(li)，微小程(cheng)(cheng)度(du)(du)变(bian)(bian)更(geng)(geng)实(shi)(shi)施(shi)企(qi)业(ye)年度(du)(du)报告管(guan)理(li)(li)，同(tong)时(shi)也(ye)进一(yi)步明(ming)确了场地变(bian)(bian)更(geng)(geng)和(he)工(gong)艺变(bian)(bian)更(geng)(geng)的(de)(de)(de)管(guan)理(li)(li)职责(ze)。四是(shi)(shi)(shi)依据产(chan)(chan)品(pin)(pin)(pin)(pin)(pin)(pin)创新(xin)程(cheng)(cheng)度(du)(du)和(he)风险特点(dian)，实(shi)(shi)行(xing)基于风险的(de)(de)(de)审(shen)(shen)(shen)(shen)评(ping)、核(he)查和(he)检(jian)(jian)验(yan)模式，明(ming)确必须(xu)进行(xing)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注册(ce)现场核(he)查的(de)(de)(de)情形，允(yun)许同(tong)步进行(xing)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注册(ce)现场核(he)查和(he)上市前药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)生(sheng)(sheng)(sheng)(sheng)产(chan)(chan)质(zhi)量(liang)管(guan)理(li)(li)规(gui)范检(jian)(jian)查，提(ti)(ti)(ti)高(gao)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)工(gong)作(zuo)效(xiao)率(lv)。五是(shi)(shi)(shi)科学设置药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注册(ce)检(jian)(jian)验(yan)流程(cheng)(cheng)，将药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注册(ce)检(jian)(jian)验(yan)调整为(wei)可(ke)于受理(li)(li)前启动(dong)，申(shen)请(qing)人(ren)(ren)可(ke)以选择在申(shen)请(qing)人(ren)(ren)或者生(sheng)(sheng)(sheng)(sheng)产(chan)(chan)企(qi)业(ye)所在地药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)检(jian)(jian)验(yan)机构进行(xing)检(jian)(jian)验(yan)。六是(shi)(shi)(shi)强(qiang)化(hua)事中事后(hou)监(jian)管(guan)，强(qiang)调研(yan)制(zhi)(zhi)(zhi)行(xing)为(wei)持续合规(gui)，严格(ge)上市后(hou)研(yan)究管(guan)理(li)(li)要(yao)求，加(jia)强(qiang)信息(xi)(xi)公(gong)开(kai)和(he)社(she)会监(jian)督，强(qiang)化(hua)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)全生(sheng)(sheng)(sheng)(sheng)命周期管(guan)理(li)(li)。
五(wu)、如何持续推进(jin)药品审(shen)评(ping)审(shen)批制度改革？
这次修(xiu)订《办法(fa)》，既体(ti)(ti)现(xian)、固(gu)化(hua)药(yao)品领域改(gai)革(ge)(ge)(ge)的(de)(de)成果(guo)，又将(jiang)引领、推动改(gai)革(ge)(ge)(ge)持续、全面深(shen)化(hua)：一是(shi)固(gu)化(hua)药(yao)品审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)制(zhi)(zhi)度(du)(du)(du)改(gai)革(ge)(ge)(ge)成果(guo)。坚决落实(shi)党中央、国(guo)务(wu)院改(gai)革(ge)(ge)(ge)部(bu)署和新(xin)制(zhi)(zhi)修(xiu)订法(fa)律精神，巩固(gu)42号(hao)文(wen)件、44号(hao)文(wen)件部(bu)署的(de)(de)改(gai)革(ge)(ge)(ge)成果(guo)。实(shi)践证(zheng)明行之有效的(de)(de)改(gai)革(ge)(ge)(ge)措施，及时在(zai)部(bu)门规(gui)章中体(ti)(ti)现(xian)，能(neng)够(gou)为审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)制(zhi)(zhi)度(du)(du)(du)改(gai)革(ge)(ge)(ge)提供强(qiang)有力(li)的(de)(de)保障。二是(shi)持续推进(jin)审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)制(zhi)(zhi)度(du)(du)(du)改(gai)革(ge)(ge)(ge)。按照《办法(fa)》修(xiu)订的(de)(de)总体(ti)(ti)思路，《办法(fa)》正文(wen)做原则(ze)性表(biao)述，为将(jiang)来的(de)(de)继续深(shen)化(hua)改(gai)革(ge)(ge)(ge)留有空间。根据新(xin)修(xiu)订《办法(fa)》，国(guo)家局将(jiang)持续推进(jin)审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)制(zhi)(zhi)度(du)(du)(du)改(gai)革(ge)(ge)(ge)，优(you)化(hua)审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)流(liu)程(cheng)，提高审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)效率，建(jian)立(li)以(yi)审(shen)(shen)(shen)评(ping)(ping)为主(zhu)导，检(jian)验(yan)、核查、监(jian)测(ce)与(yu)评(ping)(ping)价等为支撑的(de)(de)药(yao)品注册管理体(ti)(ti)系。
六、引入(ru)了哪些新的理念(nian)和制度？
这次修(xiu)订《办(ban)法(fa)》，与2007版《办(ban)法(fa)》相(xiang)比，引入了许多新(xin)的(de)理(li)念和制度设计：一是(shi)固化(hua)了近些年(nian)药(yao)品(pin)(pin)(pin)审(shen)(shen)评审(shen)(shen)批(pi)制度改(gai)革推出的(de)新(xin)的(de)改(gai)革举措，将药(yao)品(pin)(pin)(pin)监管中一些比较核(he)心的(de)新(xin)制度在(zai)新(xin)修(xiu)订《办(ban)法(fa)》中体现(xian)。比如(ru)药(yao)品(pin)(pin)(pin)上(shang)市(shi)许可(ke)持有人(ren)制度、药(yao)物临床试验默示许可(ke)、优先审(shen)(shen)评审(shen)(shen)批(pi)、原辅包和制剂关联审(shen)(shen)评审(shen)(shen)批(pi)、沟通交流(liu)、专家咨询等(deng)新(xin)制度。二是(shi)进(jin)一步优化(hua)审(shen)(shen)评审(shen)(shen)批(pi)程(cheng)序。比如(ru)药(yao)品(pin)(pin)(pin)注册(ce)(ce)检验可(ke)以在(zai)受(shou)理(li)前启动、药(yao)品(pin)(pin)(pin)注册(ce)(ce)现(xian)场核(he)查(cha)和上(shang)市(shi)前药(yao)品(pin)(pin)(pin)生产质量管理(li)规(gui)范(fan)检查(cha)同(tong)步实施等(deng)新(xin)理(li)念。
七、有哪(na)些鼓励(li)药物研制和创(chuang)新(xin)的新(xin)举措(cuo)？
创新是推动药(yao)品高(gao)质量发展的力量源泉。这(zhei)次修(xiu)订《办法》，充实了鼓励(li)药(yao)物研制和创新的内容，以提高(gao)药(yao)品可及性：一是结(jie)合我(wo)国(guo)医药(yao)产业发展和临床(chuang)治疗需求实际(ji)，参(can)考国(guo)际(ji)经验，增设(she)(she)药(yao)品加(jia)快(kuai)上(shang)市注册程序(xu)一章，设(she)(she)立突破(po)性治疗药(yao)物、附条件(jian)批准、优先(xian)审评审批、特别审批四个加(jia)快(kuai)通道(dao)，并明确每个通道(dao)的纳入(ru)范(fan)(fan)围(wei)、程序(xu)、支持政(zheng)策等要求。二是将《药(yao)品管理法》《疫苗管理法》及国(guo)务院文(wen)件(jian)中列明的临床(chuang)急需的短缺(que)药(yao)、儿(er)童用(yong)药(yao)、罕见病用(yong)药(yao)、重(zhong)大传(chuan)染(ran)病用(yong)药(yao)、疾病防控急需疫苗和创新疫苗等均明确纳入(ru)加(jia)快(kuai)上(shang)市注册范(fan)(fan)围(wei)。
八、如何体现药(yao)物研制和注册规(gui)律(lv)？
这次修订《办法(fa)》，更(geng)加注(zhu)重药(yao)(yao)(yao)物研制(zhi)(zhi)和(he)(he)注(zhu)册(ce)(ce)管理(li)(li)(li)(li)的科(ke)学规律：一是(shi)(shi)将沟(gou)(gou)通(tong)交(jiao)流(liu)制(zhi)(zhi)度(du)(du)纳(na)入药(yao)(yao)(yao)品(pin)(pin)注(zhu)册(ce)(ce)管理(li)(li)(li)(li)的基本制(zhi)(zhi)度(du)(du)。良好的沟(gou)(gou)通(tong)交(jiao)流(liu)是(shi)(shi)提高审(shen)评(ping)(ping)审(shen)批质量和(he)(he)效率的基础。一方面(mian)，申请(qing)人(ren)在(zai)药(yao)(yao)(yao)物临(lin)(lin)床(chuang)试(shi)(shi)验申请(qing)前、药(yao)(yao)(yao)物临(lin)(lin)床(chuang)试(shi)(shi)验过程(cheng)中(zhong)以(yi)及药(yao)(yao)(yao)品(pin)(pin)上(shang)(shang)(shang)市(shi)(shi)许(xu)可(ke)申请(qing)前等(deng)关键阶段，可(ke)以(yi)就(jiu)重大问(wen)题(ti)与药(yao)(yao)(yao)品(pin)(pin)审(shen)评(ping)(ping)中(zhong)心(xin)等(deng)专业技(ji)术机(ji)(ji)构(gou)进(jin)行(xing)(xing)沟(gou)(gou)通(tong)交(jiao)流(liu)；另一方面(mian)，药(yao)(yao)(yao)品(pin)(pin)注(zhu)册(ce)(ce)过程(cheng)中(zhong)，药(yao)(yao)(yao)品(pin)(pin)审(shen)评(ping)(ping)中(zhong)心(xin)等(deng)专业技(ji)术机(ji)(ji)构(gou)可(ke)以(yi)根据工作需要组(zu)织(zhi)与申请(qing)人(ren)进(jin)行(xing)(xing)沟(gou)(gou)通(tong)交(jiao)流(liu)。二是(shi)(shi)建(jian)立了(le)(le)符合药(yao)(yao)(yao)物临(lin)(lin)床(chuang)试(shi)(shi)验特点的管理(li)(li)(li)(li)制(zhi)(zhi)度(du)(du)。比(bi)如对药(yao)(yao)(yao)物临(lin)(lin)床(chuang)试(shi)(shi)验实(shi)施(shi)默示许(xu)可(ke)，生物等(deng)效性试(shi)(shi)验实(shi)施(shi)备案；从对受试(shi)(shi)者安全的保(bao)护角度(du)(du)，明确了(le)(le)药(yao)(yao)(yao)物临(lin)(lin)床(chuang)试(shi)(shi)验期间变(bian)更(geng)的管理(li)(li)(li)(li)和(he)(he)申报(bao)路(lu)径等(deng)。三是(shi)(shi)建(jian)立了(le)(le)更(geng)加符合药(yao)(yao)(yao)物研制(zhi)(zhi)和(he)(he)监管实(shi)践(jian)的上(shang)(shang)(shang)市(shi)(shi)许(xu)可(ke)和(he)(he)上(shang)(shang)(shang)市(shi)(shi)后变(bian)更(geng)管理(li)(li)(li)(li)制(zhi)(zhi)度(du)(du)。药(yao)(yao)(yao)品(pin)(pin)上(shang)(shang)(shang)市(shi)(shi)许(xu)可(ke)有完(wan)整路(lu)径、直接(jie)申报(bao)上(shang)(shang)(shang)市(shi)(shi)路(lu)径和(he)(he)非处方药(yao)(yao)(yao)路(lu)径，优化(hua)了(le)(le)申报(bao)和(he)(he)审(shen)批程(cheng)序。药(yao)(yao)(yao)品(pin)(pin)上(shang)(shang)(shang)市(shi)(shi)后变(bian)更(geng)按照审(shen)批、备案和(he)(he)报(bao)告事项进(jin)行(xing)(xing)分(fen)类管理(li)(li)(li)(li)。
九、如何鼓励中(zhong)药传(chuan)承(cheng)和(he)创新？
支持(chi)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)传承和(he)创新(xin)(xin)，一直(zhi)是药(yao)(yao)(yao)品监管工作的(de)重(zhong)要内容。为突出(chu)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)优势，充分考虑中(zhong)(zhong)(zhong)药(yao)(yao)(yao)特点，这次修订《办法(fa)》明(ming)确国家鼓励(li)运(yun)用现代科学技术和(he)传统(tong)研究(jiu)方法(fa)研制中(zhong)(zhong)(zhong)药(yao)(yao)(yao)，建(jian)立和(he)完善中(zhong)(zhong)(zhong)药(yao)(yao)(yao)特点的(de)注册分类和(he)技术评(ping)价体系，促进(jin)(jin)(jin)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)传承创新(xin)(xin)，同时(shi)注重(zhong)对中(zhong)(zhong)(zhong)药(yao)(yao)(yao)资源的(de)保(bao)护(hu)，促进(jin)(jin)(jin)资源可持(chi)续利用。后(hou)续,将制定中(zhong)(zhong)(zhong)药(yao)(yao)(yao)注册管理(li)的(de)专门规定，更(geng)好地促进(jin)(jin)(jin)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)产业高质(zhi)量发(fa)展。
十、药物临(lin)床试验管(guan)理进行了哪些(xie)优化(hua)和强化(hua)？
这次修订《办(ban)(ban)法》，对(dui)(dui)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)的(de)(de)(de)(de)许(xu)可(ke)备案(an)(an)(an)以及药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)过程(cheng)的(de)(de)(de)(de)管(guan)理进行细化和(he)优化：一是(shi)(shi)(shi)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)申(shen)请(qing)自受(shou)理之日起六十(shi)日内决(jue)定(ding)(ding)是(shi)(shi)(shi)否同意(yi)(yi)(yi)开(kai)展(zhan)，并通过药(yao)(yao)(yao)(yao)(yao)品(pin)审评中心网站通知申(shen)请(qing)人审批结果；逾期(qi)(qi)(qi)未(wei)通知的(de)(de)(de)(de)，视为同意(yi)(yi)(yi)，申(shen)请(qing)人可(ke)以按照(zhao)提(ti)交(jiao)的(de)(de)(de)(de)方案(an)(an)(an)开(kai)展(zhan)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)。申(shen)请(qing)人拟(ni)开(kai)展(zhan)生(sheng)物(wu)(wu)(wu)(wu)等(deng)(deng)效性(xing)(xing)(xing)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)的(de)(de)(de)(de)，在(zai)(zai)完成生(sheng)物(wu)(wu)(wu)(wu)等(deng)(deng)效性(xing)(xing)(xing)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)备案(an)(an)(an)后，按照(zhao)备案(an)(an)(an)的(de)(de)(de)(de)方案(an)(an)(an)开(kai)展(zhan)相关研(yan)究工作(zuo)。二是(shi)(shi)(shi)强(qiang)化了药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)的(de)(de)(de)(de)过程(cheng)管(guan)理。在(zai)(zai)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)期(qi)(qi)(qi)间，申(shen)办(ban)(ban)者应(ying)当定(ding)(ding)期(qi)(qi)(qi)提(ti)交(jiao)研(yan)发期(qi)(qi)(qi)间安全(quan)(quan)性(xing)(xing)(xing)更(geng)新(xin)报告、报告药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)期(qi)(qi)(qi)间出(chu)现(xian)的(de)(de)(de)(de)可(ke)疑且非预期(qi)(qi)(qi)严重不良(liang)反(fan)应(ying)和(he)其他潜在(zai)(zai)的(de)(de)(de)(de)严重安全(quan)(quan)性(xing)(xing)(xing)风(feng)险(xian)信息(xi)。根据(ju)安全(quan)(quan)性(xing)(xing)(xing)风(feng)险(xian)严重程(cheng)度，可(ke)以要求申(shen)办(ban)(ban)者采取调整药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)方案(an)(an)(an)、知情同意(yi)(yi)(yi)书、研(yan)究者手(shou)册(ce)等(deng)(deng)加(jia)强(qiang)风(feng)险(xian)控(kong)制的(de)(de)(de)(de)措施，必要时可(ke)以要求申(shen)办(ban)(ban)者暂停(ting)或(huo)(huo)者终止药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)。三是(shi)(shi)(shi)新(xin)增(zeng)了药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)变更(geng)的(de)(de)(de)(de)路径(jing)。药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)期(qi)(qi)(qi)间发生(sheng)的(de)(de)(de)(de)变更(geng)，根据(ju)对(dui)(dui)受(shou)试(shi)(shi)(shi)(shi)者安全(quan)(quan)的(de)(de)(de)(de)影响(xiang)进行相应(ying)的(de)(de)(de)(de)申(shen)报或(huo)(huo)者报告。四是(shi)(shi)(shi)明确了药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)实施的(de)(de)(de)(de)标准。明确了药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)申(shen)请(qing)自获准之日起，三年内未(wei)有受(shou)试(shi)(shi)(shi)(shi)者签署知情同意(yi)(yi)(yi)书的(de)(de)(de)(de)，该(gai)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)许(xu)可(ke)自行失(shi)效。提(ti)出(chu)了药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)登记的(de)(de)(de)(de)要求。五是(shi)(shi)(shi)在(zai)(zai)法律责任中增(zeng)加(jia)了未(wei)按规定(ding)(ding)开(kai)展(zhan)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)(lin)床(chuang)(chuang)试(shi)(shi)(shi)(shi)验(yan)(yan)(yan)情况的(de)(de)(de)(de)相应(ying)罚则。
十一、药品上市许可路(lu)径进行了哪些(xie)优化？
《办(ban)法(fa)》明(ming)确了三(san)种申请药(yao)品上(shang)(shang)(shang)市许可(ke)(ke)的(de)路(lu)径(jing)：一是(shi)完成支(zhi)持药(yao)品上(shang)(shang)(shang)市注册的(de)药(yao)学、药(yao)理毒理学和药(yao)物临(lin)床(chuang)(chuang)试(shi)验(yan)等(deng)研究(jiu)，确定质(zhi)量(liang)标准，完成商业(ye)规模生产工艺验(yan)证后完整的(de)申报路(lu)径(jing)。二是(shi)经申请人评估无需或不能(neng)开展药(yao)物临(lin)床(chuang)(chuang)试(shi)验(yan)，符合豁免药(yao)物临(lin)床(chuang)(chuang)试(shi)验(yan)条件(jian)的(de)，申请人可(ke)(ke)以直接提出药(yao)品上(shang)(shang)(shang)市许可(ke)(ke)申请的(de)路(lu)径(jing)。三(san)是(shi)非处方药(yao)可(ke)(ke)以直接提出上(shang)(shang)(shang)市许可(ke)(ke)申请的(de)路(lu)径(jing)。
十二、药(yao)品注(zhu)册核查程序进(jin)行了哪些优化(hua)？
这次修订《办法》，对(dui)(dui)药(yao)(yao)品(pin)(pin)(pin)注(zhu)(zhu)册(ce)(ce)(ce)(ce)现(xian)场(chang)(chang)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)进行了(le)优化：一是(shi)(shi)优化了(le)药(yao)(yao)品(pin)(pin)(pin)注(zhu)(zhu)册(ce)(ce)(ce)(ce)现(xian)场(chang)(chang)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)模式。不再实施“逢审必查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)”的(de)(de)(de)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)模式，对(dui)(dui)于药(yao)(yao)品(pin)(pin)(pin)注(zhu)(zhu)册(ce)(ce)(ce)(ce)研(yan)制现(xian)场(chang)(chang)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)，根据(ju)药(yao)(yao)物创(chuang)新程(cheng)度、药(yao)(yao)物研(yan)究机(ji)构既(ji)往接(jie)受(shou)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)情(qing)(qing)况等(deng)，基于风险决(jue)定是(shi)(shi)否(fou)开(kai)展(zhan)；对(dui)(dui)于药(yao)(yao)品(pin)(pin)(pin)注(zhu)(zhu)册(ce)(ce)(ce)(ce)生(sheng)(sheng)(sheng)产现(xian)场(chang)(chang)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)，根据(ju)申报注(zhu)(zhu)册(ce)(ce)(ce)(ce)的(de)(de)(de)品(pin)(pin)(pin)种、工艺、设施、既(ji)往接(jie)受(shou)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)情(qing)(qing)况等(deng)因素，基于风险决(jue)定是(shi)(shi)否(fou)开(kai)展(zhan)。二是(shi)(shi)做好(hao)药(yao)(yao)品(pin)(pin)(pin)注(zhu)(zhu)册(ce)(ce)(ce)(ce)生(sheng)(sheng)(sheng)产现(xian)场(chang)(chang)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)和上市(shi)前药(yao)(yao)品(pin)(pin)(pin)生(sheng)(sheng)(sheng)产质(zhi)量管(guan)(guan)理(li)规(gui)范(fan)检查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)的(de)(de)(de)衔接(jie)，需要上市(shi)前药(yao)(yao)品(pin)(pin)(pin)生(sheng)(sheng)(sheng)产质(zhi)量管(guan)(guan)理(li)规(gui)范(fan)检查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)的(de)(de)(de)，由药(yao)(yao)品(pin)(pin)(pin)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)中心协调(diao)相关省(sheng)级(ji)药(yao)(yao)品(pin)(pin)(pin)监(jian)督管(guan)(guan)理(li)部门与药(yao)(yao)品(pin)(pin)(pin)注(zhu)(zhu)册(ce)(ce)(ce)(ce)生(sheng)(sheng)(sheng)产现(xian)场(chang)(chang)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)同(tong)步实施，加快了(le)药(yao)(yao)品(pin)(pin)(pin)上市(shi)进程(cheng)，与药(yao)(yao)品(pin)(pin)(pin)上市(shi)后监(jian)管(guan)(guan)进行有机(ji)衔接(jie)。三是(shi)(shi)明确(que)了(le)药(yao)(yao)品(pin)(pin)(pin)注(zhu)(zhu)册(ce)(ce)(ce)(ce)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)的(de)(de)(de)定位，药(yao)(yao)品(pin)(pin)(pin)注(zhu)(zhu)册(ce)(ce)(ce)(ce)核(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)不是(shi)(shi)全体系的(de)(de)(de)药(yao)(yao)品(pin)(pin)(pin)生(sheng)(sheng)(sheng)产质(zhi)量管(guan)(guan)理(li)规(gui)范(fan)检查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)，其主要目的(de)(de)(de)是(shi)(shi)核(he)(he)(he)实申报资料的(de)(de)(de)真(zhen)实性、一致性以及药(yao)(yao)品(pin)(pin)(pin)上市(shi)商业化生(sheng)(sheng)(sheng)产条件(jian)，检查(cha)(cha)(cha)(cha)(cha)(cha)(cha)(cha)药(yao)(yao)品(pin)(pin)(pin)研(yan)制的(de)(de)(de)合(he)规(gui)性、数据(ju)可靠性等(deng)。
十三、药品注册(ce)检(jian)验(yan)程序进行了哪些优化(hua)？
这次修订《办法(fa)》，对药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)(zhu)册(ce)检(jian)验(yan)程序(xu)进行了优(you)化(hua)：申请(qing)(qing)人(ren)可(ke)以在(zai)完成(cheng)支持药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)上(shang)市(shi)的药(yao)(yao)学(xue)相关研究，确定质量标准(zhun)，并完成(cheng)商业规(gui)模(mo)生产(chan)工艺验(yan)证后，可(ke)以在(zai)药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)(zhu)册(ce)申请(qing)(qing)受理(li)前提出(chu)药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)(zhu)册(ce)检(jian)验(yan)，在(zai)药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)(zhu)册(ce)申请(qing)(qing)受理(li)前未(wei)提出(chu)药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)(zhu)册(ce)检(jian)验(yan)的，由药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)审(shen)评中心(xin)在(zai)受理(li)后四(si)十日(ri)内启动。药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)检(jian)验(yan)机构原则上(shang)应当在(zai)审(shen)评时限(xian)届满四(si)十日(ri)前，将(jiang)标准(zhun)复核意(yi)见(jian)和检(jian)验(yan)报(bao)告(gao)反(fan)馈(kui)至药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)审(shen)评中心(xin)。在(zai)要求不(bu)减少、标准(zhun)不(bu)降低的前提下，根据产(chan)品(pin)(pin)(pin)(pin)(pin)研发的实际(ji)进展(zhan)，科学(xue)合(he)理(li)地(di)设(she)置、优(you)化(hua)注(zhu)(zhu)(zhu)册(ce)流程，缩短上(shang)市(shi)注(zhu)(zhu)(zhu)册(ce)审(shen)评审(shen)批总(zong)时限(xian)。
十四、药品变更管(guan)理做了哪些(xie)优(you)化？
这次修(xiu)订(ding)《办法(fa)》，根据药(yao)(yao)物(wu)(wu)(wu)研(yan)制规律，对(dui)(dui)现有(you)的(de)药(yao)(yao)品(pin)上(shang)市(shi)后变(bian)(bian)(bian)更(geng)程序(xu)和(he)要(yao)求(qiu)进行优化(hua)，并且新明(ming)确药(yao)(yao)物(wu)(wu)(wu)临(lin)床(chuang)试(shi)验期间(jian)变(bian)(bian)(bian)更(geng)和(he)药(yao)(yao)品(pin)上(shang)市(shi)许可审(shen)(shen)评(ping)期间(jian)变(bian)(bian)(bian)更(geng)的(de)路径：一(yi)是明(ming)确药(yao)(yao)物(wu)(wu)(wu)临(lin)床(chuang)试(shi)验期间(jian)变(bian)(bian)(bian)更(geng)的(de)程序(xu)和(he)要(yao)求(qiu)。对(dui)(dui)于临(lin)床(chuang)试(shi)验期间(jian)变(bian)(bian)(bian)更(geng)的(de)管(guan)理(li)，尊重药(yao)(yao)物(wu)(wu)(wu)研(yan)制规律，增加了对(dui)(dui)药(yao)(yao)物(wu)(wu)(wu)临(lin)床(chuang)试(shi)验期间(jian)变(bian)(bian)(bian)更(geng)要(yao)求(qiu)和(he)程序(xu)，根据对(dui)(dui)受试(shi)者安全的(de)影(ying)响程度采取申(shen)报(bao)(bao)变(bian)(bian)(bian)更(geng)或(huo)报(bao)(bao)告(gao)的(de)方(fang)式进行管(guan)理(li)。二是明(ming)确了上(shang)市(shi)审(shen)(shen)评(ping)期间(jian)的(de)变(bian)(bian)(bian)更(geng)管(guan)理(li)原(yuan)(yuan)则(ze)。上(shang)市(shi)许可审(shen)(shen)评(ping)期间(jian)，发生可能(neng)影(ying)响药(yao)(yao)品(pin)安全性(xing)、有(you)效(xiao)性(xing)和(he)质量可控(kong)性(xing)的(de)重大(da)变(bian)(bian)(bian)更(geng)的(de)，申(shen)请(qing)(qing)人应当撤回原(yuan)(yuan)注册申(shen)请(qing)(qing)，补充研(yan)究后重新申(shen)报(bao)(bao)；不(bu)涉及技(ji)术(shu)内容(rong)的(de)变(bian)(bian)(bian)更(geng)，应当及时告(gao)知药(yao)(yao)品(pin)审(shen)(shen)评(ping)中心并提交相(xiang)关证(zheng)明(ming)性(xing)材料。三是对(dui)(dui)于上(shang)市(shi)后变(bian)(bian)(bian)更(geng)的(de)管(guan)理(li)，在原(yuan)(yuan)《办法(fa)》规定需要(yao)报(bao)(bao)补充申(shen)请(qing)(qing)和(he)备案的(de)基础上(shang)，增加了年度报(bao)(bao)告(gao)的(de)途径。四是生产(chan)场(chang)地变(bian)(bian)(bian)更(geng)需要(yao)按照《药(yao)(yao)品(pin)生产(chan)监督管(guan)理(li)办法(fa)》第十(shi)六条的(de)规定执行。
十五、补充资料程(cheng)序进行了哪些优化？
这次(ci)修订《办法》，对补(bu)(bu)充(chong)(chong)资(zi)(zi)(zi)料(liao)(liao)(liao)的(de)(de)(de)(de)(de)程序和要(yao)(yao)(yao)求(qiu)(qiu)进(jin)行(xing)了细化和优化：一(yi)是需要(yao)(yao)(yao)申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)在原(yuan)申(shen)(shen)(shen)(shen)(shen)报(bao)(bao)资(zi)(zi)(zi)料(liao)(liao)(liao)基(ji)础上补(bu)(bu)充(chong)(chong)新(xin)(xin)的(de)(de)(de)(de)(de)技术资(zi)(zi)(zi)料(liao)(liao)(liao)，即(ji)有(you)新(xin)(xin)的(de)(de)(de)(de)(de)研(yan)(yan)究数据需要(yao)(yao)(yao)再(zai)次(ci)进(jin)行(xing)审(shen)评(ping)的(de)(de)(de)(de)(de)，药品审(shen)评(ping)中心发出(chu)补(bu)(bu)充(chong)(chong)资(zi)(zi)(zi)料(liao)(liao)(liao)要(yao)(yao)(yao)求(qiu)(qiu)时(shi)列(lie)明全部问(wen)题，原(yuan)则上只(zhi)能(neng)提出(chu)一(yi)次(ci)补(bu)(bu)充(chong)(chong)资(zi)(zi)(zi)料(liao)(liao)(liao)要(yao)(yao)(yao)求(qiu)(qiu)，申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)应当按(an)要(yao)(yao)(yao)求(qiu)(qiu)一(yi)次(ci)性提交全部补(bu)(bu)充(chong)(chong)资(zi)(zi)(zi)料(liao)(liao)(liao)，此(ci)种(zhong)补(bu)(bu)充(chong)(chong)资(zi)(zi)(zi)料(liao)(liao)(liao)的(de)(de)(de)(de)(de)时(shi)限是八十日。二是新(xin)(xin)增(zeng)了对申(shen)(shen)(shen)(shen)(shen)报(bao)(bao)资(zi)(zi)(zi)料(liao)(liao)(liao)解释(shi)说(shuo)明的(de)(de)(de)(de)(de)途径，需要(yao)(yao)(yao)申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)仅对原(yuan)申(shen)(shen)(shen)(shen)(shen)报(bao)(bao)资(zi)(zi)(zi)料(liao)(liao)(liao)进(jin)行(xing)解释(shi)说(shuo)明，不需要(yao)(yao)(yao)补(bu)(bu)充(chong)(chong)新(xin)(xin)的(de)(de)(de)(de)(de)研(yan)(yan)究数据。此(ci)种(zhong)补(bu)(bu)充(chong)(chong)资(zi)(zi)(zi)料(liao)(liao)(liao)的(de)(de)(de)(de)(de)时(shi)限是五日，审(shen)评(ping)计时(shi)不停摆。三是药物(wu)临床(chuang)试(shi)验申(shen)(shen)(shen)(shen)(shen)请、药物(wu)临床(chuang)试(shi)验期间(jian)的(de)(de)(de)(de)(de)补(bu)(bu)充(chong)(chong)申(shen)(shen)(shen)(shen)(shen)请实施默示许(xu)(xu)可(ke)，由于(yu)时(shi)限仅有(you)六十日，因(yin)此(ci)在审(shen)评(ping)期间(jian)，不得(de)补(bu)(bu)充(chong)(chong)新(xin)(xin)的(de)(de)(de)(de)(de)技术资(zi)(zi)(zi)料(liao)(liao)(liao)，仅允许(xu)(xu)对原(yuan)申(shen)(shen)(shen)(shen)(shen)报(bao)(bao)资(zi)(zi)(zi)料(liao)(liao)(liao)进(jin)行(xing)解释(shi)说(shuo)明。四(si)是存(cun)在实质(zhi)性缺陷(xian)无法补(bu)(bu)正的(de)(de)(de)(de)(de)，不再(zai)要(yao)(yao)(yao)求(qiu)(qiu)申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)补(bu)(bu)充(chong)(chong)资(zi)(zi)(zi)料(liao)(liao)(liao)，基(ji)于(yu)已有(you)申(shen)(shen)(shen)(shen)(shen)报(bao)(bao)资(zi)(zi)(zi)料(liao)(liao)(liao)做出(chu)不予批(pi)准(zhun)的(de)(de)(de)(de)(de)决(jue)定。五是申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)未能(neng)在上述规定时(shi)限内补(bu)(bu)充(chong)(chong)资(zi)(zi)(zi)料(liao)(liao)(liao)的(de)(de)(de)(de)(de)，该(gai)药品注册申(shen)(shen)(shen)(shen)(shen)请不予批(pi)准(zhun)。
十六、如何(he)实现药品注册时限可(ke)预期？
这次(ci)修订《办法》，对业(ye)界普遍关(guan)心的(de)药品注(zhu)(zhu)册(ce)(ce)时(shi)限(xian)进行了优化：一是明(ming)确药品注(zhu)(zhu)册(ce)(ce)管理(li)各(ge)环(huan)节各(ge)部(bu)门的(de)职责，做好药品注(zhu)(zhu)册(ce)(ce)受(shou)理(li)、审(shen)(shen)评、核查(cha)和检(jian)验(yan)等各(ge)环(huan)节的(de)衔接，提(ti)高药品注(zhu)(zhu)册(ce)(ce)效(xiao)率和注(zhu)(zhu)册(ce)(ce)时(shi)限(xian)的(de)预期(qi)性。二是明(ming)晰(xi)各(ge)项(xiang)具体(ti)工作的(de)负(fu)责部(bu)门，将(jiang)(jiang)各(ge)项(xiang)具体(ti)工作明(ming)确到具体(ti)负(fu)责的(de)有关(guan)单位。三是将(jiang)(jiang)原来的(de)审(shen)(shen)评、核查(cha)和检(jian)验(yan)由“串联”改成“并联”，在审(shen)(shen)评时(shi)限(xian)的(de)二百日内(nei)，明(ming)确审(shen)(shen)评过程中提(ti)出核查(cha)检(jian)验(yan)启(qi)动时(shi)间点(dian)为(wei)受(shou)理(li)后四十(shi)(shi)日内(nei)，完成时(shi)间点(dian)为(wei)审(shen)(shen)评时(shi)限(xian)结束前四十(shi)(shi)日，保证总时(shi)限(xian)可控。
十七、如何(he)做到(dao)药品注册(ce)工作(zuo)公开透明(ming)？
提(ti)高审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)透(tou)明(ming)(ming)度(du)是近年来药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)制(zhi)度(du)改革的(de)(de)重要(yao)任(ren)务。这次修(xiu)订《办法》在总则(ze)明(ming)(ming)确了药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注册管理遵循公(gong)(gong)(gong)开、公(gong)(gong)(gong)平、公(gong)(gong)(gong)正的(de)(de)原则(ze)，并在《办法》正文加强(qiang)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)过(guo)程公(gong)(gong)(gong)开透(tou)明(ming)(ming)、加强(qiang)社(she)会(hui)(hui)监(jian)督(du)、保(bao)护持有人(ren)合法权益和(he)保(bao)障审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)公(gong)(gong)(gong)平公(gong)(gong)(gong)正作(zuo)出(chu)清(qing)(qing)晰(xi)的(de)(de)规定：一是国家局依法向(xiang)社(she)会(hui)(hui)公(gong)(gong)(gong)布药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注册审(shen)(shen)批(pi)(pi)事项清(qing)(qing)单(dan)及法律依据(ju)、审(shen)(shen)批(pi)(pi)要(yao)求和(he)办理时(shi)限(xian)，向(xiang)申请(qing)人(ren)公(gong)(gong)(gong)开药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注册进度(du)，公(gong)(gong)(gong)示药(yao)(yao)(yao)(yao)物(wu)临(lin)床试验结果信(xin)息，向(xiang)社(she)会(hui)(hui)公(gong)(gong)(gong)开批(pi)(pi)准上市药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)审(shen)(shen)评(ping)(ping)结论和(he)依据(ju)以(yi)及监(jian)督(du)检查(cha)发现的(de)(de)违(wei)法违(wei)规行为(wei)，接受社(she)会(hui)(hui)监(jian)督(du)，实现社(she)会(hui)(hui)共治(zhi)。二(er)是批(pi)(pi)准上市药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)说明(ming)(ming)书(shu)应(ying)当(dang)向(xiang)社(she)会(hui)(hui)公(gong)(gong)(gong)开并及时(shi)更(geng)新(xin)(xin)。其中，疫(yi)苗还应(ying)当(dang)公(gong)(gong)(gong)开标签内容并及时(shi)更(geng)新(xin)(xin)。三(san)是建立收载新(xin)(xin)批(pi)(pi)准上市以(yi)及通过(guo)仿制(zhi)药(yao)(yao)(yao)(yao)质量和(he)疗(liao)效一致(zhi)性评(ping)(ping)价的(de)(de)化学(xue)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)目录(lu)集，载明(ming)(ming)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)名(ming)称、活性成分(fen)、剂型(xing)、规格(ge)、是否为(wei)参比(bi)制(zhi)剂、持有人(ren)等相关信(xin)息，及时(shi)更(geng)新(xin)(xin)并向(xiang)社(she)会(hui)(hui)公(gong)(gong)(gong)开。
十八、对药品(pin)注册申请(qing)的审(shen)(shen)评审(shen)(shen)批结论有(you)争议时有(you)哪些救济途径？
这次(ci)修(xiu)订《办(ban)(ban)法》，根据前期改革经验，对(dui)药(yao)品注册申请(qing)审(shen)(shen)评(ping)审(shen)(shen)批(pi)结(jie)(jie)论有争议的(de)(de)救济途(tu)径进(jin)行了优化：一是(shi)为简化程序，提(ti)高实效，新(xin)修(xiu)订《办(ban)(ban)法》不再(zai)单(dan)设审(shen)(shen)批(pi)结(jie)(jie)束(shu)后(hou)的(de)(de)复审(shen)(shen)程序，而是(shi)将复审(shen)(shen)工作的(de)(de)实质内容(rong)前置到审(shen)(shen)评(ping)结(jie)(jie)束(shu)前，对(dui)审(shen)(shen)评(ping)结(jie)(jie)论有异(yi)议的(de)(de)，申请(qing)人(ren)可以(yi)在审(shen)(shen)评(ping)阶段提(ti)出，将异(yi)议问题(ti)尽早在前端(duan)解决。二是(shi)审(shen)(shen)批(pi)结(jie)(jie)束(shu)后(hou)，申请(qing)人(ren)仍有异(yi)议的(de)(de)，可以(yi)采取(qu)行政复议和行政诉讼等手段维护权益。
十九、《办(ban)法(fa)》有哪些相关文件和工作？
《办法》发(fa)(fa)布(bu)后(hou)有多项需要(yao)(yao)(yao)配(pei)套开展(zhan)的(de)(de)(de)工作(zuo)和(he)发(fa)(fa)布(bu)的(de)(de)(de)文件(jian)，同时还(hai)要(yao)(yao)(yao)根据工作(zuo)需要(yao)(yao)(yao)补(bu)充增加(jia)，与之配(pei)套的(de)(de)(de)规范性(xing)文件(jian)和(he)技术(shu)指导(dao)原(yuan)则(ze)等(deng)正在加(jia)快制(zhi)(zhi)修(xiu)订。目前正在重点推进(jin)中(zhong)药(yao)(yao)、化学药(yao)(yao)和(he)生物制(zhi)(zhi)品的(de)(de)(de)注册分类(lei)(lei)及申(shen)报资料(liao)(liao)要(yao)(yao)(yao)求(qiu)(qiu)、变更分类(lei)(lei)及申(shen)报资料(liao)(liao)要(yao)(yao)(yao)求(qiu)(qiu)、再注册申(shen)报资料(liao)(liao)要(yao)(yao)(yao)求(qiu)(qiu)、持有人(ren)变更上市许可等(deng)配(pei)套文件(jian)，将(jiang)按照成熟(shu)一个发(fa)(fa)布(bu)一个的(de)(de)(de)原(yuan)则(ze)，陆(lu)续发(fa)(fa)布(bu)实施。后(hou)续，将(jiang)进(jin)一步丰富技术(shu)指导(dao)原(yuan)则(ze)体(ti)系，提升技术(shu)指导(dao)原(yuan)则(ze)体(ti)系的(de)(de)(de)全面性(xing)和(he)系统性(xing)，既为审(shen)(shen)评(ping)审(shen)(shen)批(pi)、核查检验提供技术(shu)参考(kao)，又为支(zhi)持行业发(fa)(fa)展(zhan)、鼓励创(chuang)新提供引导(dao)。
