一、《办法》修订的背(bei)景是什(shen)么？
药(yao)品与人民群众健康息息相关(guan)(guan)，党中央、国(guo)务院高(gao)度(du)(du)重(zhong)视。2015年以(yi)来，先(xian)(xian)后印发(fa)《国(guo)务院关(guan)(guan)于(yu)(yu)改革(ge)药(yao)品医疗(liao)器(qi)(qi)械(xie)审(shen)(shen)评(ping)审(shen)(shen)批制(zhi)度(du)(du)的意见》（国(guo)发(fa)〔2015〕44号(hao)，以(yi)下(xia)简(jian)称(cheng)44号(hao)文件）、《关(guan)(guan)于(yu)(yu)深化审(shen)(shen)评(ping)审(shen)(shen)批制(zhi)度(du)(du)改革(ge)鼓励药(yao)品医疗(liao)器(qi)(qi)械(xie)创新的意见》（厅字(zi)〔2017〕42号(hao)，以(yi)下(xia)简(jian)称(cheng)42号(hao)文件）等重(zhong)要(yao)文件，部署推进(jin)药(yao)品上(shang)市许(xu)(xu)可(ke)(ke)持有人制(zhi)度(du)(du)试点、药(yao)物临床试验默示许(xu)(xu)可(ke)(ke)、关(guan)(guan)联审(shen)(shen)评(ping)审(shen)(shen)批、优(you)先(xian)(xian)审(shen)(shen)评(ping)审(shen)(shen)批等一(yi)系列(lie)改革(ge)举措。2019年6月(yue)和8月(yue)，全(quan)国(guo)人大常委会(hui)先(xian)(xian)后审(shen)(shen)议(yi)通(tong)过《疫苗(miao)管(guan)(guan)理法》和新修订的《药(yao)品管(guan)(guan)理法》，于(yu)(yu)12月(yue)1日起施行(xing)(xing)。两部法律全(quan)面(mian)实施药(yao)品上(shang)市许(xu)(xu)可(ke)(ke)持有人制(zhi)度(du)(du)，建立药(yao)物临床试验默示许(xu)(xu)可(ke)(ke)、附(fu)条件批准、优(you)先(xian)(xian)审(shen)(shen)评(ping)审(shen)(shen)批、上(shang)市后变更分类管(guan)(guan)理等一(yi)系列(lie)管(guan)(guan)理制(zhi)度(du)(du)，并(bing)要(yao)求完善药(yao)品审(shen)(shen)评(ping)审(shen)(shen)批工(gong)作(zuo)制(zhi)度(du)(du)，优(you)化审(shen)(shen)评(ping)审(shen)(shen)批流程，提高(gao)审(shen)(shen)评(ping)审(shen)(shen)批效率。现行(xing)(xing)《办法》颁(ban)布于(yu)(yu)2007年，在保(bao)证药(yao)品的安(an)全(quan)、有效和质量(liang)可(ke)(ke)控以(yi)及(ji)规(gui)范药(yao)品注册行(xing)(xing)为等方面(mian)发(fa)挥了重(zhong)要(yao)作(zuo)用，但(dan)已不适应新制(zhi)修订法律、药(yao)品审(shen)(shen)评(ping)审(shen)(shen)批制(zhi)度(du)(du)改革(ge)的要(yao)求以(yi)及(ji)科学进(jin)步和医药(yao)行(xing)(xing)业快速发(fa)展的需(xu)要(yao)，有必要(yao)进(jin)行(xing)(xing)全(quan)面(mian)修订。
二、《办(ban)法》修(xiu)订的思路是什么？
这次(ci)修订《办法(fa)》，坚持贯彻新(xin)制修订法(fa)律(lv)要求(qiu)，吸纳(na)药品(pin)(pin)(pin)(pin)审评审批制度改革(ge)成果围绕明确药品(pin)(pin)(pin)(pin)注册(ce)管(guan)理(li)工作(zuo)的(de)(de)基本要求(qiu)，对药品(pin)(pin)(pin)(pin)注册(ce)的(de)(de)基本制度、基本原(yuan)则、基本程序和各方主要责任义务(wu)等(deng)作(zuo)出(chu)规(gui)定，突出(chu)《办法(fa)》的(de)(de)管(guan)理(li)属性。考虑到药品(pin)(pin)(pin)(pin)注册(ce)管(guan)理(li)中(zhong)的(de)(de)具(ju)体技术要求(qiu)将(jiang)结(jie)合(he)技术发(fa)展不断(duan)调整完善，在规(gui)章(zhang)中(zhong)不宜作(zuo)具(ju)体规(gui)定，后(hou)续将(jiang)以配套文(wen)件(jian)、技术指导原(yuan)则等(deng)形式发(fa)布，更好地体现药品(pin)(pin)(pin)(pin)研发(fa)的(de)(de)科学(xue)规(gui)律(lv)。
三、如何加强全生命周(zhou)期管理？
这次修订《办(ban)法(fa)(fa)》，在药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)监(jian)(jian)(jian)管(guan)(guan)(guan)理(li)(li)念(nian)方面创新(xin)，引(yin)入药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)全生(sheng)(sheng)命(ming)(ming)周(zhou)期(qi)管(guan)(guan)(guan)理(li)(li)理(li)(li)念(nian)，系统进(jin)(jin)行设(she)计(ji)，加(jia)(jia)强从药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)研(yan)制(zhi)上(shang)(shang)(shang)市(shi)、上(shang)(shang)(shang)市(shi)后(hou)管(guan)(guan)(guan)理(li)(li)到药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)册(ce)证书(shu)注(zhu)(zhu)销等各(ge)环(huan)(huan)(huan)节(jie)(jie)(jie)全过程、全链条(tiao)的(de)监(jian)(jian)(jian)管(guan)(guan)(guan)制(zhi)度：一(yi)是(shi)(shi)增加(jia)(jia)GLP机(ji)构、GCP机(ji)构监(jian)(jian)(jian)督(du)(du)检(jian)查(cha)相(xiang)(xiang)(xiang)关(guan)(guan)(guan)内(nei)容，强化省(sheng)级药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)监(jian)(jian)(jian)督(du)(du)管(guan)(guan)(guan)理(li)(li)部门的(de)日常监(jian)(jian)(jian)管(guan)(guan)(guan)事权(quan)，充分发挥省(sheng)级药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)监(jian)(jian)(jian)督(du)(du)管(guan)(guan)(guan)理(li)(li)部门监(jian)(jian)(jian)管(guan)(guan)(guan)作(zuo)用(yong)(yong)，保(bao)障GLP、GCP持(chi)续(xu)(xu)合规(gui)(gui)(gui)和(he)(he)(he)工(gong)(gong)作(zuo)质量。二是(shi)(shi)明确(que)附条(tiao)件批准(zhun)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)市(shi)后(hou)必须完(wan)成相(xiang)(xiang)(xiang)应(ying)(ying)工(gong)(gong)作(zuo)的(de)时限要求(qiu)(qiu)(qiu)，对(dui)未按时限要求(qiu)(qiu)(qiu)完(wan)成的(de)，明确(que)相(xiang)(xiang)(xiang)应(ying)(ying)处(chu)(chu)理(li)(li)措(cuo)施(shi)，直至撤(che)销药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)册(ce)证书(shu)。三是(shi)(shi)增设(she)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)市(shi)后(hou)变(bian)更和(he)(he)(he)再注(zhu)(zhu)册(ce)一(yi)章(zhang)，充分体现新(xin)修订《药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)管(guan)(guan)(guan)理(li)(li)法(fa)(fa)》的(de)要求(qiu)(qiu)(qiu)，强化药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)市(shi)后(hou)研(yan)究和(he)(he)(he)变(bian)更管(guan)(guan)(guan)理(li)(li)相(xiang)(xiang)(xiang)关(guan)(guan)(guan)要求(qiu)(qiu)(qiu)，要求(qiu)(qiu)(qiu)持(chi)有人(ren)(ren)(ren)主动开展药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)市(shi)后(hou)研(yan)究，对(dui)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)的(de)安(an)(an)全性(xing)、有效(xiao)性(xing)和(he)(he)(he)质量可(ke)控性(xing)进(jin)(jin)行进(jin)(jin)一(yi)步确(que)证，加(jia)(jia)强对(dui)已上(shang)(shang)(shang)市(shi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)的(de)持(chi)续(xu)(xu)管(guan)(guan)(guan)理(li)(li)，明确(que)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)市(shi)后(hou)变(bian)更分类及申报(bao)(bao)、备(bei)案和(he)(he)(he)报(bao)(bao)告途(tu)径，体现药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)全生(sheng)(sheng)命(ming)(ming)周(zhou)期(qi)管(guan)(guan)(guan)理(li)(li)。四是(shi)(shi)采用(yong)(yong)信(xin)息(xi)化手(shou)段强化药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)册(ce)管(guan)(guan)(guan)理(li)(li)，建立药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)品(pin)(pin)(pin)(pin)(pin)(pin)种档(dang)案，为(wei)(wei)实现药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)全生(sheng)(sheng)命(ming)(ming)周(zhou)期(qi)的(de)日常监(jian)(jian)(jian)管(guan)(guan)(guan)和(he)(he)(he)各(ge)监(jian)(jian)(jian)管(guan)(guan)(guan)环(huan)(huan)(huan)节(jie)(jie)(jie)信(xin)息(xi)无缝(feng)衔接奠定(ding)基础。增加(jia)(jia)对(dui)GLP机(ji)构、GCP机(ji)构的(de)监(jian)(jian)(jian)管(guan)(guan)(guan)以(yi)(yi)及药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)安(an)(an)全信(xin)用(yong)(yong)档(dang)案的(de)相(xiang)(xiang)(xiang)关(guan)(guan)(guan)要求(qiu)(qiu)(qiu)。增加(jia)(jia)信(xin)息(xi)公(gong)开内(nei)容，公(gong)开审评结论和(he)(he)(he)依据，接受社会监(jian)(jian)(jian)督(du)(du)，促进(jin)(jin)社会共(gong)治；将药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)说明书(shu)列为(wei)(wei)信(xin)息(xi)公(gong)开内(nei)容并(bing)(bing)适时更新(xin)，为(wei)(wei)公(gong)众查(cha)询使用(yong)(yong)提(ti)供方便。五是(shi)(shi)根据规(gui)(gui)(gui)章(zhang)权(quan)限，对(dui)法(fa)(fa)律规(gui)(gui)(gui)定(ding)应(ying)(ying)予处(chu)(chu)罚情形予以(yi)(yi)适当(dang)细化，强化对(dui)监(jian)(jian)(jian)管(guan)(guan)(guan)人(ren)(ren)(ren)员(yuan)的(de)责任(ren)(ren)(ren)追究，严厉打击研(yan)制(zhi)环(huan)(huan)(huan)节(jie)(jie)(jie)数(shu)据造假等违法(fa)(fa)违规(gui)(gui)(gui)行为(wei)(wei)，营(ying)造鼓励创新(xin)的(de)良好(hao)环(huan)(huan)(huan)境。六是(shi)(shi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)上(shang)(shang)(shang)市(shi)许(xu)可(ke)申请人(ren)(ren)(ren)（持(chi)有人(ren)(ren)(ren)）的(de)质量管(guan)(guan)(guan)理(li)(li)、风(feng)险防控和(he)(he)(he)责任(ren)(ren)(ren)赔偿等能(neng)力(li)的(de)建立和(he)(he)(he)完(wan)善(shan)，贯穿(chuan)于(yu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)全生(sheng)(sheng)命(ming)(ming)周(zhou)期(qi)各(ge)环(huan)(huan)(huan)节(jie)(jie)(jie)，药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)注(zhu)(zhu)册(ce)环(huan)(huan)(huan)节(jie)(jie)(jie)综合体现在其对(dui)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)的(de)非临(lin)床研(yan)究、临(lin)床试验、药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)试制(zhi)和(he)(he)(he)生(sheng)(sheng)产(chan)、上(shang)(shang)(shang)市(shi)前检(jian)查(cha)核查(cha)、上(shang)(shang)(shang)市(shi)后(hou)研(yan)究、不良反(fan)应(ying)(ying)报(bao)(bao)告与(yu)处(chu)(chu)理(li)(li)以(yi)(yi)及药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)生(sheng)(sheng)产(chan)和(he)(he)(he)上(shang)(shang)(shang)市(shi)许(xu)可(ke)等符合相(xiang)(xiang)(xiang)应(ying)(ying)的(de)管(guan)(guan)(guan)理(li)(li)规(gui)(gui)(gui)范、标准(zhun)和(he)(he)(he)要求(qiu)(qiu)(qiu)；申请人(ren)(ren)(ren)（持(chi)有人(ren)(ren)(ren)）应(ying)(ying)当(dang)持(chi)续(xu)(xu)加(jia)(jia)强对(dui)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)(pin)全生(sheng)(sheng)命(ming)(ming)周(zhou)期(qi)的(de)管(guan)(guan)(guan)理(li)(li)，并(bing)(bing)依法(fa)(fa)承(cheng)担主体责任(ren)(ren)(ren)。
四、如何贯(guan)彻“放管(guan)服”改革要求？
这次(ci)修订《办(ban)法》，按(an)照国务院简政放权和(he)“放管(guan)(guan)(guan)(guan)(guan)服”要(yao)求，创新药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)(zhu)册(ce)管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)方式：一(yi)是(shi)建立关(guan)(guan)(guan)(guan)联(lian)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批制(zhi)(zhi)度(du)(du)，根据新修订《药(yao)(yao)(yao)(yao)品(pin)(pin)管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)法》规定，化(hua)(hua)学(xue)原(yuan)(yuan)料(liao)(liao)药(yao)(yao)(yao)(yao)按(an)照药(yao)(yao)(yao)(yao)品(pin)(pin)管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)，实行(xing)(xing)(xing)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批准入制(zhi)(zhi)度(du)(du)。化(hua)(hua)学(xue)原(yuan)(yuan)料(liao)(liao)药(yao)(yao)(yao)(yao)生(sheng)(sheng)(sheng)产(chan)(chan)企(qi)(qi)业应当按(an)照《国家药(yao)(yao)(yao)(yao)监局关(guan)(guan)(guan)(guan)于(yu)进一(yi)步(bu)(bu)完善药(yao)(yao)(yao)(yao)品(pin)(pin)关(guan)(guan)(guan)(guan)联(lian)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批和(he)监管(guan)(guan)(guan)(guan)(guan)工作(zuo)有关(guan)(guan)(guan)(guan)事宜的(de)(de)公告(gao)》（2019年第56号）的(de)(de)要(yao)求在(zai)(zai)“原(yuan)(yuan)辅(fu)包(bao)登(deng)(deng)(deng)记平台(tai)”进行(xing)(xing)(xing)登(deng)(deng)(deng)记，并按(an)照有关(guan)(guan)(guan)(guan)登(deng)(deng)(deng)记要(yao)求提交技术资料(liao)(liao)，明(ming)确生(sheng)(sheng)(sheng)产(chan)(chan)场地地址等(deng)信息。药(yao)(yao)(yao)(yao)品(pin)(pin)制(zhi)(zhi)剂(ji)申(shen)(shen)请(qing)(qing)人(ren)(ren)自行(xing)(xing)(xing)生(sheng)(sheng)(sheng)产(chan)(chan)化(hua)(hua)学(xue)原(yuan)(yuan)料(liao)(liao)药(yao)(yao)(yao)(yao)的(de)(de)，由药(yao)(yao)(yao)(yao)品(pin)(pin)制(zhi)(zhi)剂(ji)申(shen)(shen)请(qing)(qing)人(ren)(ren)在(zai)(zai)“原(yuan)(yuan)辅(fu)包(bao)登(deng)(deng)(deng)记平台(tai)”登(deng)(deng)(deng)记，在(zai)(zai)提出药(yao)(yao)(yao)(yao)品(pin)(pin)制(zhi)(zhi)剂(ji)注(zhu)(zhu)(zhu)(zhu)册(ce)申(shen)(shen)请(qing)(qing)时(shi)(shi)与其(qi)进行(xing)(xing)(xing)关(guan)(guan)(guan)(guan)联(lian)；选择其(qi)他化(hua)(hua)学(xue)原(yuan)(yuan)料(liao)(liao)药(yao)(yao)(yao)(yao)生(sheng)(sheng)(sheng)产(chan)(chan)企(qi)(qi)业的(de)(de)，由化(hua)(hua)学(xue)原(yuan)(yuan)料(liao)(liao)药(yao)(yao)(yao)(yao)生(sheng)(sheng)(sheng)产(chan)(chan)企(qi)(qi)业在(zai)(zai)“原(yuan)(yuan)辅(fu)包(bao)登(deng)(deng)(deng)记平台(tai)”登(deng)(deng)(deng)记，药(yao)(yao)(yao)(yao)品(pin)(pin)制(zhi)(zhi)剂(ji)申(shen)(shen)请(qing)(qing)人(ren)(ren)在(zai)(zai)提出药(yao)(yao)(yao)(yao)品(pin)(pin)制(zhi)(zhi)剂(ji)注(zhu)(zhu)(zhu)(zhu)册(ce)申(shen)(shen)请(qing)(qing)时(shi)(shi)与其(qi)进行(xing)(xing)(xing)关(guan)(guan)(guan)(guan)联(lian)。取消(xiao)辅(fu)料(liao)(liao)及直(zhi)接(jie)(jie)接(jie)(jie)触(chu)(chu)药(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)包(bao)装材(cai)料(liao)(liao)和(he)容器的(de)(de)单(dan)独审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批事项，在(zai)(zai)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批制(zhi)(zhi)剂(ji)时(shi)(shi)一(yi)并审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)，减少审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批事项，提高审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批效率的(de)(de)同时(shi)(shi)，更(geng)(geng)(geng)加突出药(yao)(yao)(yao)(yao)品(pin)(pin)制(zhi)(zhi)剂(ji)持有人(ren)(ren)对(dui)辅(fu)料(liao)(liao)及直(zhi)接(jie)(jie)接(jie)(jie)触(chu)(chu)药(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)包(bao)装材(cai)料(liao)(liao)和(he)容器的(de)(de)管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)责任和(he)主体地位(wei)。二是(shi)药(yao)(yao)(yao)(yao)物临床试验(yan)(yan)(yan)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批实施(shi)默示许(xu)可制(zhi)(zhi)度(du)(du)，生(sheng)(sheng)(sheng)物等(deng)效性试验(yan)(yan)(yan)由原(yuan)(yuan)来(lai)的(de)(de)许(xu)可制(zhi)(zhi)度(du)(du)改(gai)为(wei)备(bei)案(an)制(zhi)(zhi)度(du)(du)。三是(shi)对(dui)药(yao)(yao)(yao)(yao)品(pin)(pin)变(bian)更(geng)(geng)(geng)实行(xing)(xing)(xing)分类管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)，中等(deng)程度(du)(du)变(bian)更(geng)(geng)(geng)由省级药(yao)(yao)(yao)(yao)品(pin)(pin)监督管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)部门实施(shi)备(bei)案(an)管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)，微(wei)小程度(du)(du)变(bian)更(geng)(geng)(geng)实施(shi)企(qi)(qi)业年度(du)(du)报告(gao)管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)，同时(shi)(shi)也进一(yi)步(bu)(bu)明(ming)确了场地变(bian)更(geng)(geng)(geng)和(he)工艺变(bian)更(geng)(geng)(geng)的(de)(de)管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)职责。四是(shi)依据产(chan)(chan)品(pin)(pin)创新程度(du)(du)和(he)风(feng)险(xian)特点(dian)，实行(xing)(xing)(xing)基于(yu)风(feng)险(xian)的(de)(de)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)、核(he)查(cha)和(he)检(jian)验(yan)(yan)(yan)模(mo)式，明(ming)确必须进行(xing)(xing)(xing)药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)(zhu)册(ce)现场核(he)查(cha)的(de)(de)情形，允许(xu)同步(bu)(bu)进行(xing)(xing)(xing)药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)(zhu)册(ce)现场核(he)查(cha)和(he)上(shang)市前(qian)药(yao)(yao)(yao)(yao)品(pin)(pin)生(sheng)(sheng)(sheng)产(chan)(chan)质量(liang)管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)规范检(jian)查(cha)，提高审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批工作(zuo)效率。五是(shi)科学(xue)设置(zhi)药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)(zhu)册(ce)检(jian)验(yan)(yan)(yan)流(liu)程，将药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)(zhu)册(ce)检(jian)验(yan)(yan)(yan)调整为(wei)可于(yu)受(shou)理(li)(li)(li)前(qian)启动，申(shen)(shen)请(qing)(qing)人(ren)(ren)可以选择在(zai)(zai)申(shen)(shen)请(qing)(qing)人(ren)(ren)或者(zhe)生(sheng)(sheng)(sheng)产(chan)(chan)企(qi)(qi)业所在(zai)(zai)地药(yao)(yao)(yao)(yao)品(pin)(pin)检(jian)验(yan)(yan)(yan)机构进行(xing)(xing)(xing)检(jian)验(yan)(yan)(yan)。六是(shi)强(qiang)(qiang)化(hua)(hua)事中事后监管(guan)(guan)(guan)(guan)(guan)，强(qiang)(qiang)调研(yan)制(zhi)(zhi)行(xing)(xing)(xing)为(wei)持续合规，严格上(shang)市后研(yan)究管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)要(yao)求，加强(qiang)(qiang)信息公开(kai)和(he)社(she)会监督，强(qiang)(qiang)化(hua)(hua)药(yao)(yao)(yao)(yao)品(pin)(pin)全生(sheng)(sheng)(sheng)命周(zhou)期管(guan)(guan)(guan)(guan)(guan)理(li)(li)(li)。
五、如何(he)持续(xu)推进药品(pin)审(shen)评审(shen)批(pi)制(zhi)度改革(ge)？
这次修(xiu)订(ding)(ding)《办(ban)法》，既(ji)体(ti)现、固(gu)(gu)化(hua)药品领(ling)域改(gai)(gai)革(ge)(ge)的(de)成果，又将引领(ling)、推(tui)(tui)动(dong)改(gai)(gai)革(ge)(ge)持续(xu)、全面深化(hua)：一是固(gu)(gu)化(hua)药品审(shen)评(ping)(ping)(ping)审(shen)批(pi)(pi)制(zhi)(zhi)度改(gai)(gai)革(ge)(ge)成果。坚决落实党(dang)中央(yang)、国务院改(gai)(gai)革(ge)(ge)部(bu)署(shu)和新制(zhi)(zhi)修(xiu)订(ding)(ding)法律精神，巩固(gu)(gu)42号(hao)文件、44号(hao)文件部(bu)署(shu)的(de)改(gai)(gai)革(ge)(ge)成果。实践证明行之有效的(de)改(gai)(gai)革(ge)(ge)措施，及时在部(bu)门规章中体(ti)现，能够为(wei)审(shen)评(ping)(ping)(ping)审(shen)批(pi)(pi)制(zhi)(zhi)度改(gai)(gai)革(ge)(ge)提供强(qiang)有力的(de)保障。二(er)是持续(xu)推(tui)(tui)进审(shen)评(ping)(ping)(ping)审(shen)批(pi)(pi)制(zhi)(zhi)度改(gai)(gai)革(ge)(ge)。按照《办(ban)法》修(xiu)订(ding)(ding)的(de)总体(ti)思路(lu)，《办(ban)法》正文做原则性表述，为(wei)将来(lai)的(de)继续(xu)深化(hua)改(gai)(gai)革(ge)(ge)留有空间。根据新修(xiu)订(ding)(ding)《办(ban)法》，国家局将持续(xu)推(tui)(tui)进审(shen)评(ping)(ping)(ping)审(shen)批(pi)(pi)制(zhi)(zhi)度改(gai)(gai)革(ge)(ge)，优化(hua)审(shen)评(ping)(ping)(ping)审(shen)批(pi)(pi)流程，提高审(shen)评(ping)(ping)(ping)审(shen)批(pi)(pi)效率，建立以审(shen)评(ping)(ping)(ping)为(wei)主导(dao)，检(jian)验、核(he)查、监测与(yu)评(ping)(ping)(ping)价等为(wei)支撑(cheng)的(de)药品注册管(guan)理体(ti)系。
六、引入了哪(na)些(xie)新的理念和制度？
这次修订《办法(fa)》，与2007版《办法(fa)》相比(bi)，引入(ru)了(le)许(xu)多新(xin)(xin)的(de)(de)理(li)念和制度(du)设(she)计：一是(shi)固化(hua)(hua)了(le)近些年药(yao)(yao)品(pin)审(shen)评审(shen)批(pi)制度(du)改(gai)(gai)革推出的(de)(de)新(xin)(xin)的(de)(de)改(gai)(gai)革举措，将药(yao)(yao)品(pin)监管中一些比(bi)较核(he)(he)心的(de)(de)新(xin)(xin)制度(du)在(zai)新(xin)(xin)修订《办法(fa)》中体(ti)现。比(bi)如药(yao)(yao)品(pin)上(shang)市(shi)许(xu)可(ke)持有(you)人(ren)制度(du)、药(yao)(yao)物临床试验默示(shi)许(xu)可(ke)、优先审(shen)评审(shen)批(pi)、原辅包和制剂关联审(shen)评审(shen)批(pi)、沟通(tong)交流、专家咨询等新(xin)(xin)制度(du)。二是(shi)进一步(bu)优化(hua)(hua)审(shen)评审(shen)批(pi)程序。比(bi)如药(yao)(yao)品(pin)注册检(jian)验可(ke)以在(zai)受(shou)理(li)前启动、药(yao)(yao)品(pin)注册现场核(he)(he)查(cha)和上(shang)市(shi)前药(yao)(yao)品(pin)生产质(zhi)量管理(li)规范检(jian)查(cha)同步(bu)实施等新(xin)(xin)理(li)念。
七(qi)、有哪些鼓励(li)药(yao)物研(yan)制和创新(xin)的新(xin)举(ju)措(cuo)？
创(chuang)新(xin)是推动药(yao)品(pin)高质量发(fa)展(zhan)的(de)(de)力量源泉。这次(ci)修订(ding)《办法》，充实了鼓(gu)励药(yao)物研制和(he)创(chuang)新(xin)的(de)(de)内容，以(yi)提高药(yao)品(pin)可及性(xing)：一是结(jie)合(he)我国医药(yao)产业(ye)发(fa)展(zhan)和(he)临(lin)床(chuang)(chuang)治疗需(xu)(xu)求实际(ji)，参考(kao)国际(ji)经(jing)验(yan)，增设药(yao)品(pin)加快(kuai)上市注册(ce)程(cheng)序一章，设立(li)突破性(xing)治疗药(yao)物、附条件批准、优先审(shen)评审(shen)批、特别(bie)审(shen)批四(si)个加快(kuai)通道(dao)，并明确每(mei)个通道(dao)的(de)(de)纳(na)入范围(wei)、程(cheng)序、支持政策等要求。二(er)是将《药(yao)品(pin)管理(li)法》《疫(yi)苗(miao)管理(li)法》及国务(wu)院文(wen)件中(zhong)列(lie)明的(de)(de)临(lin)床(chuang)(chuang)急(ji)需(xu)(xu)的(de)(de)短缺药(yao)、儿童用(yong)药(yao)、罕见(jian)病用(yong)药(yao)、重大传(chuan)染病用(yong)药(yao)、疾病防控(kong)急(ji)需(xu)(xu)疫(yi)苗(miao)和(he)创(chuang)新(xin)疫(yi)苗(miao)等均(jun)明确纳(na)入加快(kuai)上市注册(ce)范围(wei)。
八、如何体(ti)现药物研(yan)制和注册规律？
这次(ci)修订《办法》，更加(jia)注(zhu)重药(yao)(yao)物(wu)(wu)研制(zhi)(zhi)(zhi)和注(zhu)册(ce)管(guan)理(li)的(de)(de)科学规律：一是(shi)将沟通(tong)(tong)交(jiao)流(liu)制(zhi)(zhi)(zhi)度纳入药(yao)(yao)品注(zhu)册(ce)管(guan)理(li)的(de)(de)基(ji)本制(zhi)(zhi)(zhi)度。良(liang)好(hao)的(de)(de)沟通(tong)(tong)交(jiao)流(liu)是(shi)提高审(shen)(shen)(shen)评审(shen)(shen)(shen)批质量和效率的(de)(de)基(ji)础(chu)。一方(fang)面，申(shen)请(qing)人在药(yao)(yao)物(wu)(wu)临(lin)床(chuang)(chuang)试(shi)验(yan)申(shen)请(qing)前(qian)、药(yao)(yao)物(wu)(wu)临(lin)床(chuang)(chuang)试(shi)验(yan)过程中(zhong)(zhong)以(yi)及药(yao)(yao)品上(shang)市(shi)许(xu)(xu)可(ke)申(shen)请(qing)前(qian)等(deng)(deng)关键阶段(duan)，可(ke)以(yi)就重大问题与(yu)药(yao)(yao)品审(shen)(shen)(shen)评中(zhong)(zhong)心(xin)等(deng)(deng)专(zhuan)业(ye)技术机构(gou)进(jin)(jin)行沟通(tong)(tong)交(jiao)流(liu)；另一方(fang)面，药(yao)(yao)品注(zhu)册(ce)过程中(zhong)(zhong)，药(yao)(yao)品审(shen)(shen)(shen)评中(zhong)(zhong)心(xin)等(deng)(deng)专(zhuan)业(ye)技术机构(gou)可(ke)以(yi)根据工(gong)作需要组织与(yu)申(shen)请(qing)人进(jin)(jin)行沟通(tong)(tong)交(jiao)流(liu)。二是(shi)建(jian)立(li)了(le)(le)(le)符合药(yao)(yao)物(wu)(wu)临(lin)床(chuang)(chuang)试(shi)验(yan)特点的(de)(de)管(guan)理(li)制(zhi)(zhi)(zhi)度。比如对药(yao)(yao)物(wu)(wu)临(lin)床(chuang)(chuang)试(shi)验(yan)实施默示许(xu)(xu)可(ke)，生物(wu)(wu)等(deng)(deng)效性试(shi)验(yan)实施备案(an)；从(cong)对受试(shi)者安(an)全的(de)(de)保护角度，明确了(le)(le)(le)药(yao)(yao)物(wu)(wu)临(lin)床(chuang)(chuang)试(shi)验(yan)期间变(bian)更的(de)(de)管(guan)理(li)和申(shen)报(bao)路(lu)径等(deng)(deng)。三是(shi)建(jian)立(li)了(le)(le)(le)更加(jia)符合药(yao)(yao)物(wu)(wu)研制(zhi)(zhi)(zhi)和监(jian)管(guan)实践的(de)(de)上(shang)市(shi)许(xu)(xu)可(ke)和上(shang)市(shi)后(hou)变(bian)更管(guan)理(li)制(zhi)(zhi)(zhi)度。药(yao)(yao)品上(shang)市(shi)许(xu)(xu)可(ke)有完整路(lu)径、直接申(shen)报(bao)上(shang)市(shi)路(lu)径和非处方(fang)药(yao)(yao)路(lu)径，优化了(le)(le)(le)申(shen)报(bao)和审(shen)(shen)(shen)批程序。药(yao)(yao)品上(shang)市(shi)后(hou)变(bian)更按照(zhao)审(shen)(shen)(shen)批、备案(an)和报(bao)告事项(xiang)进(jin)(jin)行分类管(guan)理(li)。
九、如(ru)何鼓励中药传承(cheng)和(he)创新？
支持中(zhong)药(yao)(yao)(yao)传(chuan)承和(he)创新，一直是药(yao)(yao)(yao)品监管(guan)工作的(de)(de)重(zhong)要(yao)内容。为(wei)突出中(zhong)药(yao)(yao)(yao)优(you)势(shi)，充(chong)分考虑中(zhong)药(yao)(yao)(yao)特点(dian)(dian)，这次(ci)修订《办法》明确国家鼓励运(yun)用现代科学技术和(he)传(chuan)统研究方法研制中(zhong)药(yao)(yao)(yao)，建立和(he)完善中(zhong)药(yao)(yao)(yao)特点(dian)(dian)的(de)(de)注册(ce)分类和(he)技术评价体系，促进中(zhong)药(yao)(yao)(yao)传(chuan)承创新，同时注重(zhong)对(dui)中(zhong)药(yao)(yao)(yao)资(zi)源的(de)(de)保护(hu)，促进资(zi)源可持续(xu)利用。后续(xu),将制定(ding)中(zhong)药(yao)(yao)(yao)注册(ce)管(guan)理的(de)(de)专门规定(ding)，更好地促进中(zhong)药(yao)(yao)(yao)产业高质量发展(zhan)。
十、药物临(lin)床(chuang)试验管理进行了哪些(xie)优化和强化？
这次(ci)修订《办法》，对药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)的(de)(de)许可(ke)备(bei)案(an)以及药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)过程的(de)(de)管理进行(xing)细化(hua)和优化(hua)：一(yi)是(shi)药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)申(shen)(shen)(shen)(shen)请自(zi)受(shou)理之(zhi)(zhi)日起(qi)六十日内(nei)决定(ding)是(shi)否(fou)同(tong)(tong)(tong)意开(kai)(kai)(kai)展(zhan)(zhan)，并通(tong)(tong)过药(yao)(yao)品审评中心(xin)网站通(tong)(tong)知申(shen)(shen)(shen)(shen)请人审批结(jie)果；逾期(qi)未通(tong)(tong)知的(de)(de)，视为同(tong)(tong)(tong)意，申(shen)(shen)(shen)(shen)请人可(ke)以按(an)照提(ti)交(jiao)的(de)(de)方案(an)开(kai)(kai)(kai)展(zhan)(zhan)药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)。申(shen)(shen)(shen)(shen)请人拟开(kai)(kai)(kai)展(zhan)(zhan)生(sheng)物(wu)(wu)(wu)(wu)等效(xiao)性试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)的(de)(de)，在完成生(sheng)物(wu)(wu)(wu)(wu)等效(xiao)性试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)备(bei)案(an)后，按(an)照备(bei)案(an)的(de)(de)方案(an)开(kai)(kai)(kai)展(zhan)(zhan)相(xiang)关研究工作。二(er)是(shi)强化(hua)了(le)(le)药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)的(de)(de)过程管理。在药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)期(qi)间(jian)，申(shen)(shen)(shen)(shen)办者(zhe)(zhe)(zhe)应(ying)(ying)当定(ding)期(qi)提(ti)交(jiao)研发期(qi)间(jian)安(an)全性更(geng)新报(bao)告、报(bao)告药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)期(qi)间(jian)出(chu)现的(de)(de)可(ke)疑且(qie)非预期(qi)严(yan)重不良(liang)反(fan)应(ying)(ying)和其(qi)他潜在的(de)(de)严(yan)重安(an)全性风(feng)险(xian)(xian)信息(xi)。根(gen)据安(an)全性风(feng)险(xian)(xian)严(yan)重程度(du)，可(ke)以要求(qiu)(qiu)申(shen)(shen)(shen)(shen)办者(zhe)(zhe)(zhe)采取调整药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)方案(an)、知情(qing)同(tong)(tong)(tong)意书、研究者(zhe)(zhe)(zhe)手册等加强风(feng)险(xian)(xian)控制的(de)(de)措施(shi)，必要时(shi)可(ke)以要求(qiu)(qiu)申(shen)(shen)(shen)(shen)办者(zhe)(zhe)(zhe)暂停(ting)或者(zhe)(zhe)(zhe)终止药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)。三是(shi)新增了(le)(le)药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)变更(geng)的(de)(de)路径(jing)。药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)期(qi)间(jian)发生(sheng)的(de)(de)变更(geng)，根(gen)据对受(shou)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)者(zhe)(zhe)(zhe)安(an)全的(de)(de)影响进行(xing)相(xiang)应(ying)(ying)的(de)(de)申(shen)(shen)(shen)(shen)报(bao)或者(zhe)(zhe)(zhe)报(bao)告。四是(shi)明确了(le)(le)药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)实施(shi)的(de)(de)标准。明确了(le)(le)药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)申(shen)(shen)(shen)(shen)请自(zi)获准之(zhi)(zhi)日起(qi)，三年(nian)内(nei)未有受(shou)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)者(zhe)(zhe)(zhe)签署知情(qing)同(tong)(tong)(tong)意书的(de)(de)，该药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)许可(ke)自(zi)行(xing)失效(xiao)。提(ti)出(chu)了(le)(le)药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)登记的(de)(de)要求(qiu)(qiu)。五是(shi)在法律(lv)责(ze)任中增加了(le)(le)未按(an)规定(ding)开(kai)(kai)(kai)展(zhan)(zhan)药(yao)(yao)物(wu)(wu)(wu)(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)(shi)(shi)(shi)(shi)验(yan)(yan)(yan)(yan)(yan)情(qing)况的(de)(de)相(xiang)应(ying)(ying)罚(fa)则(ze)。
十一、药品(pin)上市许(xu)可路径进(jin)行了哪些优化？
《办法》明确了三(san)(san)种申(shen)(shen)请(qing)药(yao)(yao)品上(shang)市(shi)许可(ke)的(de)(de)路(lu)(lu)径(jing)：一是完(wan)成支(zhi)持药(yao)(yao)品上(shang)市(shi)注册的(de)(de)药(yao)(yao)学、药(yao)(yao)理毒理学和药(yao)(yao)物(wu)临(lin)(lin)床(chuang)试验(yan)(yan)等研究，确定(ding)质(zhi)量标准，完(wan)成商业规(gui)模生产工艺验(yan)(yan)证后完(wan)整(zheng)的(de)(de)申(shen)(shen)报路(lu)(lu)径(jing)。二是经申(shen)(shen)请(qing)人(ren)评估无需或不能开展(zhan)药(yao)(yao)物(wu)临(lin)(lin)床(chuang)试验(yan)(yan)，符合豁免药(yao)(yao)物(wu)临(lin)(lin)床(chuang)试验(yan)(yan)条件的(de)(de)，申(shen)(shen)请(qing)人(ren)可(ke)以直接提(ti)出药(yao)(yao)品上(shang)市(shi)许可(ke)申(shen)(shen)请(qing)的(de)(de)路(lu)(lu)径(jing)。三(san)(san)是非处方药(yao)(yao)可(ke)以直接提(ti)出上(shang)市(shi)许可(ke)申(shen)(shen)请(qing)的(de)(de)路(lu)(lu)径(jing)。
十二、药(yao)品注(zhu)册(ce)核查程序进行了哪些优化？
这(zhei)次修(xiu)订《办法》，对药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册(ce)(ce)(ce)现(xian)场(chang)(chang)(chang)(chang)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)进(jin)行(xing)了优化(hua)(hua)：一(yi)是优化(hua)(hua)了药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册(ce)(ce)(ce)现(xian)场(chang)(chang)(chang)(chang)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)模式。不再(zai)实施“逢审必查(cha)(cha)(cha)(cha)(cha)(cha)”的(de)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)模式，对于(yu)(yu)(yu)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册(ce)(ce)(ce)研制(zhi)现(xian)场(chang)(chang)(chang)(chang)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)，根据药(yao)(yao)(yao)(yao)物(wu)创新(xin)程度、药(yao)(yao)(yao)(yao)物(wu)研究机(ji)构(gou)既往(wang)接(jie)受(shou)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)情况等(deng)，基于(yu)(yu)(yu)风(feng)险决(jue)(jue)定(ding)是否开展；对于(yu)(yu)(yu)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册(ce)(ce)(ce)生(sheng)产(chan)现(xian)场(chang)(chang)(chang)(chang)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)，根据申(shen)(shen)报注(zhu)册(ce)(ce)(ce)的(de)品(pin)(pin)(pin)种、工艺、设施、既往(wang)接(jie)受(shou)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)情况等(deng)因素，基于(yu)(yu)(yu)风(feng)险决(jue)(jue)定(ding)是否开展。二是做好药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册(ce)(ce)(ce)生(sheng)产(chan)现(xian)场(chang)(chang)(chang)(chang)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)和上(shang)市前药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)生(sheng)产(chan)质量管理(li)规(gui)范(fan)检(jian)查(cha)(cha)(cha)(cha)(cha)(cha)的(de)衔接(jie)，需要上(shang)市前药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)生(sheng)产(chan)质量管理(li)规(gui)范(fan)检(jian)查(cha)(cha)(cha)(cha)(cha)(cha)的(de)，由药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)中心协调相关省级药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)监督管理(li)部门(men)与(yu)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册(ce)(ce)(ce)生(sheng)产(chan)现(xian)场(chang)(chang)(chang)(chang)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)同步(bu)实施，加快(kuai)了药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)上(shang)市进(jin)程，与(yu)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)上(shang)市后(hou)监管进(jin)行(xing)有机(ji)衔接(jie)。三是明确了药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册(ce)(ce)(ce)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)的(de)定(ding)位，药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册(ce)(ce)(ce)核(he)(he)(he)(he)查(cha)(cha)(cha)(cha)(cha)(cha)不是全(quan)体系(xi)的(de)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)生(sheng)产(chan)质量管理(li)规(gui)范(fan)检(jian)查(cha)(cha)(cha)(cha)(cha)(cha)，其(qi)主(zhu)要目的(de)是核(he)(he)(he)(he)实申(shen)(shen)报资(zi)料的(de)真实性、一(yi)致性以(yi)及(ji)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)上(shang)市商业化(hua)(hua)生(sheng)产(chan)条件，检(jian)查(cha)(cha)(cha)(cha)(cha)(cha)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)研制(zhi)的(de)合(he)规(gui)性、数据可(ke)靠性等(deng)。
十(shi)三、药品(pin)注册检验(yan)程(cheng)序(xu)进行(xing)了哪些优(you)化？
这次修订《办(ban)法》，对药(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册检(jian)验程(cheng)序进行了(le)优化：申(shen)(shen)请(qing)人可以(yi)在完成支持药(yao)品(pin)(pin)(pin)(pin)(pin)上(shang)市的药(yao)学(xue)相关(guan)研究(jiu)，确(que)定质量标(biao)准(zhun)(zhun)，并完成商业规模生(sheng)产(chan)工(gong)艺验证后，可以(yi)在药(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册申(shen)(shen)请(qing)受(shou)理(li)前(qian)提出(chu)药(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册检(jian)验，在药(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册申(shen)(shen)请(qing)受(shou)理(li)前(qian)未提出(chu)药(yao)品(pin)(pin)(pin)(pin)(pin)注(zhu)册检(jian)验的，由(you)药(yao)品(pin)(pin)(pin)(pin)(pin)审(shen)评中(zhong)心(xin)在受(shou)理(li)后四十日(ri)内启动。药(yao)品(pin)(pin)(pin)(pin)(pin)检(jian)验机构原(yuan)则(ze)上(shang)应当在审(shen)评时限届满四十日(ri)前(qian)，将(jiang)标(biao)准(zhun)(zhun)复核(he)意见和检(jian)验报(bao)告(gao)反馈至药(yao)品(pin)(pin)(pin)(pin)(pin)审(shen)评中(zhong)心(xin)。在要求不减少、标(biao)准(zhun)(zhun)不降低的前(qian)提下，根据产(chan)品(pin)(pin)(pin)(pin)(pin)研发的实际进展(zhan)，科学(xue)合(he)理(li)地设置(zhi)、优化注(zhu)册流(liu)程(cheng)，缩短上(shang)市注(zhu)册审(shen)评审(shen)批(pi)总时限。
十四、药品变(bian)更管(guan)理(li)做了哪(na)些优化？
这次修订《办(ban)法(fa)(fa)》，根(gen)据药(yao)物(wu)研(yan)制(zhi)规律(lv)，对现有(you)的(de)(de)药(yao)品(pin)(pin)上(shang)市(shi)后变(bian)(bian)(bian)更(geng)(geng)程(cheng)(cheng)序和(he)要(yao)求进行(xing)优化，并且新明(ming)(ming)(ming)确(que)(que)(que)药(yao)物(wu)临(lin)床试(shi)(shi)验期(qi)(qi)(qi)间(jian)变(bian)(bian)(bian)更(geng)(geng)和(he)药(yao)品(pin)(pin)上(shang)市(shi)许(xu)可(ke)审(shen)评(ping)期(qi)(qi)(qi)间(jian)变(bian)(bian)(bian)更(geng)(geng)的(de)(de)路(lu)径：一是明(ming)(ming)(ming)确(que)(que)(que)药(yao)物(wu)临(lin)床试(shi)(shi)验期(qi)(qi)(qi)间(jian)变(bian)(bian)(bian)更(geng)(geng)的(de)(de)程(cheng)(cheng)序和(he)要(yao)求。对于(yu)临(lin)床试(shi)(shi)验期(qi)(qi)(qi)间(jian)变(bian)(bian)(bian)更(geng)(geng)的(de)(de)管理，尊(zun)重(zhong)药(yao)物(wu)研(yan)制(zhi)规律(lv)，增(zeng)加(jia)了(le)对药(yao)物(wu)临(lin)床试(shi)(shi)验期(qi)(qi)(qi)间(jian)变(bian)(bian)(bian)更(geng)(geng)要(yao)求和(he)程(cheng)(cheng)序，根(gen)据对受试(shi)(shi)者(zhe)安(an)全的(de)(de)影(ying)响(xiang)程(cheng)(cheng)度采取申(shen)报(bao)变(bian)(bian)(bian)更(geng)(geng)或报(bao)告(gao)的(de)(de)方式进行(xing)管理。二是明(ming)(ming)(ming)确(que)(que)(que)了(le)上(shang)市(shi)审(shen)评(ping)期(qi)(qi)(qi)间(jian)的(de)(de)变(bian)(bian)(bian)更(geng)(geng)管理原(yuan)则。上(shang)市(shi)许(xu)可(ke)审(shen)评(ping)期(qi)(qi)(qi)间(jian)，发生(sheng)(sheng)可(ke)能影(ying)响(xiang)药(yao)品(pin)(pin)安(an)全性(xing)、有(you)效(xiao)性(xing)和(he)质量可(ke)控性(xing)的(de)(de)重(zhong)大变(bian)(bian)(bian)更(geng)(geng)的(de)(de)，申(shen)请(qing)人应当撤(che)回原(yuan)注册申(shen)请(qing)，补充研(yan)究后重(zhong)新申(shen)报(bao)；不涉(she)及技术内容(rong)的(de)(de)变(bian)(bian)(bian)更(geng)(geng)，应当及时(shi)告(gao)知药(yao)品(pin)(pin)审(shen)评(ping)中心并提交相关证明(ming)(ming)(ming)性(xing)材(cai)料。三是对于(yu)上(shang)市(shi)后变(bian)(bian)(bian)更(geng)(geng)的(de)(de)管理，在原(yuan)《办(ban)法(fa)(fa)》规定需(xu)要(yao)报(bao)补充申(shen)请(qing)和(he)备案的(de)(de)基(ji)础上(shang)，增(zeng)加(jia)了(le)年度报(bao)告(gao)的(de)(de)途径。四是生(sheng)(sheng)产场地变(bian)(bian)(bian)更(geng)(geng)需(xu)要(yao)按(an)照《药(yao)品(pin)(pin)生(sheng)(sheng)产监督管理办(ban)法(fa)(fa)》第十六(liu)条(tiao)的(de)(de)规定执行(xing)。
十五、补充资料程(cheng)序进行了(le)哪些优化(hua)？
这(zhei)次(ci)修(xiu)订(ding)《办法》，对(dui)(dui)补(bu)(bu)充(chong)(chong)(chong)资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)的(de)程序和要(yao)(yao)(yao)求(qiu)进行了细(xi)化和优化：一(yi)是(shi)(shi)需要(yao)(yao)(yao)申(shen)(shen)请(qing)(qing)人(ren)在(zai)(zai)(zai)原(yuan)申(shen)(shen)报资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)基础上(shang)补(bu)(bu)充(chong)(chong)(chong)新的(de)技(ji)术资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)，即有新的(de)研(yan)究数据(ju)需要(yao)(yao)(yao)再次(ci)进行审(shen)评的(de)，药品审(shen)评中心发(fa)出补(bu)(bu)充(chong)(chong)(chong)资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)要(yao)(yao)(yao)求(qiu)时(shi)(shi)列明(ming)(ming)全部问题(ti)，原(yuan)则上(shang)只能(neng)提(ti)出一(yi)次(ci)补(bu)(bu)充(chong)(chong)(chong)资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)要(yao)(yao)(yao)求(qiu)，申(shen)(shen)请(qing)(qing)人(ren)应当按要(yao)(yao)(yao)求(qiu)一(yi)次(ci)性提(ti)交全部补(bu)(bu)充(chong)(chong)(chong)资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)，此种补(bu)(bu)充(chong)(chong)(chong)资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)的(de)时(shi)(shi)限是(shi)(shi)八十日。二是(shi)(shi)新增了对(dui)(dui)申(shen)(shen)报资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)解释(shi)说明(ming)(ming)的(de)途径，需要(yao)(yao)(yao)申(shen)(shen)请(qing)(qing)人(ren)仅对(dui)(dui)原(yuan)申(shen)(shen)报资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)进行解释(shi)说明(ming)(ming)，不(bu)(bu)(bu)需要(yao)(yao)(yao)补(bu)(bu)充(chong)(chong)(chong)新的(de)研(yan)究数据(ju)。此种补(bu)(bu)充(chong)(chong)(chong)资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)的(de)时(shi)(shi)限是(shi)(shi)五(wu)日，审(shen)评计时(shi)(shi)不(bu)(bu)(bu)停摆。三是(shi)(shi)药物(wu)临(lin)床试验(yan)申(shen)(shen)请(qing)(qing)、药物(wu)临(lin)床试验(yan)期间的(de)补(bu)(bu)充(chong)(chong)(chong)申(shen)(shen)请(qing)(qing)实(shi)施默示许可，由于时(shi)(shi)限仅有六十日，因此在(zai)(zai)(zai)审(shen)评期间，不(bu)(bu)(bu)得补(bu)(bu)充(chong)(chong)(chong)新的(de)技(ji)术资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)，仅允许对(dui)(dui)原(yuan)申(shen)(shen)报资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)进行解释(shi)说明(ming)(ming)。四(si)是(shi)(shi)存在(zai)(zai)(zai)实(shi)质(zhi)性缺陷无法补(bu)(bu)正的(de)，不(bu)(bu)(bu)再要(yao)(yao)(yao)求(qiu)申(shen)(shen)请(qing)(qing)人(ren)补(bu)(bu)充(chong)(chong)(chong)资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)，基于已有申(shen)(shen)报资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)做出不(bu)(bu)(bu)予(yu)(yu)批(pi)准的(de)决定。五(wu)是(shi)(shi)申(shen)(shen)请(qing)(qing)人(ren)未能(neng)在(zai)(zai)(zai)上(shang)述规定时(shi)(shi)限内补(bu)(bu)充(chong)(chong)(chong)资(zi)(zi)(zi)(zi)(zi)(zi)料(liao)(liao)的(de)，该药品注(zhu)册申(shen)(shen)请(qing)(qing)不(bu)(bu)(bu)予(yu)(yu)批(pi)准。
十六、如何实现药(yao)品注册时限(xian)可预(yu)期？
这次修(xiu)订《办法》，对业界普(pu)遍关(guan)(guan)心的(de)(de)药(yao)品(pin)注(zhu)册时(shi)(shi)限(xian)(xian)进行(xing)了优化：一(yi)是明(ming)确药(yao)品(pin)注(zhu)册管理(li)(li)各环(huan)节各部(bu)门(men)的(de)(de)职责，做好药(yao)品(pin)注(zhu)册受理(li)(li)、审(shen)评(ping)、核查和检验(yan)等各环(huan)节的(de)(de)衔接，提(ti)高药(yao)品(pin)注(zhu)册效率和注(zhu)册时(shi)(shi)限(xian)(xian)的(de)(de)预期性。二是明(ming)晰(xi)各项具(ju)体(ti)工作的(de)(de)负责部(bu)门(men)，将(jiang)(jiang)各项具(ju)体(ti)工作明(ming)确到具(ju)体(ti)负责的(de)(de)有关(guan)(guan)单位。三是将(jiang)(jiang)原(yuan)来的(de)(de)审(shen)评(ping)、核查和检验(yan)由“串联”改成“并联”，在审(shen)评(ping)时(shi)(shi)限(xian)(xian)的(de)(de)二百日内，明(ming)确审(shen)评(ping)过程中提(ti)出核查检验(yan)启(qi)动时(shi)(shi)间(jian)点为(wei)受理(li)(li)后四十(shi)日内，完成时(shi)(shi)间(jian)点为(wei)审(shen)评(ping)时(shi)(shi)限(xian)(xian)结束前四十(shi)日，保证总时(shi)(shi)限(xian)(xian)可控。
十七(qi)、如何做到药品注册(ce)工作公开透(tou)明？
提(ti)高审(shen)(shen)评(ping)(ping)审(shen)(shen)批透明(ming)度是(shi)(shi)近年来药(yao)(yao)(yao)(yao)品(pin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批制(zhi)度改革的重(zhong)要(yao)任务。这次修订《办(ban)法》在总则明(ming)确(que)了(le)药(yao)(yao)(yao)(yao)品(pin)注册(ce)管理遵循(xun)公(gong)(gong)开、公(gong)(gong)平、公(gong)(gong)正的原则，并在《办(ban)法》正文(wen)加强(qiang)药(yao)(yao)(yao)(yao)品(pin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批过程(cheng)公(gong)(gong)开透明(ming)、加强(qiang)社(she)(she)(she)(she)会(hui)(hui)监(jian)督(du)、保(bao)护持(chi)有人合(he)法权(quan)益和(he)保(bao)障审(shen)(shen)评(ping)(ping)审(shen)(shen)批公(gong)(gong)平公(gong)(gong)正作出清(qing)晰的规(gui)定：一是(shi)(shi)国家局依(yi)法向(xiang)(xiang)社(she)(she)(she)(she)会(hui)(hui)公(gong)(gong)布药(yao)(yao)(yao)(yao)品(pin)注册(ce)审(shen)(shen)批事(shi)项清(qing)单(dan)及(ji)法律依(yi)据(ju)、审(shen)(shen)批要(yao)求和(he)办(ban)理时(shi)(shi)(shi)限，向(xiang)(xiang)申请人公(gong)(gong)开药(yao)(yao)(yao)(yao)品(pin)注册(ce)进度，公(gong)(gong)示药(yao)(yao)(yao)(yao)物(wu)临床试验结(jie)果信息，向(xiang)(xiang)社(she)(she)(she)(she)会(hui)(hui)公(gong)(gong)开批准上市(shi)药(yao)(yao)(yao)(yao)品(pin)的审(shen)(shen)评(ping)(ping)结(jie)论(lun)和(he)依(yi)据(ju)以及(ji)监(jian)督(du)检查发现的违法违规(gui)行为(wei)，接(jie)受社(she)(she)(she)(she)会(hui)(hui)监(jian)督(du)，实现社(she)(she)(she)(she)会(hui)(hui)共治(zhi)。二(er)是(shi)(shi)批准上市(shi)药(yao)(yao)(yao)(yao)品(pin)的说明(ming)书应当(dang)向(xiang)(xiang)社(she)(she)(she)(she)会(hui)(hui)公(gong)(gong)开并及(ji)时(shi)(shi)(shi)更新(xin)。其中，疫苗(miao)还应当(dang)公(gong)(gong)开标签内容(rong)并及(ji)时(shi)(shi)(shi)更新(xin)。三是(shi)(shi)建立(li)收(shou)载新(xin)批准上市(shi)以及(ji)通过仿制(zhi)药(yao)(yao)(yao)(yao)质量和(he)疗(liao)效一致性(xing)评(ping)(ping)价的化学药(yao)(yao)(yao)(yao)品(pin)目录(lu)集，载明(ming)药(yao)(yao)(yao)(yao)品(pin)名称、活性(xing)成分、剂(ji)型、规(gui)格(ge)、是(shi)(shi)否(fou)为(wei)参(can)比制(zhi)剂(ji)、持(chi)有人等(deng)相关(guan)信息，及(ji)时(shi)(shi)(shi)更新(xin)并向(xiang)(xiang)社(she)(she)(she)(she)会(hui)(hui)公(gong)(gong)开。
十八、对药品(pin)注(zhu)册(ce)申请的审评审批(pi)结论(lun)有争议时有哪些救济途径？
这次修订(ding)《办法》，根据(ju)前(qian)期改革经验，对(dui)药品注册(ce)申请(qing)(qing)审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批结论有(you)争议(yi)的(de)救济途径进行了优化(hua)：一是为(wei)简(jian)化(hua)程(cheng)序(xu)，提高实(shi)效，新修订(ding)《办法》不再单设审(shen)(shen)(shen)批结束(shu)后的(de)复审(shen)(shen)(shen)程(cheng)序(xu)，而是将(jiang)(jiang)复审(shen)(shen)(shen)工(gong)作的(de)实(shi)质内容前(qian)置到审(shen)(shen)(shen)评(ping)(ping)结束(shu)前(qian)，对(dui)审(shen)(shen)(shen)评(ping)(ping)结论有(you)异议(yi)的(de)，申请(qing)(qing)人(ren)可以(yi)(yi)在(zai)(zai)审(shen)(shen)(shen)评(ping)(ping)阶(jie)段提出，将(jiang)(jiang)异议(yi)问题尽(jin)早在(zai)(zai)前(qian)端(duan)解(jie)决。二是审(shen)(shen)(shen)批结束(shu)后，申请(qing)(qing)人(ren)仍有(you)异议(yi)的(de)，可以(yi)(yi)采取行政(zheng)复议(yi)和行政(zheng)诉讼(song)等手段维护权益。
十九(jiu)、《办法》有哪些相关文(wen)件和工作？
《办法》发布(bu)后有多项需要配(pei)套开(kai)展(zhan)的(de)(de)(de)工作和(he)(he)发布(bu)的(de)(de)(de)文(wen)件，同时还要根据工作需要补充增(zeng)加，与之配(pei)套的(de)(de)(de)规范性(xing)文(wen)件和(he)(he)技(ji)(ji)术指(zhi)导(dao)(dao)原(yuan)则(ze)等正(zheng)在加快(kuai)制修订(ding)。目前正(zheng)在重点推(tui)进中药、化学药和(he)(he)生物(wu)制品(pin)的(de)(de)(de)注(zhu)册分(fen)类及(ji)申(shen)报(bao)资(zi)(zi)料要求、变更分(fen)类及(ji)申(shen)报(bao)资(zi)(zi)料要求、再注(zhu)册申(shen)报(bao)资(zi)(zi)料要求、持有人变更上(shang)市许可等配(pei)套文(wen)件，将(jiang)按照成熟(shu)一个(ge)发布(bu)一个(ge)的(de)(de)(de)原(yuan)则(ze)，陆续(xu)(xu)发布(bu)实(shi)施。后续(xu)(xu)，将(jiang)进一步丰富技(ji)(ji)术指(zhi)导(dao)(dao)原(yuan)则(ze)体(ti)系(xi)，提升技(ji)(ji)术指(zhi)导(dao)(dao)原(yuan)则(ze)体(ti)系(xi)的(de)(de)(de)全(quan)面性(xing)和(he)(he)系(xi)统性(xing)，既为审评审批(pi)、核查检验提供技(ji)(ji)术参考，又为支持行业发展(zhan)、鼓励创新提供引导(dao)(dao)。
