2020年度药品审评报告

时间:2020-06-22

2020年(nian)是极(ji)不平(ping)凡的(de)(de)一(yi)年(nian),面(mian)对(dui)突如其来的(de)(de)新(xin)(xin)冠肺炎(yan)疫情(qing),国(guo)(guo)家(jia)(jia)药(yao)(yao)(yao)品(pin)监(jian)督(du)管(guan)理(li)局(ju)(ju)药(yao)(yao)(yao)品(pin)审(shen)(shen)(shen)(shen)评(ping)中心(以(yi)下简称(cheng)药(yao)(yao)(yao)审(shen)(shen)(shen)(shen)中心)在国(guo)(guo)家(jia)(jia)药(yao)(yao)(yao)品(pin)监(jian)督(du)管(guan)理(li)局(ju)(ju)(以(yi)下简称(cheng)国(guo)(guo)家(jia)(jia)药(yao)(yao)(yao)监(jian)局(ju)(ju))的(de)(de)坚(jian)强领导下,认真学习(xi)贯彻习(xi)近平(ping)总书记重(zhong)要讲话和重(zhong)要指示(shi)批示(shi)精神,闻令而动(dong)、尽锐出战,坚(jian)持人民至(zhi)上(shang)(shang)、生命至(zhi)上(shang)(shang),超(chao)常规(gui)建立“早期(qi)介入、持续跟踪、主(zhu)动(dong)服务(wu)(wu)、研(yan)审(shen)(shen)(shen)(shen)联(lian)动(dong)”全天候应急(ji)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批工(gong)(gong)作(zuo)机制(zhi),加速推(tui)动(dong)新(xin)(xin)冠病毒疫苗和新(xin)(xin)冠肺炎(yan)治(zhi)疗药(yao)(yao)(yao)物研(yan)发上(shang)(shang)市(shi),充分发挥技术审(shen)(shen)(shen)(shen)评(ping)对(dui)疫情(qing)防控的(de)(de)科技支撑作(zuo)用;主(zhu)动(dong)服务(wu)(wu)于药(yao)(yao)(yao)监(jian)系统工(gong)(gong)作(zuo)大局(ju)(ju),紧紧围绕落实党中央国(guo)(guo)务(wu)(wu)院审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批制(zhi)度改革、贯彻《药(yao)(yao)(yao)品(pin)管(guan)理(li)法(fa)》《疫苗管(guan)理(li)法(fa)》《药(yao)(yao)(yao)品(pin)注册管(guan)理(li)办法(fa)》、推(tui)动(dong)审(shen)(shen)(shen)(shen)评(ping)体(ti)系和审(shen)(shen)(shen)(shen)评(ping)能(neng)力(li)现代化(hua),统筹推(tui)进疫情(qing)防控和依法(fa)依规(gui)科学审(shen)(shen)(shen)(shen)评(ping)工(gong)(gong)作(zuo),不断提(ti)高审(shen)(shen)(shen)(shen)评(ping)质(zhi)量和效(xiao)率,不断加快新(xin)(xin)药(yao)(yao)(yao)研(yan)发上(shang)(shang)市(shi)步伐,为疫情(qing)防控和满(man)足(zu)临床急(ji)需提(ti)供有效(xiao)药(yao)(yao)(yao)物保(bao)障、为医药(yao)(yao)(yao)产业高质(zhi)量发展(zhan)提(ti)供有力(li)促进作(zuo)用,保(bao)障了人民群众用药(yao)(yao)(yao)安全有效(xiao)可及,药(yao)(yao)(yao)品(pin)审(shen)(shen)(shen)(shen)评(ping)事业得到(dao)新(xin)(xin)发展(zhan)、迈(mai)上(shang)(shang)新(xin)(xin)台阶(jie)、开创新(xin)(xin)局(ju)(ju)面(mian)。 

一(yi)、药品注(zhu)册申请(qing)审(shen)评审(shen)批(pi)情况

(一)总(zong)体完成情况

1.全年审(shen)评(ping)审(shen)批完成情况(kuang)

2020年(nian),根据(ju)《药(yao)(yao)品(pin)注(zhu)册(ce)管理(li)办(ban)法(fa)》(国(guo)家(jia)市(shi)场监督管理(li)总局令(ling)第27号)、《国(guo)家(jia)药(yao)(yao)监局关于(yu)实施<药(yao)(yao)品(pin)注(zhu)册(ce)管理(li)办(ban)法(fa)>有关事宜的(de)公告(gao)》(2020年(nian)第46号,以(yi)下(xia)简称46号公告(gao))及《药(yao)(yao)品(pin)注(zhu)册(ce)管理(li)办(ban)法(fa)》相(xiang)关配(pei)套(tao)文件(jian),药(yao)(yao)审(shen)(shen)(shen)中(zhong)心(xin)(xin)完(wan)成中(zhong)药(yao)(yao)(包括民族(zu)药(yao)(yao),下(xia)同)、化学药(yao)(yao)、生物制品(pin)各类注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)(pi)共11582件(jian)(含器械(xie)组合产品(pin)4件(jian),以(yi)受理(li)号计,下(xia)同),较2019年(nian)增长32.67%(如无说明(ming),以(yi)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)件(jian)数计,下(xia)同)。其中(zhong),完(wan)成需技(ji)术审(shen)(shen)(shen)评(ping)(ping)的(de)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)8606件(jian)(含5674件(jian)需药(yao)(yao)审(shen)(shen)(shen)中(zhong)心(xin)(xin)技(ji)术审(shen)(shen)(shen)评(ping)(ping)和行政(zheng)审(shen)(shen)(shen)批(pi)(pi)(pi)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)),较2019年(nian)增长26.24%;完(wan)成直(zhi)接(jie)行政(zheng)审(shen)(shen)(shen)批(pi)(pi)(pi)(无需技(ji)术审(shen)(shen)(shen)评(ping)(ping),下(xia)同)的(de)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)2972件(jian)。2020年(nian)底正在审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)(pi)和等待审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)(pi)的(de)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)已由2015年(nian)9月高峰时(shi)的(de)近22000件(jian)降至(zhi)4882件(jian)(不含完(wan)成技(ji)术审(shen)(shen)(shen)评(ping)(ping)因申(shen)(shen)报资料(liao)缺陷等待申(shen)(shen)请(qing)(qing)(qing)(qing)人(ren)回复补(bu)充(chong)资料(liao)的(de)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing))。

完(wan)成8606件(jian)需技(ji)术审(shen)评(ping)的药品(pin)注(zhu)册(ce)申(shen)请(qing)中,化(hua)(hua)学药注(zhu)册(ce)申(shen)请(qing)为6778件(jian),较2019年(nian)增(zeng)(zeng)长(zhang)25.22%;中药注(zhu)册(ce)申(shen)请(qing)418件(jian),较2019年(nian)增(zeng)(zeng)长(zhang)39.33%;生物制品(pin)注(zhu)册(ce)申(shen)请(qing)1410件(jian),较2019年(nian)增(zeng)(zeng)长(zhang)27.72%;化(hua)(hua)学药注(zhu)册(ce)申(shen)请(qing)约占(zhan)全(quan)部技(ji)术审(shen)评(ping)完(wan)成量的78.76%。2016-2020年(nian)中药、生物制品(pin)、化(hua)(hua)学药注(zhu)册(ce)申(shen)请(qing)审(shen)评(ping)审(shen)批完(wan)成情况详见图1。

 

 

  药(yao)(yao)审(shen)中(zhong)心完(wan)(wan)(wan)成(cheng)(cheng)需技术(shu)审(shen)评(ping)(ping)的8606件(jian)(jian)注(zhu)册(ce)申(shen)请(qing)(qing)(qing)中(zhong),完(wan)(wan)(wan)成(cheng)(cheng)新药(yao)(yao)临床试验(IND)申(shen)请(qing)(qing)(qing)审(shen)评(ping)(ping)1561件(jian)(jian),较2019年(nian)(nian)增长55.94%;完(wan)(wan)(wan)成(cheng)(cheng)新药(yao)(yao)上市申(shen)请(qing)(qing)(qing)(NDA)审(shen)评(ping)(ping)289件(jian)(jian),完(wan)(wan)(wan)成(cheng)(cheng)仿(fang)制药(yao)(yao)上市申(shen)请(qing)(qing)(qing)(ANDA)审(shen)评(ping)(ping)1700件(jian)(jian);完(wan)(wan)(wan)成(cheng)(cheng)仿(fang)制药(yao)(yao)质(zhi)量和(he)疗(liao)效一致(zhi)性(xing)评(ping)(ping)价(以(yi)下简(jian)称(cheng)一致(zhi)性(xing)评(ping)(ping)价)申(shen)请(qing)(qing)(qing)(以(yi)补充申(shen)请(qing)(qing)(qing)途(tu)径申(shen)报)1136件(jian)(jian),较2019年(nian)(nian)增长103.22%;完(wan)(wan)(wan)成(cheng)(cheng)补充申(shen)请(qing)(qing)(qing)技术(shu)审(shen)评(ping)(ping)3250件(jian)(jian),较2019年(nian)(nian)增长24.19%。2016-2020年(nian)(nian)各类注(zhu)册(ce)申(shen)请(qing)(qing)(qing)审(shen)评(ping)(ping)完(wan)(wan)(wan)成(cheng)(cheng)情况详见(jian)图2。

 

3.审评通过情况

2020年(nian)(nian),药审(shen)中心(xin)审(shen)评(ping)通(tong)(tong)过批(pi)准IND申请(qing)1435件(jian),较(jiao)2019年(nian)(nian)增长(zhang)54.97%;审(shen)评(ping)通(tong)(tong)过NDA 208件(jian),较(jiao)2019年(nian)(nian)增长(zhang)26.83%;审(shen)评(ping)通(tong)(tong)过ANDA 918件(jian);审(shen)评(ping)通(tong)(tong)过批(pi)准一致性(xing)评(ping)价申请(qing)577件(jian),较(jiao)2019年(nian)(nian)增长(zhang)121.92%。

药审(shen)中心审(shen)评(ping)通(tong)过(guo)创新药NDA 20个品(pin)(pin)种,审(shen)评(ping)通(tong)过(guo)境外生产原研药品(pin)(pin)NDA 72个品(pin)(pin)种(含新增适应症品(pin)(pin)种),具体品(pin)(pin)种详见附件1、2。

4.审结(jie)注册申请任务按时限完成情(qing)况

2020年(nian)(nian),药审(shen)中(zhong)心持续优化审(shen)评流程(cheng),严格审(shen)评时限管理(li),加强项目督导,加快(kuai)审(shen)评速度,整体审(shen)评任(ren)(ren)务(wu)和重点序列(lie)审(shen)评任(ren)(ren)务(wu)按(an)(an)时限完(wan)(wan)成(cheng)率(lv)均取得显著提升(sheng)。全年(nian)(nian)审(shen)结注(zhu)册(ce)申(shen)请(qing)任(ren)(ren)务(wu)整体按(an)(an)时限完(wan)(wan)成(cheng)率(lv)为(wei)(wei)94.48%,其中(zhong)临(lin)床(chuang)急需境外(wai)已上市新药注(zhu)册(ce)申(shen)请(qing)审(shen)结任(ren)(ren)务(wu)整体按(an)(an)时限完(wan)(wan)成(cheng)率(lv)为(wei)(wei)100%,按(an)(an)默(mo)示许可受理(li)注(zhu)册(ce)申(shen)请(qing)的审(shen)结任(ren)(ren)务(wu)整体按(an)(an)时限完(wan)(wan)成(cheng)率(lv)为(wei)(wei)99.87%,直接行(xing)政审(shen)批的注(zhu)册(ce)申(shen)请(qing)100%在(zai)法定的20个(ge)工作日内完(wan)(wan)成(cheng),且(qie)审(shen)批平均用时11.8个(ge)工作日。各类注(zhu)册(ce)申(shen)请(qing)任(ren)(ren)务(wu)按(an)(an)时限完(wan)(wan)成(cheng)情况详见表(biao)1。

 

  2020年(nian)的NDA年(nian)度整体按(an)时(shi)(shi)限完(wan)(wan)成(cheng)(cheng)(cheng)率(lv)已经有了很大的提(ti)升,例(li)如:NDA按(an)时(shi)(shi)限完(wan)(wan)成(cheng)(cheng)(cheng)率(lv)在(zai)2020年(nian)12月(yue)突(tu)(tu)破80%,提(ti)升至87.5%;ANDA按(an)时(shi)(shi)限完(wan)(wan)成(cheng)(cheng)(cheng)率(lv)在(zai)2020年(nian)12月(yue)突(tu)(tu)破90%,达到(dao)93.85%;纳入优先审(shen)评程(cheng)序的注册申(shen)请按(an)时(shi)(shi)限完(wan)(wan)成(cheng)(cheng)(cheng)率(lv)在(zai)2020年(nian)10-12月(yue)的月(yue)度按(an)时(shi)(shi)限完(wan)(wan)成(cheng)(cheng)(cheng)率(lv)连续达到(dao)90%以(yi)上,取得(de)历史性(xing)突(tu)(tu)破。

(二)中药注册(ce)申(shen)请(qing)审评(ping)完成(cheng)情况

1.总体情(qing)况

2020年,药(yao)(yao)审(shen)中(zhong)心完(wan)成(cheng)(cheng)(cheng)审(shen)评(ping)的中(zhong)药(yao)(yao)注(zhu)册申请(qing)418件(jian)。其中(zhong),完(wan)成(cheng)(cheng)(cheng)IND申请(qing)37件(jian),完(wan)成(cheng)(cheng)(cheng)NDA 8件(jian),完(wan)成(cheng)(cheng)(cheng)ANDA 3件(jian)。2020年中(zhong)药(yao)(yao)各类注(zhu)册申请(qing)的审(shen)评(ping)完(wan)成(cheng)(cheng)(cheng)情况详(xiang)见图3。

 

2.审评通过情况

药(yao)审中心审评(ping)通(tong)过批准(zhun)中药(yao)IND申请28件(jian),审评(ping)通(tong)过中药(yao)NDA 4件(jian)(连花清咳(ke)片(pian)、筋(jin)骨止痛凝胶(jiao)、桑枝总生物(wu)碱(jian)片(pian)及桑枝总生物(wu)碱(jian))。2020年中药(yao)各类注(zhu)册申请审评(ping)完成的(de)具体情况(kuang)详见表2,2016-2020年审评(ping)通(tong)过批准(zhun)中药(yao)IND申请和审评(ping)通(tong)过中药(yao)NDA情况(kuang)详见图4。

 

 

  药审中(zhong)心审评通过(guo)批准的(de)中(zhong)药IND申(shen)请(qing)(qing)28件(jian),涉及10个(ge)适(shi)应(ying)症(zheng)(zheng)领(ling)域。其中(zhong),呼吸7件(jian)、骨(gu)科(ke)4件(jian)、消化4件(jian),共占53.57%,2020年(nian)审评通过(guo)批准的(de)中(zhong)药IND申(shen)请(qing)(qing)适(shi)应(ying)症(zheng)(zheng)分布详见图5。

 

(三)化学药(yao)注册申请审评完成情况

1.总体情况

2020年(nian)(nian)(nian),药(yao)审(shen)中心完(wan)(wan)成(cheng)审(shen)评的化(hua)学(xue)药(yao)注(zhu)册(ce)申(shen)请(qing)6778件。其中,完(wan)(wan)成(cheng)化(hua)学(xue)药(yao)临(lin)床申(shen)请(qing)(IND申(shen)请(qing)和验证性临(lin)床)共1086件,较2019年(nian)(nian)(nian)增长(zhang)45.58%;完(wan)(wan)成(cheng)化(hua)学(xue)药(yao)NDA 163件;完(wan)(wan)成(cheng)化(hua)学(xue)药(yao)ANDA 1697件;完(wan)(wan)成(cheng)一致性评价申(shen)请(qing)1136件,较2019年(nian)(nian)(nian)增长(zhang)103.22%;完(wan)(wan)成(cheng)化(hua)学(xue)药(yao)补充申(shen)请(qing)2248件,较2019年(nian)(nian)(nian)增长(zhang)23.72%。2020年(nian)(nian)(nian)化(hua)学(xue)药(yao)各类注(zhu)册(ce)申(shen)请(qing)的审(shen)评完(wan)(wan)成(cheng)情况详见图6。

 

2.审评通过情况

药(yao)(yao)审(shen)(shen)中心(xin)完成审(shen)(shen)评的(de)化学(xue)药(yao)(yao)注册(ce)申(shen)请中,审(shen)(shen)评通(tong)(tong)过(guo)批准(zhun)IND申(shen)请907件,较(jiao)2019年增(zeng)长51.42%;审(shen)(shen)评通(tong)(tong)过(guo)NDA 115件,较(jiao)2019年增(zeng)长30.68%;审(shen)(shen)评通(tong)(tong)过(guo)ANDA 918件,较(jiao)2019年增(zeng)长15.33%。2020年化学(xue)药(yao)(yao)各(ge)类注册(ce)申(shen)请审(shen)(shen)评完成的(de)具体情况详见表3。

 

药(yao)审(shen)(shen)(shen)中心(xin)完成(cheng)审(shen)(shen)(shen)评的化学药(yao)IND申请(qing)(qing)960件,审(shen)(shen)(shen)评通过(guo)批准(zhun)IND申请(qing)(qing)907件。其中,1类创(chuang)新(xin)化学药(yao)IND申请(qing)(qing)694件(298个品种(zhong)(zhong)),较2019年增长(zhang)40.77%,品种(zhong)(zhong)数较2019年增长(zhang)57.67%。2016-2020年审(shen)(shen)(shen)评通过(guo)批准(zhun)化学药(yao)IND申请(qing)(qing)、1类创(chuang)新(xin)化学药(yao)IND申请(qing)(qing)情况(kuang)详见图(tu)7。

 

药(yao)审中心(xin)审评通(tong)过批(pi)准(zhun)(zhun)IND申请的(de)694件1类创(chuang)新(xin)(xin)化(hua)学(xue)药(yao)中,抗(kang)肿(zhong)瘤药(yao)物(wu)、抗(kang)感染药(yao)物(wu)、循环(huan)系统疾病药(yao)物(wu)、内分泌系统药(yao)物(wu)、消化(hua)系统疾病药(yao)物(wu)和风(feng)湿性疾病及免疫药(yao)物(wu)较多,占全部创(chuang)新(xin)(xin)药(yao)临床试验批(pi)准(zhun)(zhun)数量的(de)80.69%。2020年审评通(tong)过批(pi)准(zhun)(zhun)的(de)1类创(chuang)新(xin)(xin)化(hua)学(xue)药(yao)IND申请适应症分布详见图8。

 

药(yao)审(shen)(shen)(shen)中(zhong)心(xin)完成审(shen)(shen)(shen)评(ping)的化学(xue)药(yao)NDA共(gong)163件。其中(zhong),审(shen)(shen)(shen)评(ping)通(tong)过(guo)化药(yao)NDA 115件,审(shen)(shen)(shen)评(ping)通(tong)过(guo)1类创新化学(xue)药(yao)NDA 14个品种。2016-2020年审(shen)(shen)(shen)评(ping)通(tong)过(guo)化学(xue)药(yao)NDA情况详见(jian)图9。

 

  药审(shen)(shen)中(zhong)心完成审(shen)(shen)评(ping)(ping)(ping)的(de)一(yi)致性评(ping)(ping)(ping)价(jia)(jia)申(shen)请共(gong)1136件(jian)(jian),审(shen)(shen)评(ping)(ping)(ping)通过577件(jian)(jian)。其(qi)中(zhong),审(shen)(shen)评(ping)(ping)(ping)通过批(pi)准口服(fu)固体(ti)制剂一(yi)致性评(ping)(ping)(ping)价(jia)(jia)456件(jian)(jian),审(shen)(shen)评(ping)(ping)(ping)通过批(pi)准注射剂一(yi)致性评(ping)(ping)(ping)价(jia)(jia)申(shen)请121件(jian)(jian),具体(ti)品(pin)种详见(jian)附件(jian)(jian)3。2018-2020年审(shen)(shen)评(ping)(ping)(ping)通过批(pi)准的(de)一(yi)致性评(ping)(ping)(ping)价(jia)(jia)申(shen)请情况详见(jian)图10。

 

(四)生(sheng)物制(zhi)品注册申请(qing)审评完成情况

1.总体情况(kuang)

2020年,药审(shen)中心完(wan)成(cheng)(cheng)审(shen)评的(de)生物(wu)制(zhi)品(pin)注(zhu)册(ce)申请(qing)(qing)共1410件(jian)(jian)。其中,完(wan)成(cheng)(cheng)预防(fang)用(yong)(yong)生物(wu)制(zhi)品(pin)IND申请(qing)(qing)(预防(fang)用(yong)(yong)IND申请(qing)(qing))27件(jian)(jian),完(wan)成(cheng)(cheng)治(zhi)疗用(yong)(yong)生物(wu)制(zhi)品(pin)IND申请(qing)(qing)(治(zhi)疗用(yong)(yong)IND申请(qing)(qing))537件(jian)(jian),较2019年增(zeng)长58.88%;完(wan)成(cheng)(cheng)预防(fang)用(yong)(yong)生物(wu)制(zhi)品(pin)NDA(预防(fang)用(yong)(yong)NDA)9件(jian)(jian),完(wan)成(cheng)(cheng)治(zhi)疗用(yong)(yong)生物(wu)制(zhi)品(pin)NDA(治(zhi)疗用(yong)(yong)NDA)108件(jian)(jian),完(wan)成(cheng)(cheng)体(ti)外诊断试(shi)剂NDA(体(ti)外诊断NDA)1件(jian)(jian)。2020年生物(wu)制(zhi)品(pin)各(ge)类注(zhu)册(ce)申请(qing)(qing)的(de)审(shen)评完(wan)成(cheng)(cheng)情况详见图11。

 

2.审评(ping)通过(guo)情况

药(yao)审(shen)中(zhong)心审(shen)评(ping)通过(guo)批(pi)准生物制品IND申请(qing)500件(jian)(jian)(jian),较(jiao)(jiao)2019年(nian)增(zeng)(zeng)(zeng)长60.26%。其中(zhong),预防用(yong)(yong)IND申请(qing)19件(jian)(jian)(jian);治疗(liao)用(yong)(yong)IND申请(qing)481件(jian)(jian)(jian),较(jiao)(jiao)2019年(nian)增(zeng)(zeng)(zeng)长63.61%。审(shen)评(ping)通过(guo)生物制品NDA 89件(jian)(jian)(jian),较(jiao)(jiao)2019年(nian)增(zeng)(zeng)(zeng)长20.27%。其中(zhong),预防用(yong)(yong)NDA 7件(jian)(jian)(jian);治疗(liao)用(yong)(yong)NDA 81件(jian)(jian)(jian)(制剂77件(jian)(jian)(jian)),较(jiao)(jiao)2019年(nian)增(zeng)(zeng)(zeng)长19.12%;体外诊(zhen)断NDA 1件(jian)(jian)(jian)。2020年(nian)生物制品各类注册申请(qing)审(shen)评(ping)完(wan)成(cheng)的具(ju)体情(qing)况详见(jian)表4,2016-2020年(nian)审(shen)评(ping)通过(guo)批(pi)准生物制品IND申请(qing)和(he)审(shen)评(ping)通过(guo)NDA情(qing)况详见(jian)图12。

 

 

药审(shen)(shen)中(zhong)心(xin)审(shen)(shen)评(ping)通(tong)过批准生物制(zhi)品IND申(shen)请500件,2020年(nian)(nian)审(shen)(shen)评(ping)通(tong)过批准的生物制(zhi)品IND申(shen)请适(shi)应(ying)症(zheng)分布详见图13。药审(shen)(shen)中(zhong)心(xin)审(shen)(shen)评(ping)通(tong)过生物制(zhi)品NDA 89件,2020年(nian)(nian)审(shen)(shen)评(ping)通(tong)过的生物制(zhi)品NDA适(shi)应(ying)症(zheng)分布详见图14。

 

 

(五)行政审批注册申请(qing)完成情况

1.总体情况

2020年(nian)(nian),药(yao)审(shen)中(zhong)心(xin)完(wan)成(cheng)(cheng)中(zhong)药(yao)、化(hua)学药(yao)、生(sheng)物制品各(ge)类注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)行(xing)政(zheng)审(shen)批(pi)(pi)共8646件,较2019年(nian)(nian)增长44.51%。其(qi)中(zhong),完(wan)成(cheng)(cheng)审(shen)评(ping)审(shen)批(pi)(pi)的(de)注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)(临床试验(yan)申(shen)(shen)(shen)请(qing)(qing)、一(yi)致性(xing)评(ping)价申(shen)(shen)(shen)请(qing)(qing)、补充申(shen)(shen)(shen)请(qing)(qing)、境外生(sheng)产药(yao)品再注(zhu)册(ce)及复审(shen))5674件,较2019年(nian)(nian)增长39.24%;完(wan)成(cheng)(cheng)直接行(xing)政(zheng)审(shen)批(pi)(pi)的(de)注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)(无需(xu)技术审(shen)评(ping)的(de)补充申(shen)(shen)(shen)请(qing)(qing)、临时(shi)进口申(shen)(shen)(shen)请(qing)(qing))2972件,较2019年(nian)(nian)增长55.77%。2020年(nian)(nian)中(zhong)药(yao)、化(hua)学药(yao)、生(sheng)物制品各(ge)类注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)行(xing)政(zheng)审(shen)批(pi)(pi)完(wan)成(cheng)(cheng)情(qing)况见表5。2018-2020年(nian)(nian)行(xing)政(zheng)审(shen)批(pi)(pi)注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)完(wan)成(cheng)(cheng)情(qing)况详(xiang)见图15。

 

 

2.需审评审批的注册(ce)申请完成情况

药审中心(xin)完成的需审评(ping)审批的5674件(jian)注(zhu)册申(shen)请(qing)中,临床(chuang)试验申(shen)请(qing)1686件(jian)(含验证性临床(chuang)),较(jiao)2019年(nian)(nian)增长(zhang)50.00%;一致性评(ping)价申(shen)请(qing)623件(jian),较(jiao)2019年(nian)(nian)增长(zhang)80.58%;补充申(shen)请(qing)2860件(jian),较(jiao)2019年(nian)(nian)增长(zhang)34.46%;境外生产药品再注(zhu)册478件(jian)、复审27件(jian)。

3.直接行政(zheng)审批(pi)的注册申(shen)请(qing)完成情况

药审(shen)中心完成直接行政审(shen)批的2972件(jian)注(zhu)册申(shen)请(qing)中,按注(zhu)册申(shen)请(qing)类型划分,补充申(shen)请(qing)2537件(jian)、临时进口申(shen)请(qing)435件(jian)。按药品(pin)类型划分,中药153件(jian)、化(hua)学药2411件(jian)、生物(wu)制品(pin)408件(jian)。

(六)注册申请不(bu)批(pi)准的主要原因及存在的问题

2020年,中药(yao)(yao)、化学药(yao)(yao)、生物制(zhi)品(pin)各(ge)类药(yao)(yao)品(pin)注(zhu)册(ce)(ce)申请因(yin)申报资(zi)料无法证明药(yao)(yao)品(pin)安(an)全(quan)性、有(you)效性或者质量可控性,以及未能按期提交补充(chong)资(zi)料等(deng)情(qing)形,导致审(shen)评结论为建(jian)议(yi)不(bu)批准的共(gong)367件(jian)。通过系统(tong)梳理上述注(zhu)册(ce)(ce)申请不(bu)批准原因(yin),从新药(yao)(yao)、仿制(zhi)药(yao)(yao)等(deng)不(bu)同注(zhu)册(ce)(ce)分类角(jiao)度分析药(yao)(yao)品(pin)注(zhu)册(ce)(ce)申请在研发和申报过程(cheng)中存在的主要问(wen)题包(bao)括:

1.新(xin)药申请

IND申(shen)请和(he)研(yan)发(fa)中存(cun)在的(de)问题主要有:正(zheng)式(shi)申(shen)报前未(wei)开展沟(gou)通交(jiao)流;开发(fa)立题依据不(bu)足,成药(yao)(yao)性存(cun)在严重缺(que)陷;申(shen)报资料不(bu)足以(yi)支持开展药(yao)(yao)物临(lin)床(chuang)(chuang)试(shi)验(yan)(yan)或者(zhe)不(bu)能保障临(lin)床(chuang)(chuang)受试(shi)者(zhe)安全。具体表现包括(kuo):未(wei)沟(gou)通交(jiao)流致使申(shen)报后发(fa)现研(yan)究(jiu)信息(xi)严重缺(que)项,无法在时限内完(wan)成补充研(yan)究(jiu);已(yi)有的(de)研(yan)究(jiu)结(jie)果提示(shi)药(yao)(yao)效作用弱,毒性大(da),临(lin)床(chuang)(chuang)获益和(he)风险比值不(bu)合理(li);临(lin)床(chuang)(chuang)开发(fa)定位违背(bei)临(lin)床(chuang)(chuang)诊疗、用药(yao)(yao)的(de)基本原则;已(yi)有的(de)药(yao)(yao)学、临(lin)床(chuang)(chuang)前研(yan)究(jiu)不(bu)符(fu)合临(lin)床(chuang)(chuang)试(shi)验(yan)(yan)要求(qiu);临(lin)床(chuang)(chuang)试(shi)验(yan)(yan)方案(an)整体设计严重缺(que)陷,风险控制措施不(bu)足;联合用药(yao)(yao)的(de)非临(lin)床(chuang)(chuang)研(yan)究(jiu)数据不(bu)充分(fen);联合疫苗(miao)中单苗(miao)的(de)数据不(bu)充分(fen)和(he)/或免疫程序不(bu)一致。

NDA研(yan)(yan)发(fa)(fa)和申(shen)报中存在(zai)的问题主要有:研(yan)(yan)究质量控制和管理存在(zai)缺陷(xian)(xian),导致已有的研(yan)(yan)究结果不能证(zheng)明药品安(an)全(quan)性(xing)(xing)(xing)、有效性(xing)(xing)(xing)和质量可控性(xing)(xing)(xing);违反合(he)规性(xing)(xing)(xing)要求。具体(ti)表现(xian)包括:关(guan)键临床(chuang)研(yan)(yan)究设计存在(zai)重大缺陷(xian)(xian),无(wu)法得出客(ke)观、有力的有效性(xing)(xing)(xing)、安(an)全(quan)性(xing)(xing)(xing)证(zheng)据;药学研(yan)(yan)究存在(zai)严重缺陷(xian)(xian),无(wu)法证(zheng)明产品的质量可控性(xing)(xing)(xing);各开发(fa)(fa)阶段(duan)的研(yan)(yan)究受试样品不一致;注册核查中发(fa)(fa)现(xian)临床(chuang)试验数据存在(zai)真(zhen)实性(xing)(xing)(xing)问题。

2.仿(fang)制药申请

仿(fang)制(zhi)(zhi)药(yao)(yao)一(yi)致性评价申(shen)请(qing)和上市(shi)申(shen)请(qing)中(zhong)存(cun)在(zai)(zai)的问题主要有:仿(fang)制(zhi)(zhi)药(yao)(yao)研发立题不合(he)理;申(shen)报(bao)资料(liao)无法证明(ming)(ming)仿(fang)制(zhi)(zhi)药(yao)(yao)与参比制(zhi)(zhi)剂(ji)(被仿(fang)制(zhi)(zhi)药(yao)(yao)品)的质量一(yi)致性。具体(ti)表(biao)现包括(kuo):仿(fang)制(zhi)(zhi)药(yao)(yao)的参比制(zhi)(zhi)剂(ji)已撤市(shi),且已有更新换(huan)代安全性更好的产品满足临床需求;样品复核检验不符(fu)合(he)规定或分(fen)析方(fang)法存(cun)在(zai)(zai)严重缺陷;人体(ti)生物(wu)等效(xiao)性试验结果(guo)表(biao)明(ming)(ming)不等效(xiao);样品稳定性研究结果(guo)、原料(liao)药(yao)(yao)起始物(wu)料(liao)选择等不符(fu)合(he)仿(fang)制(zhi)(zhi)药(yao)(yao)上市(shi)技术(shu)要求;仿(fang)制(zhi)(zhi)药(yao)(yao)未(wei)按规定使用(yong)具有合(he)法来(lai)源的原料(liao)药(yao)(yao)。

3.补(bu)充(chong)申请

补(bu)充申(shen)(shen)(shen)请研究和申(shen)(shen)(shen)报中存在的问题主要有:申(shen)(shen)(shen)请资料未能充分(fen)说(shuo)明变(bian)(bian)(bian)更(geng)的科学性(xing)(xing)和合理性(xing)(xing),不(bu)足以支(zhi)持变(bian)(bian)(bian)更(geng)事项(xiang);已有的研究结(jie)果不(bu)能保证变(bian)(bian)(bian)更(geng)后产(chan)品(pin)(pin)的安全(quan)性(xing)(xing)、有效(xiao)性(xing)(xing)和质(zhi)(zhi)量可控性(xing)(xing)。具体表(biao)现包(bao)括(kuo):变(bian)(bian)(bian)更(geng)引(yin)起(qi)药用物质(zhi)(zhi)基础发生重大改变(bian)(bian)(bian);药品(pin)(pin)说(shuo)明书修改申(shen)(shen)(shen)请不(bu)符合说(shuo)明书撰写的技术要求;用于支(zhi)持变(bian)(bian)(bian)更(geng)的文献资料存在偏(pian)倚,或者(zhe)临床安全(quan)性(xing)(xing)和有效(xiao)性(xing)(xing)数据不(bu)充分(fen)。

4.其(qi)他

其他药品注册申(shen)请在(zai)研发和申(shen)报中(zhong)存在(zai)的(de)问题主要(yao)有:生(sheng)(sheng)物(wu)类(lei)似(si)药开(kai)发缺少相(xiang)似(si)性(xing)比较(jiao)数据(ju),药学比对(dui)研究(jiu)中(zhong)参照药选择存在(zai)缺陷(xian);生(sheng)(sheng)物(wu)类(lei)似(si)药临(lin)床前研究(jiu)结果不足以(yi)支持(chi)其开(kai)展(zhan)临(lin)床试验;天然药物(wu)的(de)研究(jiu)资料不符(fu)合国际多中(zhong)心(xin)临(lin)床试验或我国天然药物(wu)评(ping)价(jia)基本技术要(yao)求。

(七)药品加快上(shang)市注册程序情况

创新(xin)是推(tui)动药(yao)(yao)(yao)品(pin)高质量发展的(de)力量源泉,《药(yao)(yao)(yao)品(pin)注册管理办法》结合我(wo)国(guo)医药(yao)(yao)(yao)产业发展和(he)临床需求实(shi)际(ji),参考国(guo)际(ji)经验,设立了(le)特(te)别审(shen)批(pi)、突(tu)(tu)破性(xing)(xing)治(zhi)疗药(yao)(yao)(yao)物(wu)(wu)、附(fu)条件(jian)批(pi)准、优先审(shen)评(ping)审(shen)批(pi)四个药(yao)(yao)(yao)品(pin)加(jia)(jia)快上市(shi)程序(xu)。《国(guo)家药(yao)(yao)(yao)监局关于发布<突(tu)(tu)破性(xing)(xing)治(zhi)疗药(yao)(yao)(yao)物(wu)(wu)审(shen)评(ping)工(gong)作(zuo)程序(xu)(试行(xing))>等(deng)三个文件(jian)的(de)公告》(2020年第82号),明确了(le)加(jia)(jia)快通(tong)道的(de)适用范(fan)围、适用条件(jian)、工(gong)作(zuo)程序(xu)和(he)政策(ce)支持等(deng),既(ji)能显著(zhu)提高相关程序(xu)执行(xing)过程中的(de)可(ke)操作(zuo)性(xing)(xing),鼓励药(yao)(yao)(yao)物(wu)(wu)研制和(he)创新(xin),又能在全球抗(kang)击疫(yi)情(qing)(qing)的(de)大背景下(xia),依(yi)法依(yi)规对疫(yi)情(qing)(qing)防(fang)控(kong)所需药(yao)(yao)(yao)物(wu)(wu)实(shi)行(xing)特(te)别审(shen)批(pi),对于加(jia)(jia)快临床急(ji)需、临床价值突(tu)(tu)出、公共卫(wei)生急(ji)需等(deng)药(yao)(yao)(yao)物(wu)(wu)的(de)上市(shi)具有重要推(tui)动作(zuo)用。2020年已批(pi)准上市(shi)药(yao)(yao)(yao)品(pin)纳入加(jia)(jia)快上市(shi)程序(xu)情(qing)(qing)况详见附(fu)件(jian)4。

1.特别审批药物情况

在发生突发公共卫生事(shi)件(jian)的威(wei)胁时以及突发公共卫生事(shi)件(jian)发生后,国(guo)家(jia)药(yao)监局可依法决定(ding)对突发公共卫生事(shi)件(jian)应急所需防治药(yao)品(pin)实(shi)行(xing)特别审批(pi)。纳入实(shi)施特别审批(pi)程序的药(yao)物,国(guo)家(jia)药(yao)监局按照统一(yi)(yi)指挥、早期(qi)介入、快速高(gao)效、科学审批(pi)的原则,组(zu)织加快并(bing)同(tong)步开展药(yao)品(pin)注册受理(li)、审评(ping)、核查、检验工作,并(bing)根据疾(ji)病防控(kong)的特定(ding)需要,限定(ding)其在一(yi)(yi)定(ding)的期(qi)限和范围内使用。

2020年新(xin)(xin)冠肺(fei)炎(yan)(yan)疫(yi)(yi)情(qing)在全球范围内不(bu)断蔓延,人民(min)群众(zhong)的(de)(de)生命安全受到严重威胁,药(yao)审中心(xin)闻(wen)令而动(dong),第一时间科(ke)学、高效(xiao)推(tui)进特(te)别审评(ping)工作,按程序将(jiang)59件(jian)(jian)中药(yao)、化学药(yao)、生物制品注册申请(qing)纳(na)入特(te)别审批(pi)(pi)程序并(bing)完成技术审评(ping)。建议(yi)附条(tiao)件(jian)(jian)批(pi)(pi)准上市(shi)(shi)1件(jian)(jian),为(wei)新(xin)(xin)型(xing)冠状病毒灭活疫(yi)(yi)苗(miao)(Vero细胞);建议(yi)批(pi)(pi)准临(lin)(lin)床试验申请(qing)53件(jian)(jian),其中5件(jian)(jian)已进入Ⅲ期临(lin)(lin)床试验,批(pi)(pi)准化湿败毒颗粒、清肺(fei)排毒颗粒的(de)(de)临(lin)(lin)床试验申请(qing);批(pi)(pi)准了连花清瘟胶囊/颗粒、金花清感颗粒及(ji)血必净注射液等5件(jian)(jian)增加适(shi)应(ying)症的(de)(de)补(bu)充申请(qing),加速(su)了新(xin)(xin)冠病毒疫(yi)(yi)苗(miao)和新(xin)(xin)冠肺(fei)炎(yan)(yan)治疗药(yao)物的(de)(de)上市(shi)(shi)进程,初步(bu)满足了新(xin)(xin)冠肺(fei)炎(yan)(yan)疫(yi)(yi)情(qing)防控的(de)(de)需要。

2.突破性治疗药物情况

突(tu)(tu)破性(xing)治(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)指(zhi)(zhi)的(de)(de)是(shi)(shi)(shi)用于(yu)防治(zhi)(zhi)严重危及(ji)生命或者(zhe)严重影(ying)响生存质量的(de)(de)疾病,且尚无有效防治(zhi)(zhi)手段(duan)(duan)或者(zhe)与(yu)现有治(zhi)(zhi)疗(liao)手段(duan)(duan)相比有足够证据(ju)(ju)表(biao)明具有明显临床(chuang)优势的(de)(de)创新(xin)药(yao)(yao)(yao)或者(zhe)改良型新(xin)药(yao)(yao)(yao)等,申(shen)(shen)请(qing)人可在(zai)Ⅰ、Ⅱ临床(chuang)试(shi)验阶段(duan)(duan)申(shen)(shen)请(qing)适(shi)用突(tu)(tu)破性(xing)治(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)程序。根据(ju)(ju)《突(tu)(tu)破性(xing)治(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)审(shen)评(ping)(ping)工(gong)作(zuo)程序(试(shi)行)》,纳入到(dao)“突(tu)(tu)破性(xing)治(zhi)(zhi)疗(liao)”审(shen)评(ping)(ping)通道的(de)(de)药(yao)(yao)(yao)物(wu),药(yao)(yao)(yao)审(shen)中(zhong)(zhong)心(xin)一是(shi)(shi)(shi)会优先(xian)处理相关沟通交(jiao)流,加强指(zhi)(zhi)导并促进药(yao)(yao)(yao)物(wu)研(yan)发进程;二是(shi)(shi)(shi)在(zai)申(shen)(shen)报上市环节,该药(yao)(yao)(yao)物(wu)可适(shi)用优先(xian)审(shen)评(ping)(ping)审(shen)批程序,审(shen)评(ping)(ping)时限进一步缩(suo)短;三是(shi)(shi)(shi)上市申(shen)(shen)请(qing)阶段(duan)(duan),药(yao)(yao)(yao)审(shen)中(zhong)(zhong)心(xin)会滚动(dong)接收其申(shen)(shen)报资料,并优先(xian)安排核查、检(jian)验等,可大大缩(suo)减新(xin)药(yao)(yao)(yao)从研(yan)发到(dao)上市的(de)(de)时间。2020年药(yao)(yao)(yao)审(shen)中(zhong)(zhong)心(xin)收到(dao)147件(jian)突(tu)(tu)破性(xing)治(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)申(shen)(shen)请(qing)。经综(zong)合(he)评(ping)(ping)估、公示,已将24件(jian)突(tu)(tu)破性(xing)治(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)申(shen)(shen)请(qing)(21个品(pin)种)纳入突(tu)(tu)破性(xing)治(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)程序,详(xiang)见(jian)附(fu)件(jian)5。

3.附条(tiao)件批准药物情况(kuang)

附(fu)条件批准(zhun)上市(shi)(shi),目的在于(yu)缩短药物(wu)(wu)(wu)临床(chuang)试验(yan)的研发时间,使(shi)(shi)其尽(jin)早应用(yong)于(yu)无法继续等待的危重疾(ji)病(bing)或公共卫生(sheng)方面急需的患者。药物(wu)(wu)(wu)有效性(xing)评价的指标(biao)为临床(chuang)终点,符合附(fu)条件批准(zhun)上市(shi)(shi)情形的药物(wu)(wu)(wu),可使(shi)(shi)用(yong)替(ti)代终点、中间临床(chuang)终点或早期临床(chuang)试验(yan)数(shu)据来反映药物(wu)(wu)(wu)的有效性(xing),当这些数(shu)据能够提(ti)示药品的获(huo)益大(da)于(yu)风险(xian)时候,即可申(shen)请附(fu)条件批准(zhun)上市(shi)(shi)。

对于若不(bu)尽早进(jin)行治疗则(ze)会(hui)在数月或(huo)者(zhe)更短时间内导致死亡(wang)的(de)(de)疾病(bing)患者(zhe)来说,附条(tiao)(tiao)件(jian)批(pi)准上市(shi)(shi)(shi)的(de)(de)药(yao)物,使得这(zhei)些无法继续等待的(de)(de)患者(zhe)能够延续生命、提高生存(cun)质量,消除(chu)重大突发公共卫(wei)生事件(jian)对于人民生命安全的(de)(de)威胁。2020年药(yao)审(shen)中心审(shen)评(ping)通过(guo)的(de)(de)新药(yao)上市(shi)(shi)(shi)申(shen)请中,共有15件(jian)注册申(shen)请经附条(tiao)(tiao)件(jian)批(pi)准后上市(shi)(shi)(shi),覆盖(gai)了(le)新型冠(guan)状病(bing)毒感染引起的(de)(de)疾病(bing)、非小(xiao)细胞肺癌、卵巢癌等适应(ying)症。

4.优先审评药物情(qing)况

(1)优先审评(ping)品(pin)种纳入情况(kuang)

《药(yao)(yao)(yao)品注册管理(li)办法》对优先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)程(cheng)序(xu)(xu)(xu)(xu)的(de)调整,是在多(duo)年实践经(jing)验基础上的(de)优化,一(yi)是适用范围更多(duo)地向具有明显(xian)临床价(jia)值(zhi)、临床急(ji)需(xu)和临床优势(shi)的(de)药(yao)(yao)(yao)物聚焦,致力(li)于将更多(duo)的(de)临床价(jia)值(zhi)显(xian)著、临床急(ji)需(xu)的(de)短缺药(yao)(yao)(yao)品、防治重大传染病、罕(han)见病、儿童(tong)用药(yao)(yao)(yao)、纳(na)入(ru)突破(po)性治疗程(cheng)序(xu)(xu)(xu)(xu)、符合附条(tiao)件批(pi)(pi)准(zhun)的(de)药(yao)(yao)(yao)品等(deng)纳(na)入(ru)优先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)程(cheng)序(xu)(xu)(xu)(xu);二是审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)时(shi)(shi)限的(de)加速,药(yao)(yao)(yao)品上市许可申请(qing)的(de)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)时(shi)(shi)限一(yi)般为200个(ge)工(gong)作日(ri),与完(wan)整的(de)申报(bao)路径相比,优先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)程(cheng)序(xu)(xu)(xu)(xu)的(de)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)时(shi)(shi)限缩短至130个(ge)工(gong)作日(ri),其中(zhong)临床急(ji)需(xu)境外已上市罕(han)见病用药(yao)(yao)(yao)优先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)程(cheng)序(xu)(xu)(xu)(xu)的(de)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)时(shi)(shi)限为70个(ge)工(gong)作日(ri)。药(yao)(yao)(yao)审(shen)(shen)(shen)(shen)中(zhong)心通过优化审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)资源配(pei)置率,在高标(biao)准(zhun)完(wan)成技术审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)的(de)前提(ti)下,力(li)争按时(shi)(shi)限完(wan)成审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping),推动纳(na)入(ru)优先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)程(cheng)序(xu)(xu)(xu)(xu)中(zhong)的(de)品种尽快获批(pi)(pi)上市。

根据(ju)《药品(pin)注(zhu)册(ce)(ce)管(guan)理(li)办(ban)法》、46号(hao)公告、《国家食品(pin)药品(pin)监督管(guan)理(li)总局关于(yu)鼓励(li)药品(pin)创新实行优(you)先(xian)审(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)批(pi)的(de)意见》(食药监药化管(guan)〔2017〕126号(hao),以(yi)下简称(cheng)126号(hao)文(wen)件(jian)),2020年药审(shen)(shen)(shen)(shen)(shen)中(zhong)心将219件(jian)(按通(tong)用(yong)(yong)(yong)名计127个品(pin)种)注(zhu)册(ce)(ce)申(shen)请纳入优(you)先(xian)审(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)批(pi)程(cheng)(cheng)序(xu)。其中(zhong),144件(jian)注(zhu)册(ce)(ce)申(shen)请按照(zhao)126号(hao)文(wen)件(jian)规(gui)定的(de)范围纳入优(you)先(xian)审(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)批(pi)程(cheng)(cheng)序(xu),75件(jian)按照(zhao)《药品(pin)注(zhu)册(ce)(ce)管(guan)理(li)办(ban)法》规(gui)定的(de)范围纳入优(you)先(xian)审(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)批(pi)程(cheng)(cheng)序(xu),包(bao)括42件(jian)儿童用(yong)(yong)(yong)药和(he)罕见病用(yong)(yong)(yong)药。2016-2020年纳入优(you)先(xian)审(shen)(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)(shen)批(pi)程(cheng)(cheng)序(xu)的(de)各类注(zhu)册(ce)(ce)申(shen)请情况详(xiang)见表(biao)6和(he)表(biao)7。

   

 

 

  按此前优(you)先审(shen)评范围纳(na)入的(de)注册申请中,同(tong)步(bu)申报(bao)占(zhan)比多达44%(64/144),具有明显临床价值的(de)新(xin)药占(zhan)比为20%,按与原研(yan)药质(zhi)量和疗效(xiao)一(yi)致的(de)标准完善后重新(xin)申报(bao)品种占(zhan)比则由(you)7.9%降至4.2%。

按(an)照《药品注册(ce)管(guan)理办法》优先(xian)审评(ping)(ping)范围纳入的注册(ce)申请中,符合附条(tiao)件(jian)批(pi)准的药品占比(bi)为36%(27/75),创(chuang)新(xin)药和(he)儿童用药占比(bi)28%(21/75),优先(xian)审评(ping)(ping)资(zi)源(yuan)已向(xiang)具有(you)明显(xian)临床价(jia)值的创(chuang)新(xin)、急需药物倾斜。

(2)优先审评品种完成情况

2020年有217件(jian)注册申请(按(an)通用名计121个(ge)品(pin)种)通过优先审(shen)评(ping)程序建议批准上(shang)市(含已(yi)上(shang)市药(yao)(yao)(yao)品(pin)新(xin)增适应(ying)症),审(shen)评(ping)通过件(jian)数较2019年增长51.7%,例如:我国自(zi)主(zhu)研发的1类创新(xin)药(yao)(yao)(yao)甲磺酸阿(a)(a)美替尼(ni)片(pian)、泽布(bu)替尼(ni)胶(jiao)囊、奥(ao)布(bu)替尼(ni)片(pian)等,治(zhi)疗(liao)罕见病(bing)法(fa)布(bu)雷病(bing)阿(a)(a)加(jia)糖酶α注射用浓(nong)溶液,用于(yu)配合饮食(shi)控制(zhi)及(ji)运动(dong)治(zhi)疗(liao)2型糖尿病(bing)的中药(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)桑枝总生物(wu)碱(jian)片(pian)、间(jian)变性(xing)淋巴瘤(liu)激酶抑制(zhi)剂盐酸恩沙替尼(ni)胶(jiao)囊、成人复发型多发性(xing)硬化治(zhi)疗(liao)药(yao)(yao)(yao)物(wu)西尼(ni)莫(mo)德(de)片(pian)等。2016-2020年优先审(shen)评(ping)通过的品(pin)种情(qing)况详见表8。

 

(八)药品(pin)注册现场(chang)核查相(xiang)关情况

1.总体情况

药(yao)审中心(xin)积极落实《药(yao)品注(zhu)册(ce)(ce)管理办法》,转变药(yao)品注(zhu)册(ce)(ce)核(he)(he)查(cha)(cha)理念,将注(zhu)册(ce)(ce)现场(chang)核(he)(he)查(cha)(cha)启(qi)动工作模式(shi)由基(ji)于(yu)(yu)审评需要调整为基(ji)于(yu)(yu)风险启(qi)动,并联开展技(ji)术审评与注(zhu)册(ce)(ce)现场(chang)核(he)(he)查(cha)(cha)工作;对于(yu)(yu)自2020年7月1日起(qi)受(shou)理的注(zhu)册(ce)(ce)申请,在受(shou)理后40个工作日内决(jue)定是(shi)否启(qi)动相应(ying)注(zhu)册(ce)(ce)现场(chang)核(he)(he)查(cha)(cha)任务(wu)。为便于(yu)(yu)申请人及时获(huo)知(zhi)注(zhu)册(ce)(ce)现场(chang)核(he)(he)查(cha)(cha)启(qi)动相关信息,完善药(yao)审中心(xin)网站申请人之窗栏(lan)目,开通(tong)递交注(zhu)册(ce)(ce)现场(chang)核(he)(he)查(cha)(cha)用生产工艺与质量标准通(tong)道(dao)和查(cha)(cha)收注(zhu)册(ce)(ce)现场(chang)核(he)(he)查(cha)(cha)电(dian)子通(tong)知(zhi)函的功能。

2.注册现场核查具体情况

2020年(nian),药审中心(xin)基于品种因(yin)素和(he)研(yan)发生产(chan)主(zhu)体合规因(yin)素风险启(qi)动注册现场(chang)核(he)(he)查(cha)任务1235个。其中,药学现场(chang)核(he)(he)查(cha)任务792个,临(lin)床(chuang)试验数据核(he)(he)查(cha)任务439个,药理(li)毒理(li)研(yan)究核(he)(he)查(cha)任务4个。

药(yao)审中心接收(shou)核(he)(he)(he)查(cha)(cha)(cha)报(bao)告818份(fen)。其中,药(yao)学(xue)现(xian)场核(he)(he)(he)查(cha)(cha)(cha)报(bao)告449份(fen),临(lin)床试验(yan)核(he)(he)(he)查(cha)(cha)(cha)报(bao)告363份(fen),药(yao)理(li)(li)毒理(li)(li)研究核(he)(he)(he)查(cha)(cha)(cha)报(bao)告6份(fen)。

(九)沟通交(jiao)流情况

1.总体情况

2020年(nian),药(yao)(yao)(yao)审中(zhong)(zhong)心(xin)在落实疫(yi)(yi)情防控要求的(de)同时,尽量满足(zu)申(shen)(shen)请(qing)(qing)人(ren)(ren)的(de)需(xu)要,全力保障各类(lei)沟通(tong)交(jiao)流畅通(tong)。在推动(dong)新(xin)冠(guan)(guan)病毒(du)(du)疫(yi)(yi)苗和(he)新(xin)冠(guan)(guan)肺炎治疗(liao)药(yao)(yao)(yao)物的(de)研发方(fang)面,为79个(ge)新(xin)冠(guan)(guan)病毒(du)(du)疫(yi)(yi)苗,中(zhong)(zhong)医药(yao)(yao)(yao)、中(zhong)(zhong)和(he)抗(kang)体(27个(ge))等新(xin)冠(guan)(guan)肺炎治疗(liao)药(yao)(yao)(yao)物,组(zu)织(zhi)申(shen)(shen)请(qing)(qing)人(ren)(ren)与药(yao)(yao)(yao)审中(zhong)(zhong)心(xin)审评团队之间的(de)沟通(tong)交(jiao)流5600余次,并针对(dui)新(xin)冠(guan)(guan)病毒(du)(du)疫(yi)(yi)苗、中(zhong)(zhong)和(he)抗(kang)体等重点品种,单独设(she)立(li)了(le)台(tai)账(zhang),动(dong)态跟进(jin);在维护(hu)与申(shen)(shen)请(qing)(qing)人(ren)(ren)沟通(tong)桥梁方(fang)面,药(yao)(yao)(yao)审中(zhong)(zhong)心(xin)发布了(le)《药(yao)(yao)(yao)物研发与技术审评沟通(tong)交(jiao)流管理办法》《药(yao)(yao)(yao)审中(zhong)(zhong)心(xin)关于业务咨询(xun)服务联络方(fang)式(shi)的(de)通(tong)知》,优(you)化了(le)电(dian)(dian)话咨询(xun)服务,每天有(you)专人(ren)(ren)接听(ting)解(jie)答申(shen)(shen)请(qing)(qing)人(ren)(ren)咨询(xun)电(dian)(dian)话,根据咨询(xun)问题类(lei)型(xing)的(de)不同设(she)立(li)了(le)8个(ge)联系邮(you)箱,及时解(jie)答处理申(shen)(shen)请(qing)(qing)人(ren)(ren)问题,不断提高沟通(tong)交(jiao)流的(de)质量和(he)效率(lv)。

药审(shen)中心接收沟(gou)通交(jiao)流(liu)会议申请3229件,较2019年(nian)增(zeng)长22.64%,办理沟(gou)通交(jiao)流(liu)会议申请2451件,较2019年(nian)增(zeng)长31.00%。在网络平(ping)台接收一(yi)般(ban)性技(ji)术问(wen)题(ti)咨询20285个,较2019年(nian)增(zeng)长22.41%;接收电话咨询超过上万次,邮件咨询数千件,同时(shi)也面向(xiang)社会提供现场咨询服(fu)务。2016-2020年(nian)接收沟(gou)通交(jiao)流(liu)申请和一(yi)般(ban)性技(ji)术问(wen)题(ti)咨询具体情况详见图(tu)16。

 

2.沟通交流会(hui)议(yi)申请的完成情况

药(yao)审中心所接收(shou)的(de)3229件沟通交(jiao)(jiao)流会议(yi)申请中,符合会议(yi)召(zhao)(zhao)开条件的(de),及(ji)时(shi)与申请人取得了联系(xi),商议(yi)会议(yi)细节;无需召(zhao)(zhao)开会议(yi)的(de),以书面形(xing)式尽快回复(fu)了申请人。2020年共办(ban)理了2451件沟通交(jiao)(jiao)流会议(yi)申请。在药(yao)物(wu)研发关键阶段召(zhao)(zhao)开的(de)Ⅱ类(lei)会议(yi)占比76.42%,其中临(lin)床前(Pre-IND)申请占比37.49%。2020年各类(lei)沟通交(jiao)(jiao)流会议(yi)申请及(ji)办(ban)理情(qing)况详见表(biao)9。

 

  沟通交(jiao)流(liu)会议(yi)(yi)(yi)的(de)形式为电话(hua)会议(yi)(yi)(yi)、视频(pin)会议(yi)(yi)(yi)、面(mian)对面(mian)会议(yi)(yi)(yi),共(gong)召开沟通交(jiao)流(liu)会议(yi)(yi)(yi)268次(ci),以书面(mian)形式回复两千余(yu)件。2018-2020年各类沟通交(jiao)流(liu)会议(yi)(yi)(yi)的(de)召开情况详见表10。

 

3.一般性技术问题答复情况

药(yao)审中心通过网(wang)上咨询平台共接收了20285个一般(ban)性(xing)技术问(wen)题的咨询。按照内容分(fen)类,问(wen)题主要(yao)集中于(yu)受(shou)理(4038个)、原辅(fu)包(3952个)等方(fang)面(mian)(mian);按照药(yao)品分(fen)类,问(wen)题主要(yao)集中于(yu)化学(xue)(xue)药(yao)(11338个)方(fang)面(mian)(mian),其中化学(xue)(xue)药(yao)受(shou)理(2396个)、化学(xue)(xue)药(yao)一致性(xing)评价(jia)(1258个)。一般(ban)性(xing)技术问(wen)题答复(fu)具体情况详见表11。

 

二(er)、药品注册申请受(shou)理情况

(一)总体情(qing)况

2020年(nian),根(gen)据46号公告(gao)、《国家(jia)药(yao)(yao)监局(ju)关(guan)于发布(bu)生物制(zhi)品注(zhu)册(ce)分类(lei)(lei)及(ji)申(shen)(shen)(shen)报(bao)资料要(yao)求(qiu)的(de)通(tong)告(gao)》(2020年(nian)第(di)43号)、《国家(jia)药(yao)(yao)监局(ju)关(guan)于发布(bu)化(hua)学药(yao)(yao)品注(zhu)册(ce)分类(lei)(lei)及(ji)申(shen)(shen)(shen)报(bao)资料要(yao)求(qiu)的(de)通(tong)告(gao)》(2020年(nian)第(di)44号)、《国家(jia)药(yao)(yao)监局(ju)关(guan)于发布(bu)<中(zhong)药(yao)(yao)注(zhu)册(ce)分类(lei)(lei)及(ji)申(shen)(shen)(shen)报(bao)资料要(yao)求(qiu)>的(de)通(tong)告(gao)》(2020年(nian)第(di)68号)等(deng),药(yao)(yao)审(shen)(shen)(shen)中(zhong)心(xin)受理中(zhong)药(yao)(yao)、化(hua)学药(yao)(yao)、生物制(zhi)品各类(lei)(lei)注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)共10245件(jian)(含(han)药(yao)(yao)械(xie)组合(he)产品6件(jian)),较(jiao)2019年(nian)增长26.76%。其中(zhong),需(xu)技(ji)术审(shen)(shen)(shen)评的(de)注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)7147件(jian)(含(han)5695件(jian)需(xu)药(yao)(yao)审(shen)(shen)(shen)中(zhong)心(xin)技(ji)术审(shen)(shen)(shen)评和行政审(shen)(shen)(shen)批的(de)注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)),较(jiao)2019年(nian)增长15.29%;直接(jie)行政审(shen)(shen)(shen)批的(de)注(zhu)册(ce)申(shen)(shen)(shen)请(qing)(qing)3092件(jian),较(jiao)2019年(nian)增长64.64%。

受理的10239件药品注(zhu)(zhu)册(ce)(ce)申(shen)请中,化学药注(zhu)(zhu)册(ce)(ce)申(shen)请受理量为7901件,较2019年(nian)增长22.02%,占2020年(nian)全部注(zhu)(zhu)册(ce)(ce)申(shen)请受理量的77.17%,2016-2020年(nian)各(ge)类药品注(zhu)(zhu)册(ce)(ce)申(shen)请受理情况(kuang)详见图17。

 

2.药审中心的直(zhi)接行政审批工作自2017年开始,故(gu)2016年无直(zhi)接行政审批注册(ce)申请,所有受理注册(ce)申请均需技术审评。

2020年(nian)受理的(de)(de)需技术(shu)审(shen)评的(de)(de)注册(ce)申(shen)请(qing)7147件(jian)(jian)(jian)中(zhong)(zhong),化(hua)学药注册(ce)申(shen)请(qing)为5402件(jian)(jian)(jian),较(jiao)2019年(nian)增(zeng)(zeng)长(zhang)9.42%,占全部需技术(shu)审(shen)评的(de)(de)注册(ce)申(shen)请(qing)受理量的(de)(de)75.58%;中(zhong)(zhong)药注册(ce)申(shen)请(qing)315件(jian)(jian)(jian),较(jiao)2019年(nian)增(zeng)(zeng)长(zhang)22.57%;生物制品注册(ce)申(shen)请(qing)1430件(jian)(jian)(jian),较(jiao)2019年(nian)增(zeng)(zeng)长(zhang)42.29%。2016-2020年(nian)需技术(shu)审(shen)评的(de)(de)中(zhong)(zhong)药、化(hua)学药、生物制品各类注册(ce)申(shen)请(qing)受理情(qing)况详见图18。

 

(二)1类创新药受理情况

2020年(nian)(nian),药(yao)(yao)审中(zhong)心受(shou)理1类(lei)(lei)创(chuang)(chuang)新药(yao)(yao)注册申(shen)请共1062件(jian)(597个(ge)(ge)品(pin)(pin)种(zhong)),较(jiao)2019年(nian)(nian)增长(zhang)(zhang)51.71%。其中(zhong),受(shou)理IND申(shen)请1008件(jian)(559个(ge)(ge)品(pin)(pin)种(zhong)),较(jiao)2019年(nian)(nian)增长(zhang)(zhang)49.78%;受(shou)理NDA 54件(jian)(38个(ge)(ge)品(pin)(pin)种(zhong)),较(jiao)2019年(nian)(nian)增长(zhang)(zhang)100.00%。以(yi)药(yao)(yao)品(pin)(pin)类(lei)(lei)别(bie)统计,中(zhong)药(yao)(yao)、化学(xue)药(yao)(yao)、生物(wu)制品(pin)(pin)1类(lei)(lei)创(chuang)(chuang)新药(yao)(yao)受(shou)理量分别(bie)为14、752、296件(jian)。以(yi)生产场(chang)地统计,境内生产药(yao)(yao)品(pin)(pin)843件(jian),境外(wai)生产药(yao)(yao)品(pin)(pin)219件(jian)。详(xiang)见(jian)表12和13。

 

(三)各类注册申(shen)请受理情况

1.中药注册申请受理情况

2020年(nian),药(yao)审中(zhong)心(xin)受理(li)中(zhong)药(yao)注(zhu)册申请(qing)471件。其(qi)中(zhong),受理(li)中(zhong)药(yao)IND申请(qing)22件,受理(li)中(zhong)药(yao)NDA 6件,受理(li)中(zhong)药(yao)ANDA 1件。2020年(nian)中(zhong)药(yao)各(ge)类注(zhu)册申请(qing)受理(li)情(qing)况详(xiang)见(jian)图19。

 

  受理1类中药创新药注册(ce)申(shen)请(qing)14件(jian)。其(qi)中,受理IND 申(shen)请(qing)9件(jian)(9个品(pin)种),受理NDA 5件(jian)(5个品(pin)种)。

2.化(hua)学药注(zhu)册申(shen)请受(shou)理情况

2020年,药(yao)(yao)(yao)审中(zhong)心受(shou)理(li)(li)(li)化学药(yao)(yao)(yao)注册(ce)申(shen)(shen)请(qing)7901。其中(zhong),受(shou)理(li)(li)(li)化学药(yao)(yao)(yao)IND申(shen)(shen)请(qing)946件(jian),较2019年增长(zhang)36.31%;受(shou)理(li)(li)(li)化学药(yao)(yao)(yao)NDA 191件(jian),较2019年增长(zhang)46.92%;受(shou)理(li)(li)(li)ANDA 1125件(jian),较2019年增长(zhang)7.45%;受(shou)理(li)(li)(li)一(yi)致性评(ping)价申(shen)(shen)请(qing)914件(jian),较2019年减少11.95%。2020年化学药(yao)(yao)(yao)各类注册(ce)申(shen)(shen)请(qing)受(shou)理(li)(li)(li)情况(kuang)详见(jian)图(tu)(tu)20。2016-2020年化学药(yao)(yao)(yao)各类注册(ce)申(shen)(shen)请(qing)受(shou)理(li)(li)(li)情况(kuang)详见(jian)图(tu)(tu)21。

 

 

药审(shen)中(zhong)心(xin)受(shou)理1类创新化学药注册申请752件(360个(ge)(ge)品(pin)种(zhong)),较2019年增(zeng)长(zhang)31.24%。其中(zhong),受(shou)理IND申请721件(339个(ge)(ge)品(pin)种(zhong)),较2019年增(zeng)长(zhang)30.62%;受(shou)理NDA 31件(21个(ge)(ge)品(pin)种(zhong)),较2019年增(zeng)长(zhang)47.62%。

药审中心受理化学(xue)药5.1类注册申请(qing)160件,较2019年(nian)增长1.91%。其中受理临床试(shi)验申请(qing)(验证性临床)53件,受理NDA 107件。

360个(ge)品(pin)种的1类创新化学药(yao)注(zhu)(zhu)(zhu)册(ce)申请(qing)中,境内生产化学药(yao)注(zhu)(zhu)(zhu)册(ce)申请(qing)为(wei)(wei)258个(ge)品(pin)种,境外生产化学药(yao)注(zhu)(zhu)(zhu)册(ce)申请(qing)为(wei)(wei)102个(ge)品(pin)种。2016-2020年1类创新化学药(yao)注(zhu)(zhu)(zhu)册(ce)申请(qing)受理情况详见图22。

 

3.生物制(zhi)品注(zhu)册申请受理情况

2020年(nian),药审中(zhong)心(xin)受(shou)(shou)理生(sheng)(sheng)物(wu)(wu)(wu)(wu)制品(pin)注册(ce)(ce)申请1867件(jian)(jian)(jian)。其中(zhong),受(shou)(shou)理生(sheng)(sheng)物(wu)(wu)(wu)(wu)制品(pin)IND申请580件(jian)(jian)(jian)(预(yu)防用IND申请25件(jian)(jian)(jian),治(zhi)疗用IND申请555件(jian)(jian)(jian)),较(jiao)2019年(nian)增(zeng)长87.10%;受(shou)(shou)理生(sheng)(sheng)物(wu)(wu)(wu)(wu)制品(pin)NDA 126件(jian)(jian)(jian)(预(yu)防用NDA 7件(jian)(jian)(jian),治(zhi)疗用NDA 117件(jian)(jian)(jian),体外诊断试剂2件(jian)(jian)(jian)),较(jiao)2019年(nian)增(zeng)长1.62%。2020年(nian)生(sheng)(sheng)物(wu)(wu)(wu)(wu)制品(pin)各类注册(ce)(ce)申请受(shou)(shou)理情(qing)(qing)况详见(jian)图23。2016-2020年(nian)生(sheng)(sheng)物(wu)(wu)(wu)(wu)制品(pin)IND申请和NDA受(shou)(shou)理情(qing)(qing)况详见(jian)图24。

 

 

 

药(yao)审中心受理(li)(li)1类创新生物制品(pin)(pin)注册申(shen)请296件(jian)(jian)(223个品(pin)(pin)种),较(jiao)(jiao)2019年(nian)增长133.07%。其中,受理(li)(li)预防(fang)用(yong)生物制品(pin)(pin)5件(jian)(jian),受理(li)(li)治疗用(yong)生物制品(pin)(pin)291件(jian)(jian);受理(li)(li)生物制品(pin)(pin)IND申(shen)请278件(jian)(jian)(211个品(pin)(pin)种),较(jiao)(jiao)2019年(nian)增长129.75%;受理(li)(li)生物制品(pin)(pin)NDA 18件(jian)(jian)(12个品(pin)(pin)种),较(jiao)(jiao)2019年(nian)增长200.00%,具体情况(kuang)详见表(biao)14。

 

4.行政审批注册申请受理(li)情况(kuang)

(1)总(zong)体情况(kuang)

2020年(nian)(nian),药(yao)(yao)(yao)审(shen)(shen)(shen)(shen)中心(xin)受理需中心(xin)行(xing)(xing)政(zheng)审(shen)(shen)(shen)(shen)批的(de)(de)(de)中药(yao)(yao)(yao)、化学药(yao)(yao)(yao)、生物(wu)制品各(ge)类(lei)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)8787件(jian),较(jiao)2019年(nian)(nian)增(zeng)长(zhang)29.51%。其(qi)中,受理需审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批的(de)(de)(de)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)(临(lin)床(chuang)试验(yan)申(shen)(shen)请(qing)(qing)(qing)(qing)、一(yi)致(zhi)性评(ping)价申(shen)(shen)请(qing)(qing)(qing)(qing)、补(bu)充(chong)申(shen)(shen)请(qing)(qing)(qing)(qing)、境外生产药(yao)(yao)(yao)品再注(zhu)册(ce)及复审(shen)(shen)(shen)(shen))5695件(jian),较(jiao)2019年(nian)(nian)增(zeng)长(zhang)16.06%;受理直(zhi)接(jie)行(xing)(xing)政(zheng)审(shen)(shen)(shen)(shen)批的(de)(de)(de)注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)(无需技术(shu)审(shen)(shen)(shen)(shen)评(ping)的(de)(de)(de)补(bu)充(chong)申(shen)(shen)请(qing)(qing)(qing)(qing)、临(lin)时进口申(shen)(shen)请(qing)(qing)(qing)(qing))3092件(jian),较(jiao)2019年(nian)(nian)增(zeng)长(zhang)64.64%。2020年(nian)(nian)行(xing)(xing)政(zheng)审(shen)(shen)(shen)(shen)批注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)受理的(de)(de)(de)具体情况(kuang)详见(jian)表15。2016-2020年(nian)(nian)行(xing)(xing)政(zheng)审(shen)(shen)(shen)(shen)批注(zhu)册(ce)申(shen)(shen)请(qing)(qing)(qing)(qing)受理情况(kuang)详见(jian)图(tu)25。

 

(2)需审(shen)评审(shen)批的注册申(shen)请受理(li)情况

药(yao)审(shen)(shen)(shen)中心(xin)受理(li)5695件(jian)需(xu)审(shen)(shen)(shen)评审(shen)(shen)(shen)批的注册申请(qing)中,临床(chuang)试验申请(qing)1618件(jian)(含验证性临床(chuang))、一致(zhi)性评价申请(qing)914件(jian)、补(bu)充申请(qing)2827件(jian)、境外生产药(yao)品再注册328件(jian)、复审(shen)(shen)(shen)8件(jian)。

(3)直接行政审批的注册申请受理情况

药(yao)(yao)审中(zhong)心(xin)受(shou)理3092件(jian)直接(jie)行政审批(pi)的注册(ce)申(shen)(shen)请(qing)中(zhong),按(an)(an)申(shen)(shen)请(qing)类(lei)型划分,补(bu)充申(shen)(shen)请(qing)2644件(jian)、临时进口申(shen)(shen)请(qing)448件(jian)。按(an)(an)药(yao)(yao)品(pin)类(lei)型划分,中(zhong)药(yao)(yao)156件(jian)、化(hua)学药(yao)(yao)2499件(jian)、生物制(zhi)品(pin)437件(jian)。

 三、重点治疗(liao)领域品种

新冠(guan)病毒(du)疫苗(miao)和新冠(guan)肺(fei)炎(yan)治疗药物:

1.新(xin)(xin)型(xing)冠(guan)状(zhuang)(zhuang)病(bing)毒(du)灭活疫苗(miao)(Vero细胞),为国内(nei)首个(ge)附条件批准的新(xin)(xin)冠(guan)病(bing)毒(du)疫苗(miao),也(ye)是全(quan)球首个(ge)新(xin)(xin)冠(guan)病(bing)毒(du)灭活疫苗(miao)。适用于18岁及以上人群预防(fang)由新(xin)(xin)型(xing)冠(guan)状(zhuang)(zhuang)病(bing)毒(du)(SARS-CoV-2)感染引起(qi)的疾病(bing)。

2.“三药(yao)(yao)”品种,为《新(xin)型(xing)(xing)冠(guan)(guan)状(zhuang)病(bing)毒肺(fei)炎(yan)诊(zhen)疗方案(试行)》推荐药(yao)(yao)物(wu),即(ji)连花(hua)(hua)清(qing)瘟颗(ke)粒(li)(li)/胶囊、金花(hua)(hua)清(qing)感颗(ke)粒(li)(li)和血必(bi)净注射(she)液。连花(hua)(hua)清(qing)瘟颗(ke)粒(li)(li)/胶囊和金花(hua)(hua)清(qing)感颗(ke)粒(li)(li)新(xin)增(zeng)(zeng)适应(ying)症用(yong)于在(zai)新(xin)型(xing)(xing)冠(guan)(guan)状(zhuang)病(bing)毒肺(fei)炎(yan)的常规治疗中(zhong)的轻型(xing)(xing)、普通型(xing)(xing)引起的发热、咳嗽、乏(fa)力(li),血必(bi)净注射(she)液新(xin)增(zeng)(zeng)适应(ying)症用(yong)于新(xin)型(xing)(xing)冠(guan)(guan)状(zhuang)病(bing)毒肺(fei)炎(yan)重型(xing)(xing)、危重型(xing)(xing)的全身炎(yan)症反(fan)应(ying)综合征或(huo)/和多脏(zang)器(qi)功能衰竭,其获(huo)批上市充分发挥(hui)了中(zhong)医药(yao)(yao)在(zai)疫情(qing)防控中(zhong)的作用(yong)。

3.注射用(yong)西维来司他(ta)钠,为中性(xing)粒细胞弹性(xing)蛋白酶选(xuan)择性(xing)抑制(zhi)剂,适用(yong)于改善(shan)伴有全身性(xing)炎症反应综合征(zheng)的(de)(de)急(ji)(ji)性(xing)肺损伤/急(ji)(ji)性(xing)呼吸窘迫综合征(zheng)(ALI/ARDS),是全球(qiu)唯(wei)一用(yong)于ALI/ARDS的(de)(de)药物(wu)(wu),其(qi)获(huo)批(pi)上市(shi)填补了我国ALI/ARDS药物(wu)(wu)治疗领域的(de)(de)空白,为我国呼吸系(xi)统危重症患者提供用(yong)药选(xuan)择。

抗肿瘤药(yao)物(wu):

4.甲(jia)磺酸阿美替尼片(pian),为我国首个具有自主知识产(chan)权的(de)第三代靶(ba)向表皮生(sheng)长因子受体(EGFR)小(xiao)分子酪氨(an)酸激酶抑制剂(ji)(TKI)创新药物(wu),适用(yong)于治(zhi)(zhi)(zhi)疗(liao)既(ji)往经EGFR-TKI治(zhi)(zhi)(zhi)疗(liao)时(shi)或治(zhi)(zhi)(zhi)疗(liao)后出现(xian)疾病进展,并且经检测(ce)确认存在EGFR T790M突变(bian)阳性的(de)局部晚(wan)期或转(zhuan)移性非小(xiao)细胞肺(fei)癌。本(ben)品(pin)疗(liao)效(xiao)突出,脑转(zhuan)移病灶控制良好,其获(huo)批上市将(jiang)显著改善该疾病治(zhi)(zhi)(zhi)疗(liao)药物(wu)的(de)可(ke)及性。

5.索(suo)凡替(ti)尼胶囊,为多靶(ba)点、抗血管(guan)生成口服小(xiao)分子(zi)酪(lao)氨酸(suan)激酶(mei)抑制剂,是(shi)国内首个用于(yu)治(zhi)疗(liao)无法(fa)手术切除的(de)(de)局(ju)部晚期或转移性、进展期非功能性、分化良好(G1、G2)的(de)(de)非胰腺来(lai)源的(de)(de)神经内分泌瘤的(de)(de)创(chuang)新药物(wu)。本品疗(liao)效突出(chu),显著降(jiang)低了(le)此(ci)类患者的(de)(de)疾病进展和(he)死(si)亡风险(xian),其获批上市填补了(le)该疾病治(zhi)疗(liao)领域的(de)(de)空白。

6.注射(she)用(yong)维布妥昔单(dan)抗,为(wei)全球首(shou)个CD30靶点抗体(ti)偶联药(yao)物(ADC),也是(shi)国(guo)内首(shou)个用(yong)于(yu)恶性(xing)淋(lin)巴(ba)(ba)瘤患(huan)者的(de)(de)ADC药(yao)物,适用(yong)于(yu)治疗复发或难治性(xing)的(de)(de)系统性(xing)间(jian)变性(xing)大细胞(bao)淋(lin)巴(ba)(ba)瘤和(he)经典型霍奇金(jin)淋(lin)巴(ba)(ba)瘤,本(ben)品获批上市为(wei)改(gai)善我国(guo)此类(lei)患(huan)者的(de)(de)长(zhang)期生存提供了有(you)效的(de)(de)治疗手段(duan)。

7.注射用贝(bei)林(lin)妥欧单抗,为全球(qiu)首个双特异性(xing)抗体(CD3和CD19靶点)药物,也是(shi)我国(guo)首个用于(yu)肿瘤适应症(zheng)的(de)双特异性(xing)抗体药物,适用于(yu)治疗(liao)成人复发或难(nan)治性(xing)前(qian)体B细胞(bao)急(ji)性(xing)淋(lin)(lin)巴(ba)细胞(bao)白血病。对于(yu)化疗(liao)失败的(de)复发或难(nan)治性(xing)急(ji)性(xing)淋(lin)(lin)巴(ba)细胞(bao)白血病患(huan)(huan)者(zhe),与标准化疗(liao)相(xiang)比(bi),本(ben)品可显著延长(zhang)患(huan)(huan)者(zhe)生存期,其获(huo)批上市为我国(guo)此类患(huan)(huan)者(zhe)提供了更好的(de)治疗(liao)手段。

8.甲(jia)磺酸仑伐替尼胶囊(nang),为多靶点、口服(fu)酪氨(an)酸激酶抑制剂,是国(guo)(guo)内首个用于治疗进(jin)展性、局部晚期(qi)或转移性放射性碘(dian)难治性分(fen)化型(xing)甲(jia)状腺癌(ai)的小分(fen)子药物。本品疗效突出,其获批(pi)上市为我国(guo)(guo)此(ci)类(lei)患者提供了有效的治疗方案,填补了该(gai)治疗领(ling)域(yu)的空白(bai)。

抗(kang)感(gan)染药(yao)物(wu):

9.盐酸(suan)可(ke)洛派韦胶囊,为非结构蛋白5A(NS5A)抑(yi)制剂,是我(wo)国具有自主知识产权的(de)广谱(pu)、直接抗丙(bing)(bing)肝(gan)(gan)病(bing)毒创新(xin)药物,适用于(yu)与索磷(lin)布韦联用治(zhi)(zhi)疗初治(zhi)(zhi)或干(gan)扰素经(jing)治(zhi)(zhi)的(de)基因1、2、3、6型成人慢(man)性(xing)(xing)丙(bing)(bing)型肝(gan)(gan)炎病(bing)毒感(gan)染(ran),可(ke)合并(bing)或不合并(bing)代偿性(xing)(xing)肝(gan)(gan)硬化,本品(pin)获批(pi)上(shang)市为我(wo)国慢(man)性(xing)(xing)丙(bing)(bing)肝(gan)(gan)患者(zhe)提供了一种新(xin)的(de)治(zhi)(zhi)疗选择。

10.恩曲他滨替诺福韦片,增加适应(ying)症(zheng)用于(yu)(yu)降(jiang)低成(cheng)人和青少年(体(ti)重(zhong)至少在35 kg以(yi)上)通过高风险性行为获(huo)得HIV-1的(de)风险,是国内首个用于(yu)(yu)暴露前(qian)预防HIV的(de)药物。HIV感染是重(zhong)大(da)公共卫生问题,本品(pin)获(huo)批(pi)上市对于(yu)(yu)控制HIV传(chuan)播具(ju)有重(zhong)大(da)意(yi)义。

循环系统药物:

11.拉那利尤单抗注射液,为全(quan)人(ren)源化单克隆抗体(ti)(IgG1/K-轻链),是(shi)我国首个用于(yu)12岁及(ji)(ji)以(yi)上患者预防遗传性血(xue)管性水肿(HAE)发作(zuo)的药物(wu)。HAE疾病反复发作(zuo),近(jin)半数(shu)患者可出现上呼吸道(dao)黏膜水肿引(yin)发窒(zhi)息(xi)而危及(ji)(ji)生命,本品获(huo)批上市为我国HAE患者预防发作(zuo)提供了安全(quan)有效的治疗手(shou)段。

12.氯苯唑酸软(ruan)胶囊,为转甲状腺素(su)(su)蛋白(TTR)稳定剂,适用于治(zhi)疗(liao)转甲状腺素(su)(su)蛋白淀粉样变(bian)性(xing)心肌病,以减少(shao)心血(xue)(xue)管(guan)死亡(wang)及心血(xue)(xue)管(guan)相(xiang)关(guan)住院。该疾(ji)(ji)病是一种致(zhi)命性(xing)疾(ji)(ji)病,属罕(han)见(jian)病,本品为我(wo)国(guo)首个针对(dui)该病病因治(zhi)疗(liao)的药(yao)物,其(qi)获批上市为我(wo)国(guo)此类患(huan)者提(ti)供了新的治(zhi)疗(liao)手(shou)段。

呼吸系统药物(wu):

13.苯环喹溴铵鼻(bi)喷(pen)雾(wu)剂,为胆(dan)(dan)碱能受体拮(jie)抗剂,为我国首个具有自主(zhu)知识产权用于(yu)变(bian)应性鼻(bi)炎的(de)(de)鼻(bi)用抗胆(dan)(dan)碱创新药物,适(shi)用于(yu)改善变(bian)应性鼻(bi)炎引起的(de)(de)流(liu)涕、鼻(bi)塞、鼻(bi)痒和(he)喷(pen)嚏症状,本(ben)品其获批上市可为我国此类(lei)患者提供新的(de)(de)治疗选择(ze)。

14.乙磺酸尼达尼布软胶囊(nang),为小分子酪氨酸激酶抑制剂,具有(you)抗纤(xian)维(wei)(wei)化作用,增加适应(ying)(ying)症用于治(zhi)疗系统性(xing)硬(ying)化病相关间质性(xing)肺疾(ji)病(SSc-ILD)和具有(you)进行(xing)性(xing)表型(xing)的慢性(xing)纤(xian)维(wei)(wei)化性(xing)间质性(xing)肺疾(ji)病(PF-ILD)。目(mu)前可用于SSc-ILD和PF-ILD的有(you)效治(zhi)疗方式有(you)限,临床(chuang)用药需(xu)求迫切(qie),本品获批(pi)新增适应(ying)(ying)症可以填补该治(zhi)疗领域空白,为我国此类患者提(ti)供药物选择。

神经(jing)系统(tong)药物:

15.氘丁苯那嗪片(pian),为囊泡单胺转运蛋白2(VMAT2)抑制(zhi)剂,是我(wo)国(guo)(guo)首个用于治(zhi)疗与(yu)罕(han)见病亨廷(ting)顿病有关(guan)的舞蹈病、迟发性运动障碍(ai)的药(yao)物(wu),属临(lin)床(chuang)急需境(jing)外(wai)新(xin)药(yao)名单品种,本品获批(pi)上市(shi)满(man)足了我(wo)国(guo)(guo)此类患者迫切的临(lin)床(chuang)需求(qiu)。

16.氯苯唑酸葡胺(an)软胶囊,为转(zhuan)甲(jia)状腺(xian)素(su)蛋白(TTR)稳定(ding)剂,是我国(guo)首个用于治疗成人转(zhuan)甲(jia)状腺(xian)素(su)蛋白淀粉(fen)样变(bian)性(xing)(xing)多发(fa)性(xing)(xing)神经(jing)病(bing)I期症状患者、延缓周围(wei)神经(jing)功(gong)能损(sun)害的药(yao)物,属临床急需境(jing)外(wai)新药(yao)名单品种,其获批上市改变(bian)了(le)该病(bing)无药(yao)可治的局(ju)面(mian)。

镇痛药及麻醉科药物(wu):

17.环泊酚(fen)注射(she)液,为GABAA受体(ti)激动剂,是(shi)用于(yu)消化道内(nei)(nei)镜(jing)检(jian)查中(zhong)镇(zhen)静的创新(xin)药(yao)物(wu)。本(ben)品与临床常用麻(ma)醉镇(zhen)静药(yao)物(wu)丙泊酚(fen)具有相似的药(yao)理机制(zhi),但具有起效(xiao)快(kuai)(kuai),注射(she)痛少,呼吸(xi)抑制(zhi)轻,恢复速度快(kuai)(kuai)等优势特征,其获批上市可为我国消化内(nei)(nei)镜(jing)检(jian)查操作(zuo)用药(yao)提供新(xin)的选(xuan)择。

皮(pi)肤五官药物:

18.塞奈吉明滴眼(yan)液(ye),为(wei)(wei)国(guo)内(nei)首个用于(yu)治疗(liao)(liao)神经营养性角膜炎(NK)的(de)重组人神经生长(zhang)因子(rhNGF)药物,属临(lin)床急需境外新药名单品(pin)种。NK为(wei)(wei)罕见的(de)退行性角膜疾病(bing),可致盲,中(zhong)重度NK手(shou)术治疗(liao)(liao)为(wei)(wei)侵入性操作(zuo),费(fei)用高且(qie)不能永久治愈,本(ben)品(pin)获批(pi)上市(shi)为(wei)(wei)我(wo)国(guo)此类患者(zhe)提供了有效的(de)治疗(liao)(liao)药物,预计(ji)将成为(wei)(wei)中(zhong)重度NK患者(zhe)的(de)首选治疗(liao)(liao)。

19.度(du)(du)普利尤单(dan)抗注射液,为(wei)重组(zu)人免疫球(qiu)蛋白-G4单(dan)克隆(long)抗体,适用(yong)于治疗外用(yong)处(chu)方药(yao)控制不佳或不建议使用(yong)外用(yong)处(chu)方药(yao)的成(cheng)人中(zhong)重度(du)(du)特应(ying)性皮炎,属临(lin)床急需境(jing)外新(xin)药(yao)名单(dan)品种。与现(xian)有(you)(you)治疗方式相比,本品有(you)(you)明显临(lin)床优势(shi),其获批上市为(wei)此类难治性严(yan)重疾病患(huan)者提供(gong)了治疗选择。

消化系(xi)统药物:

20.注射用维得利珠单抗(kang),为作用于人淋(lin)巴细胞整合素α4β7的(de)人源化单克隆抗(kang)体,适用于治(zhi)(zhi)疗对传统治(zhi)(zhi)疗或(huo)肿瘤坏死因子α(TNF-α)抑制剂应(ying)答不(bu)充分、失(shi)应(ying)答或(huo)不(bu)耐(nai)受的(de)中度(du)至重度(du)活动性(xing)溃疡性(xing)结肠炎、克罗恩(en)病(bing),属临(lin)床(chuang)急需(xu)境外新药名单品种。此类疾病(bing)存在(zai)迫切的(de)临(lin)床(chuang)治(zhi)(zhi)疗需(xu)求,特别(bie)是(shi)对于TNF-α拮抗(kang)剂治(zhi)(zhi)疗失(shi)败的(de)患者,本品获批(pi)上市可为临(lin)床(chuang)提供(gong)新的(de)治(zhi)(zhi)疗选择。

外(wai)科药(yao)物:

21.注射用(yong)丹曲林(lin)钠(na),适(shi)用(yong)于预防及治疗(liao)恶性高热(re)(MH),是目(mu)前唯一短时间内(nei)给药可(ke)改变(bian)该疾(ji)病转(zhuan)归的(de)药物(wu)。MH临床(chuang)结局危重(zhong),死亡率(lv)高,其(qi)获批上市可(ke)改变(bian)目(mu)前国(guo)内(nei)MH无安(an)全有效治疗(liao)手段(duan)的(de)现状,满(man)足迫切(qie)临床(chuang)需求。

22.他克莫司颗粒,适用于预防儿(er)(er)(er)童(tong)肝(gan)(gan)脏(zang)或肾脏(zang)移(yi)(yi)植(zhi)术(shu)后的(de)移(yi)(yi)植(zhi)物排(pai)斥反应(ying),治疗(liao)儿(er)(er)(er)童(tong)肝(gan)(gan)脏(zang)或肾脏(zang)移(yi)(yi)植(zhi)术(shu)后应(ying)用其他免疫抑制(zhi)(zhi)药(yao)(yao)物无法控制(zhi)(zhi)的(de)移(yi)(yi)植(zhi)物排(pai)斥反应(ying),属儿(er)(er)(er)童(tong)用药(yao)(yao),本(ben)品获(huo)批(pi)上市可(ke)极大解决(jue)我国儿(er)(er)(er)科(ke)肝(gan)(gan)肾移(yi)(yi)植(zhi)患者未满足的(de)临床(chuang)需求。

罕见病(bing)药物:

23.注射用(yong)(yong)拉罗(luo)尼(ni)酶(mei)(mei)浓溶液,为国(guo)(guo)(guo)内(nei)首个用(yong)(yong)于罕见病(bing)黏多糖(tang)贮积(ji)(ji)症(zheng)I型(xing)(MPS I,α-L-艾杜糖(tang)苷(gan)酶(mei)(mei)缺乏症(zheng))的(de)酶(mei)(mei)替代治(zhi)疗药物,属临床急需境外新药名单品(pin)(pin)种。黏多糖(tang)贮积(ji)(ji)症(zheng)I型(xing)是一种严(yan)重(zhong)危及生命(ming)且国(guo)(guo)(guo)内(nei)尚无(wu)有效治(zhi)疗手段的(de)遗传性(xing)罕见病(bing),已(yi)列入我国(guo)(guo)(guo)第一批罕见病(bing)目录,本(ben)品(pin)(pin)获批上市填补了我国(guo)(guo)(guo)此类患者的(de)用(yong)(yong)药空白。

24.艾度硫(liu)酸(suan)酯酶(mei)β注(zhu)射液,为国(guo)内首个(ge)用于(yu)罕(han)见病黏多糖贮积症(zheng)Ⅱ型(MPS Ⅱ,亨特综合(he)征)的(de)(de)酶(mei)替代(dai)治疗药物(wu)。黏多糖贮积症(zheng)Ⅱ型是(shi)一(yi)种(zhong)严重危及生命且(qie)国(guo)内尚(shang)无有效治疗手(shou)段的(de)(de)遗(yi)传(chuan)性罕(han)见病,已列(lie)入我(wo)国(guo)第一(yi)批罕(han)见病目(mu)录,本品获批上市填补了我(wo)国(guo)此类患者的(de)(de)用药空白(bai)。

体内(nei)诊断试(shi)剂:

25.重组结(jie)核(he)杆(gan)菌融合蛋(dan)白(EC),适用(yong)(yong)于6月龄及以(yi)上(shang)婴(ying)儿、儿童及65周岁以(yi)下成人(ren)结(jie)核(he)杆(gan)菌感染诊断,并可用(yong)(yong)于辅(fu)助结(jie)核(he)病的临床(chuang)诊断,为全球首个用(yong)(yong)于鉴(jian)别(bie)卡介苗(miao)接种与结(jie)核(he)杆(gan)菌感染的体内(nei)诊断产品(pin),其获批上(shang)市为临床(chuang)鉴(jian)别(bie)诊断提供了新的手段。

预防用生物制品(疫苗):

26.鼻(bi)喷(pen)冻干流感减毒活疫苗:为国(guo)内首家以鼻(bi)喷(pen)途径接种的(de)(de)疫苗,适用于3(36月龄)~17岁(sui)人群(qun)用于预防由疫苗相关型(xing)别(bie)的(de)(de)流感病毒引起的(de)(de)流行性感冒,接种后可刺激机体产生抗流感病毒的(de)(de)免(mian)疫力。

中药新药:

27.桑(sang)枝(zhi)(zhi)总(zong)生物(wu)(wu)碱片,其主(zhu)要成分(fen)为桑(sang)枝(zhi)(zhi)中(zhong)提(ti)取得到的(de)桑(sang)枝(zhi)(zhi)总(zong)生物(wu)(wu)碱,是近10年(nian)来(lai)首个获批上(shang)市的(de)抗糖尿病(bing)中(zhong)药新药,适用于配合饮(yin)食(shi)控(kong)制及运动(dong)、治疗2型糖尿病(bing)。本品可有效降低2型糖尿病(bing)受试者(zhe)糖化(hua)血红蛋白水平,其获批上(shang)市为2型糖尿病(bing)患者(zhe)提(ti)供新的(de)治疗选择(ze)。

28.筋(jin)骨止痛凝胶,为(wei)醋延(yan)胡(hu)索(suo)、川芎等12种药味组成(cheng)(cheng)的(de)(de)中(zhong)药复方新药,适用于(yu)膝(xi)骨关(guan)节(jie)炎肾虚筋(jin)脉瘀(yu)滞证的(de)(de)症状改(gai)善,具(ju)有“活(huo)血理(li)气,祛风除湿,通络止痛”的(de)(de)功效(xiao)。本(ben)品为(wei)外(wai)用凝胶制剂,药物(wu)中(zhong)各成(cheng)(cheng)分通过透皮吸收而发挥作(zuo)用,可避(bi)免肠(chang)胃吸收和肝脏首过代谢(xie),其获(huo)批上市(shi)可为(wei)膝(xi)关(guan)节(jie)骨性(xing)关(guan)节(jie)炎患(huan)者提供新的(de)(de)治疗选择。

29.连花清咳片,为(wei)麻(ma)黄(huang)、桑白皮等15种药味组成的(de)中药新药,适用于治疗急性气管-支(zhi)气管炎痰(tan)热(re)壅肺证引起(qi)的(de)咳嗽、咳痰(tan)等,具有“宣肺泄(xie)热(re),化(hua)痰(tan)止咳”的(de)功效(xiao),其获批(pi)上市可(ke)为(wei)急性气管-支(zhi)气管炎患(huan)者提(ti)供(gong)新的(de)治疗选择。

四、全力做好应(ying)急审评工(gong)作

(一)加(jia)强(qiang)统一领(ling)导,制(zhi)定工作(zuo)程序

按(an)照(zhao)国(guo)家药(yao)监局(ju)党组关于疫情防控(kong)应急审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)工(gong)作(zuo)(zuo)(zuo)(zuo)部署,药(yao)审(shen)(shen)中心闻令(ling)而动,一是充分发挥集体决(jue)策作(zuo)(zuo)(zuo)(zuo)用(yong),迅速(su)成(cheng)立抗新(xin)(xin)型冠(guan)状(zhuang)(zhuang)病(bing)毒药(yao)物特(te)别(bie)审(shen)(shen)评(ping)(ping)领导小组,抽(chou)调16个部门148名骨干力量为(wei)工(gong)作(zuo)(zuo)(zuo)(zuo)小组成(cheng)员,先后召开(kai)特(te)别(bie)审(shen)(shen)评(ping)(ping)领导小组会(hui)(hui)议(yi)6次和领导小组专(zhuan)题会(hui)(hui)18次,明晰工(gong)作(zuo)(zuo)(zuo)(zuo)原则(ze),优(you)化工(gong)作(zuo)(zuo)(zuo)(zuo)流(liu)程(cheng)(cheng),及时研(yan)究解(jie)决(jue)应急审(shen)(shen)评(ping)(ping)过程(cheng)(cheng)中遇(yu)到的问题,保证(zheng)工(gong)作(zuo)(zuo)(zuo)(zuo)顺利(li)推进、有(you)序(xu)开(kai)展。二是制定工(gong)作(zuo)(zuo)(zuo)(zuo)程(cheng)(cheng)序(xu),形成(cheng)1个方案、2个程(cheng)(cheng)序(xu)、1个规范(fan)(fan),即《药(yao)审(shen)(shen)中心抗新(xin)(xin)型冠(guan)状(zhuang)(zhuang)病(bing)毒药(yao)物特(te)别(bie)审(shen)(shen)评(ping)(ping)工(gong)作(zuo)(zuo)(zuo)(zuo)方案》《关于新(xin)(xin)型冠(guan)状(zhuang)(zhuang)病(bing)毒(2019-nCoV)药(yao)物立项申请评(ping)(ping)议(yi)工(gong)作(zuo)(zuo)(zuo)(zuo)程(cheng)(cheng)序(xu)》《关于新(xin)(xin)型冠(guan)状(zhuang)(zhuang)病(bing)毒(2019-nCoV)药(yao)物特(te)别(bie)专(zhuan)家组评(ping)(ping)估和审(shen)(shen)核工(gong)作(zuo)(zuo)(zuo)(zuo)程(cheng)(cheng)序(xu)》《国(guo)家药(yao)监局(ju)抗新(xin)(xin)型冠(guan)状(zhuang)(zhuang)病(bing)毒药(yao)物专(zhuan)家会(hui)(hui)议(yi)管理规范(fan)(fan)》。三是严(yan)格(ge)落(luo)实(shi)“安全(quan)守底线、疗效有(you)证(zheng)据、质量能(neng)保证(zheng)、审(shen)(shen)评(ping)(ping)超常(chang)规”的工(gong)作(zuo)(zuo)(zuo)(zuo)要求,按(an)照(zhao)工(gong)作(zuo)(zuo)(zuo)(zuo)程(cheng)(cheng)序(xu),依法依规、科(ke)学规范(fan)(fan)审(shen)(shen)评(ping)(ping),标(biao)准不降,加(jia)速(su)审(shen)(shen)批(pi)。

(二(er))发挥(hui)专家(jia)作(zuo)用,解(jie)决技(ji)术难(nan)题

一(yi)是组(zu)(zu)建特(te)别(bie)专(zhuan)(zhuan)家(jia)(jia)组(zu)(zu)。按照《国(guo)(guo)家(jia)(jia)食品(pin)(pin)药品(pin)(pin)监(jian)(jian)(jian)督管(guan)理(li)局药品(pin)(pin)特(te)别(bie)审(shen)批程(cheng)序》(原国(guo)(guo)家(jia)(jia)食品(pin)(pin)药品(pin)(pin)监(jian)(jian)(jian)督管(guan)理(li)局令第21号)规定(ding)和(he)国(guo)(guo)家(jia)(jia)药监(jian)(jian)(jian)局新型冠(guan)状病(bing)毒(du)感(gan)染肺炎(yan)疫情(qing)应对(dui)工(gong)作组(zu)(zu)药品(pin)(pin)组(zu)(zu)的(de)(de)决(jue)(jue)定(ding),药审(shen)中心先后遴选出多位院士(shi)和(he)知名专(zhuan)(zhuan)家(jia)(jia)组(zu)(zu)成了特(te)别(bie)专(zhuan)(zhuan)家(jia)(jia)组(zu)(zu),经国(guo)(guo)家(jia)(jia)药监(jian)(jian)(jian)局批准后开展工(gong)作。遇到(dao)新的(de)(de)技术难点问题时,听取专(zhuan)(zhuan)家(jia)(jia)意见建议(yi)后,由(you)专(zhuan)(zhuan)家(jia)(jia)投票(piao)表决(jue)(jue)。二是注重发挥专(zhuan)(zhuan)家(jia)(jia)技术支撑作用(yong)。通过专(zhuan)(zhuan)家(jia)(jia)研讨会和(he)专(zhuan)(zhuan)家(jia)(jia)咨询会解决(jue)(jue)特(te)定(ding)技术问题,例如针对(dui)mRNA新冠(guan)病(bing)毒(du)疫苗在(zai)(zai)研发上存(cun)在(zai)(zai)的(de)(de)难点和(he)潜在(zai)(zai)的(de)(de)风险,药审(shen)中心组(zu)(zu)织专(zhuan)(zhuan)家(jia)(jia)形(xing)成技术指导原则,以(yi)指导相关企业(ye)的(de)(de)研发。

(三)实时高效沟通,提高研(yan)发进度

一是遵循“早期介入、持续跟(gen)进、主动服务”的工(gong)作要求(qiu),第一时间组(zu)织审(shen)评(ping)力(li)量对咨询品种或(huo)注(zhu)册申(shen)请(qing)立项的科学性和可行(xing)性进行(xing)评(ping)议,并(bing)在(zai)24小时内(nei)与(yu)申(shen)请(qing)人进行(xing)沟通交(jiao)流,保证申(shen)请(qing)人尽(jin)快(kuai)提(ti)交(jiao)特别审(shen)批注(zhu)册申(shen)请(qing)。二是加(jia)强国际合作。积极(ji)参加(jia)世界卫生组(zu)织(WHO)、国际药品监管(guan)机构联(lian)盟(ICMRA)等组(zu)织召开的视(shi)频电话会(hui)议,共同探讨(tao)研发审(shen)评(ping)标准,了解新冠病(bing)毒(du)疫苗研发信息,指(zhi)导推动研发企业(ye)赴国外开展Ⅲ期临床试验。

(四)探索(suo)研审联动,坚(jian)持科(ke)学审评

一是探索建立研(yan)(yan)(yan)(yan)(yan)发(fa)审评联动(dong)工(gong)作机制(zhi)(zhi)。边(bian)研(yan)(yan)(yan)(yan)(yan)发(fa)、边(bian)提交、边(bian)审评,为新冠(guan)(guan)病(bing)(bing)(bing)毒疫苗(miao)研(yan)(yan)(yan)(yan)(yan)发(fa)争取到了(le)宝贵时间(jian),确保新冠(guan)(guan)病(bing)(bing)(bing)毒疫苗(miao)等研(yan)(yan)(yan)(yan)(yan)发(fa)走在世界前列。通过这种工(gong)作机制(zhi)(zhi),大大缩短了(le)审评时间(jian)。二是建立技术(shu)标准(zhun)体系。针对新冠(guan)(guan)病(bing)(bing)(bing)毒的(de)特(te)点(dian),及时制(zhi)(zhi)定新冠(guan)(guan)病(bing)(bing)(bing)毒疫苗(miao)、新冠(guan)(guan)肺炎(yan)治疗(liao)药物研(yan)(yan)(yan)(yan)(yan)发(fa)技术(shu)指导原则等28个(ge)技术(shu)文件(jian),指导企业高标准(zhun)研(yan)(yan)(yan)(yan)(yan)发(fa),少走弯路,科学开展审评。

 五、鼓励中药传承创新发展(zhan)

贯彻落实(shi)(shi)习近(jin)平总书记关(guan)于(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)重(zhong)要(yao)指(zhi)(zhi)(zhi)(zhi)示精神(shen)(shen)、《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)共中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)央 国务院关(guan)于(yu)促(cu)(cu)进(jin)(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)传(chuan)(chuan)承创新(xin)(xin)(xin)(xin)(xin)发展(zhan)的(de)意(yi)见》及国家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监局要(yao)求(qiu),药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)审(shen)(shen)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)心从改革中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)(ce)分(fen)类(lei)、健(jian)全(quan)(quan)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)等各(ge)方(fang)(fang)面积极鼓励中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)守正创新(xin)(xin)(xin)(xin)(xin)。一是(shi)(shi)推动中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)传(chuan)(chuan)承发展(zhan)。起草并由国家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监局发布《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)(ce)分(fen)类(lei)及申(shen)报(bao)资(zi)料(liao)(liao)要(yao)求(qiu)》,丰富古代经(jing)典(dian)名方(fang)(fang)复方(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)的(de)范围,促(cu)(cu)进(jin)(jin)古代经(jing)典(dian)名方(fang)(fang)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)研(yan)(yan)(yan)发,推动其向新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)转化。二(er)是(shi)(shi)建立完(wan)善符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)点(dian)的(de)质(zhi)(zhi)(zhi)量(liang)控制(zhi)(zhi)(zhi)体系。遵循中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)点(dian)和(he)研(yan)(yan)(yan)发规律,将中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)独特(te)(te)的(de)理(li)论体系和(he)实(shi)(shi)践特(te)(te)点(dian)、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)剂(ji)质(zhi)(zhi)(zhi)量(liang)控制(zhi)(zhi)(zhi)特(te)(te)点(dian)与药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品质(zhi)(zhi)(zhi)量(liang)控制(zhi)(zhi)(zhi)的(de)一般要(yao)求(qiu)有机结合(he),研(yan)(yan)(yan)究(jiu)构(gou)建完(wan)善符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)剂(ji)特(te)(te)点(dian)的(de)质(zhi)(zhi)(zhi)量(liang)控制(zhi)(zhi)(zhi)方(fang)(fang)法(fa)和(he)策略,制(zhi)(zhi)(zhi)定《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)饮片炮(pao)制(zhi)(zhi)(zhi)研(yan)(yan)(yan)究(jiu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)(试(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)(zhi)量(liang)标(biao)准(zhun)研(yan)(yan)(yan)究(jiu)技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)(试(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)生产工(gong)艺研(yan)(yan)(yan)究(jiu)技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)(试(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)生物(wu)效(xiao)应(ying)检测研(yan)(yan)(yan)究(jiu)技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)(试(shi)行(xing))》等8个技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)。三是(shi)(shi)健(jian)全(quan)(quan)符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)点(dian)的(de)审(shen)(shen)评(ping)(ping)(ping)体系。引入新(xin)(xin)(xin)(xin)(xin)工(gong)具、新(xin)(xin)(xin)(xin)(xin)方(fang)(fang)法(fa)、新(xin)(xin)(xin)(xin)(xin)标(biao)准(zhun)用(yong)(yong)(yong)于(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)疗效(xiao)评(ping)(ping)(ping)价(jia),细化申(shen)报(bao)资(zi)料(liao)(liao)要(yao)求(qiu),制(zhi)(zhi)(zhi)定《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)于(yu)慢性(xing)便秘临床(chuang)研(yan)(yan)(yan)究(jiu)技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)于(yu)糖尿病(bing)肾病(bing)临床(chuang)研(yan)(yan)(yan)究(jiu)技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)》等技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze),探索构(gou)建中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)理(li)论、人用(yong)(yong)(yong)经(jing)验(yan)和(he)临床(chuang)试(shi)验(yan)相结合(he)的(de)审(shen)(shen)评(ping)(ping)(ping)证据体系。四是(shi)(shi)全(quan)(quan)力做好中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)别审(shen)(shen)评(ping)(ping)(ping)工(gong)作。充分(fen)发扬抗疫精神(shen)(shen),制(zhi)(zhi)(zhi)定了《用(yong)(yong)(yong)于(yu)新(xin)(xin)(xin)(xin)(xin)冠肺(fei)炎中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)(ce)申(shen)请(qing)特(te)(te)别审(shen)(shen)批申(shen)报(bao)资(zi)料(liao)(liao)要(yao)求(qiu)(试(shi)行(xing))》《用(yong)(yong)(yong)于(yu)新(xin)(xin)(xin)(xin)(xin)冠肺(fei)炎中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)(ce)申(shen)请(qing)特(te)(te)别审(shen)(shen)批技(ji)(ji)术(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)则(ze)(试(shi)行(xing))》等,指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)应(ying)急(ji)状态(tai)下的(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)审(shen)(shen)评(ping)(ping)(ping)。截至(zhi)2020年12月31日,“三方(fang)(fang)”中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)的(de)清(qing)肺(fei)排毒颗(ke)粒、化湿(shi)败毒颗(ke)粒的(de)IND申(shen)请(qing)已获批准(zhun),“三药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)”连(lian)花清(qing)瘟颗(ke)粒/胶(jiao)囊、金花清(qing)感颗(ke)粒、血必净注(zhu)射液获批增(zeng)加用(yong)(yong)(yong)于(yu)治(zhi)疗新(xin)(xin)(xin)(xin)(xin)冠肺(fei)炎的(de)适应(ying)症。五(wu)是(shi)(shi)赴武汉开(kai)展(zhan)实(shi)(shi)地(di)(di)调(diao)研(yan)(yan)(yan)和(he)座谈(tan),持续推进(jin)(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监管(guan)科学“以临床(chuang)价(jia)值为导(dao)(dao)(dao)向的(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)安全(quan)(quan)性(xing)评(ping)(ping)(ping)价(jia)研(yan)(yan)(yan)究(jiu)”课(ke)题研(yan)(yan)(yan)究(jiu)。六是(shi)(shi)开(kai)展(zhan)援疆援藏工(gong)作,赴西藏开(kai)展(zhan)实(shi)(shi)地(di)(di)调(diao)研(yan)(yan)(yan)、与新(xin)(xin)(xin)(xin)(xin)疆维(wei)吾(wu)尔自治(zhi)区药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品监督管(guan)理(li)局召开(kai)线上座谈(tan)交流会,支持民族药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)发展(zhan)。

  六、加强《药品注册管(guan)理办法(fa)》配(pei)套文件制修订(ding)

新(xin)修(xiu)订的(de)(de)(de)《药(yao)(yao)品(pin)注(zhu)册(ce)管理(li)(li)办(ban)(ban)法(fa)(fa)》是贯彻党中央、国务院审评审批制度改革精神(shen)和落(luo)实(shi)新(xin)修(xiu)订《药(yao)(yao)品(pin)管理(li)(li)法(fa)(fa)》的(de)(de)(de)重(zhong)要(yao)(yao)(yao)规(gui)章(zhang),考虑到(dao)药(yao)(yao)品(pin)注(zhu)册(ce)管理(li)(li)中的(de)(de)(de)具体(ti)技(ji)术(shu)(shu)要(yao)(yao)(yao)求,需(xu)要(yao)(yao)(yao)跟(gen)随技(ji)术(shu)(shu)发展的(de)(de)(de)脚(jiao)步不(bu)断调整完善,在规(gui)章(zhang)中不(bu)适宜(yi)作出具体(ti)的(de)(de)(de)规(gui)定,因此这些(xie)具体(ti)技(ji)术(shu)(shu)要(yao)(yao)(yao)求在《药(yao)(yao)品(pin)注(zhu)册(ce)管理(li)(li)办(ban)(ban)法(fa)(fa)》发布后,以配(pei)套文件、技(ji)术(shu)(shu)指导原(yuan)则等(deng)形式发布,既能(neng)更好地(di)顺应药(yao)(yao)品(pin)研发的(de)(de)(de)科学规(gui)律,也能(neng)确保新(xin)旧《药(yao)(yao)品(pin)注(zhu)册(ce)管理(li)(li)办(ban)(ban)法(fa)(fa)》的(de)(de)(de)平稳(wen)过渡和新(xin)《药(yao)(yao)品(pin)注(zhu)册(ce)管理(li)(li)办(ban)(ban)法(fa)(fa)》的(de)(de)(de)顺利实(shi)施。

根据国(guo)家局(ju)部(bu)署,药审中心(xin)统筹协调,加(jia)大配(pei)套(tao)(tao)文(wen)(wen)件的制(zhi)修(xiu)订力度,成立课(ke)题组,对重点(dian)难点(dian)问题开展(zhan)调研攻关(guan)(guan),充分(fen)听取专家、业界(jie)意见,力求(qiu)(qiu)达成共(gong)识,共(gong)参与了48个(ge)配(pei)套(tao)(tao)文(wen)(wen)件制(zhi)修(xiu)订工(gong)作,其中牵(qian)头(tou)起草(cao)配(pei)套(tao)(tao)文(wen)(wen)件30个(ge)。自开展(zhan)工(gong)作以来,已基本(ben)完成配(pei)套(tao)(tao)文(wen)(wen)件公开征求(qiu)(qiu)意见工(gong)作,部(bu)分(fen)文(wen)(wen)件已经(jing)国(guo)家局(ju)审核同意后发布实施,有效确保了各项审评任(ren)务不断、不散、不乱,新(xin)旧注册相关(guan)(guan)规定的顺利过渡和实施。

 七、加快审评技术标准体系建设

在药(yao)品审(shen)评和(he)(he)研(yan)发过程(cheng)中(zhong),指导原(yuan)则(ze)兼(jian)具监管依据和(he)(he)技(ji)术要求的双重职能。《药(yao)品注(zhu)册管理办法》明确从(cong)事(shi)药(yao)物(wu)研(yan)制(zhi)和(he)(he)药(yao)品注(zhu)册活动,应当(dang)遵守(shou)有关法律、法规、规章、标准和(he)(he)规范;药(yao)审(shen)中(zhong)心等专业技(ji)术机构,应当(dang)根据科学进展(zhan)、行业发展(zhan)实(shi)际和(he)(he)药(yao)品监督管理工作需要制(zhi)定技(ji)术指导原(yuan)则(ze)和(he)(he)程(cheng)序(xu),并向社会公布。

药(yao)(yao)品技(ji)术指(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)体系(xi)的(de)(de)建(jian)立与完善,是(shi)落实“四个最(zui)严”要求的(de)(de)最(zui)好实践,是(shi)药(yao)(yao)审(shen)(shen)中(zhong)(zhong)心(xin)推进(jin)审(shen)(shen)评(ping)体系(xi)和审(shen)(shen)评(ping)能(neng)力现代化的(de)(de)重要举措。药(yao)(yao)审(shen)(shen)中(zhong)(zhong)心(xin)通(tong)(tong)过(guo)“定标准、定程(cheng)序、定计划”三步走(zou)的(de)(de)方(fang)式,统(tong)筹(chou)规(gui)划以指(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)为核心(xin)的(de)(de)审(shen)(shen)评(ping)标准体系(xi)建(jian)设,围绕药(yao)(yao)品研发需求和鼓励(li)创新的(de)(de)原(yuan)(yuan)(yuan)则(ze),对标国际先进(jin)监(jian)管(guan)(guan)机构技(ji)术标准,加(jia)大指(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)制(zhi)定和公(gong)开力度。2020年(nian)共(gong)开展(zhan)了(le)119个技(ji)术指(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)制(zhi)修订工作,根(gen)据(ju)《国家药(yao)(yao)监(jian)局综合司关于(yu)印发药(yao)(yao)品技(ji)术指(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)发布程(cheng)序的(de)(de)通(tong)(tong)知》(药(yao)(yao)监(jian)综药(yao)(yao)管(guan)(guan)〔2020〕9号)要求,截(jie)至2020年(nian)12月31日,药(yao)(yao)审(shen)(shen)中(zhong)(zhong)心(xin)已(yi)经国家药(yao)(yao)监(jian)局审(shen)(shen)查(cha)同意(yi)发布了(le)71个指(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze),详见附件6。

在应(ying)对新(xin)型冠(guan)状(zhuang)病(bing)(bing)毒肺炎、促进新(xin)冠(guan)病(bing)(bing)毒疫苗(miao)和新(xin)冠(guan)肺炎治疗药(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)的(de)(de)研(yan)(yan)发(fa)(fa)(fa)和审(shen)评(ping)(ping)(ping)(ping)(ping)(ping)质量(liang)(liang)、速度方(fang)面(mian),药(yao)(yao)(yao)(yao)(yao)(yao)审(shen)中(zhong)(zhong)(zhong)心发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《新(xin)型冠(guan)状(zhuang)病(bing)(bing)毒预防用(yong)疫苗(miao)研(yan)(yan)发(fa)(fa)(fa)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)(试(shi)行(xing)(xing))》等(deng)7个指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze);在着(zhe)力提升中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)材质量(liang)(liang)研(yan)(yan)究,鼓励中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)研(yan)(yan)发(fa)(fa)(fa)与(yu)创(chuang)新(xin)方(fang)面(mian),发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)(yao)用(yong)药(yao)(yao)(yao)(yao)(yao)(yao)材质量(liang)(liang)控制研(yan)(yan)究技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)(试(shi)行(xing)(xing))》《中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)复(fu)方(fang)制剂(ji)生(sheng)(sheng)产工艺研(yan)(yan)究技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)(试(shi)行(xing)(xing))》《中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)(yao)用(yong)于慢(man)性便秘临(lin)床研(yan)(yan)究技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)》等(deng)10个指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze);在鼓励儿(er)童药(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa)方(fang)面(mian),发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《真实世界(jie)研(yan)(yan)究支(zhi)持儿(er)童药(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa)与(yu)审(shen)评(ping)(ping)(ping)(ping)(ping)(ping)的(de)(de)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)(试(shi)行(xing)(xing))》等(deng)3个指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze);在支(zhi)持抗(kang)(kang)肿(zhong)瘤(liu)(liu)药(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa),进一步满足申请人对具(ju)体抗(kang)(kang)肿(zhong)瘤(liu)(liu)药(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)的(de)(de)个药(yao)(yao)(yao)(yao)(yao)(yao)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)需(xu)求(qiu)方(fang)面(mian),发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《抗(kang)(kang)肿(zhong)瘤(liu)(liu)药(yao)(yao)(yao)(yao)(yao)(yao)联(lian)合(he)治疗临(lin)床试(shi)验(yan)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)》《注射(she)用(yong)曲(qu)妥珠(zhu)单抗(kang)(kang)生(sheng)(sheng)物(wu)(wu)(wu)类似药(yao)(yao)(yao)(yao)(yao)(yao)临(lin)床试(shi)验(yan)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)》等(deng)22个指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze);在提高仿(fang)制药(yao)(yao)(yao)(yao)(yao)(yao)质量(liang)(liang),推进仿(fang)制药(yao)(yao)(yao)(yao)(yao)(yao)一致性评(ping)(ping)(ping)(ping)(ping)(ping)价(jia)方(fang)面(mian),规范审(shen)评(ping)(ping)(ping)(ping)(ping)(ping)标准(zhun)和尺度,发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《化学药(yao)(yao)(yao)(yao)(yao)(yao)品注射(she)剂(ji)仿(fang)制药(yao)(yao)(yao)(yao)(yao)(yao)质量(liang)(liang)和疗效(xiao)一致性评(ping)(ping)(ping)(ping)(ping)(ping)价(jia)技(ji)术(shu)(shu)要求(qiu)》《化学药(yao)(yao)(yao)(yao)(yao)(yao)品注射(she)剂(ji)(特殊(shu)注射(she)剂(ji))仿(fang)制药(yao)(yao)(yao)(yao)(yao)(yao)质量(liang)(liang)和疗效(xiao)一致性评(ping)(ping)(ping)(ping)(ping)(ping)价(jia)技(ji)术(shu)(shu)要求(qiu)》等(deng)9个指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)。这些指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)覆(fu)盖(gai)新(xin)冠(guan)应(ying)急审(shen)评(ping)(ping)(ping)(ping)(ping)(ping)标准(zhun)、儿(er)童用(yong)药(yao)(yao)(yao)(yao)(yao)(yao)、中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)民族药(yao)(yao)(yao)(yao)(yao)(yao)技(ji)术(shu)(shu)标准(zhun)体系、抗(kang)(kang)肿(zhong)瘤(liu)(liu)药(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa)及仿(fang)制药(yao)(yao)(yao)(yao)(yao)(yao)研(yan)(yan)发(fa)(fa)(fa)等(deng)热点难点问题,持续完善(shan)药(yao)(yao)(yao)(yao)(yao)(yao)品技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)(yuan)(yuan)(yuan)则(ze)体系,有效(xiao)推动药(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa)创(chuang)新(xin),不断优(you)化统一审(shen)评(ping)(ping)(ping)(ping)(ping)(ping)尺度,大力提升审(shen)评(ping)(ping)(ping)(ping)(ping)(ping)质量(liang)(liang)和效(xiao)率,显著减少审(shen)评(ping)(ping)(ping)(ping)(ping)(ping)自(zi)由裁量(liang)(liang)权。

 八(ba)、持续(xu)深化药品审评审批制度改(gai)革

(一)加快(kuai)境外(wai)已上市临床急需新(xin)药审评(ping)

深入贯彻国(guo)务(wu)院常务(wu)会议(yi)精神,落(luo)实加快境(jing)(jing)外已(yi)上市(shi)临(lin)床急(ji)需(xu)(xu)新药审评要求,在(zai)确定了(le)(le)第(di)一二批(pi)(pi)(pi)74个品(pin)种(zhong)名单(dan)的(de)基(ji)础(chu)上,国(guo)家药监局(ju)、国(guo)家卫生健康委(wei)组织(zhi)有关(guan)专家研究论(lun)证(zheng),遴选临(lin)床急(ji)需(xu)(xu)新药品(pin)种(zhong),药审中心发(fa)布了(le)(le)第(di)三批(pi)(pi)(pi)7个品(pin)种(zhong)名单(dan)。对(dui)于(yu)符合《国(guo)家药品(pin)监督管理局(ju) 国(guo)家卫生健康委(wei)员会关(guan)于(yu)临(lin)床急(ji)需(xu)(xu)境(jing)(jing)外新药审评审批(pi)(pi)(pi)相(xiang)关(guan)事宜的(de)公(gong)告》(2018年第(di)79号)规定情形(xing)的(de)品(pin)种(zhong),国(guo)家药监局(ju)会同(tong)国(guo)家卫生健康委(wei)已(yi)组织(zhi)进行(xing)了(le)(le)充分遴选,基(ji)本解决了(le)(le)临(lin)床急(ji)需(xu)(xu)境(jing)(jing)外已(yi)上市(shi)新药在(zai)我国(guo)上市(shi)速度较(jiao)慢(man)的(de)问(wen)题,进一步提高了(le)(le)公(gong)众用(yong)药的(de)可(ke)及(ji)性(xing)。

2020年(nian),药(yao)审中心完成(cheng)了(le)13个(ge)用(yong)于治疗罕见(jian)(jian)病的(de)、临(lin)(lin)床急(ji)需(xu)(xu)的(de)药(yao)品(pin)的(de)技术审评(ping),均在规定时限内(nei)完成(cheng),罕见(jian)(jian)病药(yao)品(pin)在3个(ge)月之内(nei)完成(cheng)审评(ping),其(qi)他临(lin)(lin)床急(ji)需(xu)(xu)药(yao)品(pin)在6个(ge)月之内(nei)完成(cheng)审评(ping),大大缩短了(le)临(lin)(lin)床急(ji)需(xu)(xu)境外新药(yao)在我(wo)国上市(shi)的(de)时间差(cha)距。截至2020年(nian)12月31日,已(yi)(yi)发布的(de)三批(pi)81个(ge)品(pin)种(zhong)(zhong)临(lin)(lin)床急(ji)需(xu)(xu)境外已(yi)(yi)上市(shi)新药(yao)中,已(yi)(yi)有38家企业(ye)的(de)48个(ge)品(pin)种(zhong)(zhong)提出(chu)注册(ce)申请,其(qi)中39个(ge)品(pin)种(zhong)(zhong)已(yi)(yi)获批(pi)上市(shi)或完成(cheng)审评(ping),100%在时限内(nei)完成(cheng)审评(ping)工作,详见(jian)(jian)附件7。

(二)加速推动仿(fang)制药(yao)一致性评价(jia)工(gong)作

2020年,药(yao)审中(zhong)心采(cai)取切实(shi)有(you)效措施加速(su)推进(jin)仿制(zhi)药(yao)一致性评价工作。

一(yi)是在口(kou)服固体(ti)制(zhi)(zhi)剂(ji)(ji)(ji)一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)工(gong)作的基础上,积极(ji)推进注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji)一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)工(gong)作。国家(jia)药(yao)(yao)(yao)(yao)监局于5月12日发布《关于开展(zhan)化学药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji)仿制(zhi)(zhi)药(yao)(yao)(yao)(yao)质(zhi)量(liang)和(he)疗(liao)(liao)效一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)工(gong)作的公(gong)告》(2020年(nian)第(di)62号),正式启(qi)动注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji)一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)工(gong)作。药(yao)(yao)(yao)(yao)审(shen)(shen)中(zhong)心发布《化学药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji)仿制(zhi)(zhi)药(yao)(yao)(yao)(yao)质(zhi)量(liang)和(he)疗(liao)(liao)效一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)技(ji)术(shu)要(yao)求》《化学药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji)仿制(zhi)(zhi)药(yao)(yao)(yao)(yao)质(zhi)量(liang)和(he)疗(liao)(liao)效一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)申(shen)报(bao)资料要(yao)求》和(he)《化学药(yao)(yao)(yao)(yao)品(pin)(pin)注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji)(特殊注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji))仿制(zhi)(zhi)药(yao)(yao)(yao)(yao)质(zhi)量(liang)和(he)疗(liao)(liao)效一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)技(ji)术(shu)要(yao)求》等(deng)技(ji)术(shu)要(yao)求。针对(dui)正式启(qi)动前已有620件待审(shen)(shen)评(ping)(ping)(ping)(ping)的注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji)一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)申(shen)请,药(yao)(yao)(yao)(yao)审(shen)(shen)中(zhong)心成立专(zhuan)项审(shen)(shen)评(ping)(ping)(ping)(ping)工(gong)作组,采取细(xi)化分类处理措施,严格执行一(yi)次性(xing)(xing)(xing)(xing)(xing)发补,明(ming)确(que)注(zhu)(zhu)(zhu)射(she)(she)(she)剂(ji)(ji)(ji)一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)注(zhu)(zhu)(zhu)册检(jian)查(cha)的随机原则,加快审(shen)(shen)评(ping)(ping)(ping)(ping)速度,在不(bu)到5个月的时(shi)(shi)间(jian)内完(wan)成了620件品(pin)(pin)种(zhong)的审(shen)(shen)评(ping)(ping)(ping)(ping),一(yi)致(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)按时(shi)(shi)限审(shen)(shen)评(ping)(ping)(ping)(ping)已进入常(chang)态化。

二(er)是继(ji)续规(gui)范参(can)比(bi)(bi)制(zhi)(zhi)剂(ji)(ji)(ji)遴选(xuan)工(gong)作(zuo),强化服务与指导。药审(shen)中(zhong)心发(fa)布《化学仿制(zhi)(zhi)药参(can)比(bi)(bi)制(zhi)(zhi)剂(ji)(ji)(ji)遴选(xuan)申请(qing)(qing)资(zi)料要求》(药审(shen)中(zhong)心通告(gao)2020年(nian)第32号),进(jin)一(yi)(yi)步强调申请(qing)(qing)人的自(zi)查(cha)环节(jie),提高参(can)比(bi)(bi)制(zhi)(zhi)剂(ji)(ji)(ji)遴选(xuan)工(gong)作(zuo)效率。通过进(jin)一(yi)(yi)步规(gui)范内部审(shen)核、专家委员(yuan)会审(shen)核等流程(cheng),2020年(nian)优化了(le)参(can)比(bi)(bi)制(zhi)(zhi)剂(ji)(ji)(ji)遴选(xuan)工(gong)作(zuo)。自(zi)2017年(nian)8月开(kai)展一(yi)(yi)致(zhi)性评(ping)价工(gong)作(zuo)以来共发(fa)布参(can)比(bi)(bi)制(zhi)(zhi)剂(ji)(ji)(ji)目录35批,涉及3963个品(pin)规(gui)(1703个品(pin)种),其(qi)中(zhong)包(bao)括注射剂(ji)(ji)(ji)参(can)比(bi)(bi)制(zhi)(zhi)剂(ji)(ji)(ji)975个品(pin)规(gui)(405个品(pin)种)。

三是加(jia)强信息公开和(he)培训。2020年7月举办线上化学仿制药注(zhu)(zhu)射剂(ji)一致(zhi)性(xing)评价技术(shu)(shu)研讨会,对注(zhu)(zhu)射剂(ji)一致(zhi)性(xing)评价技术(shu)(shu)要(yao)求(qiu)、特殊注(zhu)(zhu)射剂(ji)技术(shu)(shu)要(yao)求(qiu)、参比(bi)制剂(ji)申请(qing)资(zi)料要(yao)求(qiu)等进行(xing)宣讲。

四是(shi)持(chi)续推进生(sheng)物(wu)等效性(xing)(xing)试验备案(an)工作。2020年化(hua)学(xue)药生(sheng)物(wu)等效性(xing)(xing)试验备案(an)平台共(gong)收集了(le)672条记(ji)录(lu),仿制药一致性(xing)(xing)评价生(sheng)物(wu)等效性(xing)(xing)试验备案(an)平台共(gong)收集了(le)292条记(ji)录(lu)。

(三)全面(mian)落实临床试(shi)验期间风险管理

为(wei)(wei)落实《药(yao)品(pin)管(guan)(guan)理法》《药(yao)品(pin)注(zhu)册管(guan)(guan)理办法》中有关临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)验(yan)期(qi)间安(an)全(quan)风险(xian)(xian)管(guan)(guan)理工作(zuo),药(yao)审中心(xin)在国家药(yao)监局指导下,发(fa)(fa)布了(le)《药(yao)物临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)验(yan)期(qi)间安(an)全(quan)信(xin)息(xi)评(ping)(ping)(ping)估(gu)与管(guan)(guan)理规范(fan)(试(shi)(shi)(shi)行)》、《研发(fa)(fa)期(qi)间安(an)全(quan)性(xing)更新(xin)(xin)报(bao)告管(guan)(guan)理规范(fan)(试(shi)(shi)(shi)行)》和《药(yao)物临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)验(yan)登记及信(xin)息(xi)公(gong)示(shi)管(guan)(guan)理规范(fan)(试(shi)(shi)(shi)行)》3个配套文件(jian)。为(wei)(wei)进(jin)一步加强临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)验(yan)过程的安(an)全(quan)信(xin)息(xi)监测(ce)、识别、评(ping)(ping)(ping)估(gu)和风险(xian)(xian)控制(zhi),制(zhi)定了(le)《药(yao)品(pin)审评(ping)(ping)(ping)中心(xin)药(yao)物临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)验(yan)期(qi)间安(an)全(quan)信(xin)息(xi)评(ping)(ping)(ping)估(gu)与风险(xian)(xian)管(guan)(guan)理工作(zuo)程序(试(shi)(shi)(shi)行)》,上(shang)线运(yun)行“临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)验(yan)期(qi)间安(an)全(quan)风险(xian)(xian)管(guan)(guan)理系统”,对临(lin)床(chuang)(chuang)(chuang)试(shi)(shi)(shi)验(yan)期(qi)间的安(an)全(quan)信(xin)息(xi),如(ru)可疑且(qie)非(fei)预期(qi)严(yan)重不良反应(SUSAR)和研发(fa)(fa)期(qi)间安(an)全(quan)性(xing)更新(xin)(xin)报(bao)告(DSUR)等开展全(quan)过程信(xin)息(xi)系统化的风险(xian)(xian)评(ping)(ping)(ping)估(gu)。

2020年药审(shen)中心接收(shou)来自国内(nei)外的SUSAR个例报告164403份(fen)(涉(she)及病(bing)例为57995例)。其中,来自中国的SUSAR个例报告17243份(fen)(涉(she)及病(bing)例为4647例);接收(shou)DSUR共计(ji)1775份(fen);完成临(lin)(lin)床试(shi)(shi)验(yan)登记(ji)2610项(含新冠(guan)病(bing)毒疫(yi)苗和(he)(he)新冠(guan)肺炎治疗药物(wu))。对18个药物(wu)临(lin)(lin)床试(shi)(shi)验(yan)中存在的安全性(xing)风险(xian),提出了进一(yi)步的风险(xian)控(kong)制(zhi)处理意见,包括(kuo)一(yi)般风险(xian)控(kong)制(zhi)(如修(xiu)改临(lin)(lin)床试(shi)(shi)验(yan)方案、修(xiu)改知情同(tong)意书、修(xiu)改研究(jiu)者手册、补充(chong)完善风险(xian)控(kong)制(zhi)措施)和(he)(he)建议申请人主动暂停(ting)临(lin)(lin)床试(shi)(shi)验(yan)等(deng)。

面(mian)对(dui)突如其(qi)来的(de)严重新(xin)冠肺炎(yan)疫(yi)情,药审(shen)中心(xin)探(tan)索建立了(le)申(shen)请人(ren)进(jin)(jin)行临床(chuang)(chuang)试(shi)验(yan)进(jin)(jin)展(zhan)信(xin)息报(bao)(bao)告机制与(yu)通(tong)道,规(gui)范了(le)相关工(gong)作程序(xu)与(yu)技术要(yao)求,发布了(le)《新(xin)冠肺炎(yan)疫(yi)情期间药物(wu)临床(chuang)(chuang)试(shi)验(yan)管理指(zhi)导(dao)原则(试(shi)行)》,制定了(le)规(gui)范统(tong)一的(de)《应(ying)急审(shen)批(pi)品(pin)种(zhong)临床(chuang)(chuang)试(shi)验(yan)进(jin)(jin)展(zhan)和安(an)全(quan)监(jian)测工(gong)作文件(jian)》。通(tong)过每日(ri)(ri)和每周(zhou)的(de)动态风险沟通(tong)交流(liu),实施(shi)有效的(de)风险监(jian)测与(yu)风险控制。对(dui)2020年2月2日(ri)(ri)至2020年12月31日(ri)(ri)经特别审(shen)批(pi)程序(xu)批(pi)准15个疫(yi)苗(miao)、16个生物(wu)制品(pin)、6个化学(xue)药、2个中药的(de)临床(chuang)(chuang)试(shi)验(yan)共39个品(pin)种(zhong)实施(shi)动态安(an)全(quan)监(jian)测,完成了(le)应(ying)急审(shen)批(pi)新(xin)冠病毒(du)疫(yi)苗(miao)及新(xin)冠肺炎(yan)治疗(liao)药物(wu)临床(chuang)(chuang)试(shi)验(yan)进(jin)(jin)展(zhan)及安(an)全(quan)性(xing)监(jian)测报(bao)(bao)告共195份。

药审中(zhong)心参加《药物(wu)警戒(jie)质量(liang)管(guan)理(li)(li)(li)规范(fan)》(GVP)的(de)(de)(de)起(qi)草工(gong)作(zuo),撰写(xie)临床(chuang)(chuang)试验(yan)(yan)期(qi)间药物(wu)警戒(jie)相关内容和要求。完成《临床(chuang)(chuang)试验(yan)(yan)期(qi)间安全信(xin)息(xi)管(guan)理(li)(li)(li):国际(ji)医学(xue)(xue)科学(xue)(xue)组(zu)织理(li)(li)(li)事会(CIOMS)VI工(gong)作(zuo)组(zu)报告(gao)》的(de)(de)(de)翻译与出(chu)版工(gong)作(zuo),召(zhao)开(kai)“疫(yi)情(qing)期(qi)间临床(chuang)(chuang)试验(yan)(yan)管(guan)理(li)(li)(li)及远程(cheng)智能(neng)技术应(ying)用学(xue)(xue)术交流视频会议”,探索开(kai)展远程(cheng)智能(neng)化临床(chuang)(chuang)试验(yan)(yan)的(de)(de)(de)安全管(guan)理(li)(li)(li)工(gong)作(zuo),稳步(bu)提升临床(chuang)(chuang)试验(yan)(yan)期(qi)间安全信(xin)息(xi)评估(gu)和风险管(guan)理(li)(li)(li)能(neng)力。

(四)继续夯实审(shen)评科学基(ji)础(chu)建设

1.审评质量管理体系建设(she)

发(fa)挥(hui)审(shen)(shen)(shen)(shen)评质量(liang)(liang)管(guan)理(li)体系(xi)对药(yao)品(pin)审(shen)(shen)(shen)(shen)评工(gong)作(zuo)持续有效运(yun)行(xing)的(de)(de)保障作(zuo)用。一方面是(shi)应对新法(fa)律规(gui)章实施对审(shen)(shen)(shen)(shen)评业务工(gong)作(zuo)带(dai)来的(de)(de)风险(xian)和(he)挑战,结合《药(yao)品(pin)注(zhu)册管(guan)理(li)办法(fa)》及其(qi)配套文(wen)件要求,及时组织对《质量(liang)(liang)手册》等体系(xi)文(wen)件进(jin)行(xing)全面修订(ding),加强药(yao)品(pin)审(shen)(shen)(shen)(shen)评业务与质量(liang)(liang)体系(xi)的(de)(de)结合;另一方面是(shi)应对新冠(guan)肺炎疫情(qing)对审(shen)(shen)(shen)(shen)评工(gong)作(zuo)带(dai)来的(de)(de)影响,通(tong)过开(kai)展(zhan)药(yao)审(shen)(shen)(shen)(shen)中心(xin)专项(xiang)内(nei)部(bu)监督检查,充分锻炼药(yao)审(shen)(shen)(shen)(shen)中心(xin)内(nei)审(shen)(shen)(shen)(shen)员队伍,及时发(fa)现(xian)存在(zai)的(de)(de)风险(xian)并组织改进(jin);同时持续开(kai)展(zhan)年度(du)(du)满意(yi)度(du)(du)调查工(gong)作(zuo),收集国(guo)家药(yao)监局和(he)申请人对药(yao)审(shen)(shen)(shen)(shen)中心(xin)在(zai)落(luo)实新注(zhu)册相关要求、应对新冠(guan)肺炎疫情(qing)风险(xian)防(fang)控时的(de)(de)意(yi)见和(he)建议,为提(ti)高(gao)审(shen)(shen)(shen)(shen)评质量(liang)(liang)和(he)效率提(ti)供(gong)思路,发(fa)挥(hui)质量(liang)(liang)体系(xi)对各项(xiang)工(gong)作(zuo)的(de)(de)支(zhi)持作(zuo)用。

2.强(qiang)化审(shen)评信息化建设(she)

为确(que)保各项审(shen)(shen)评(ping)(ping)改革工作(zuo)(zuo)执(zhi)行过(guo)程(cheng)中(zhong)(zhong)的(de)(de)规(gui)范(fan)化(hua)(hua)、标准化(hua)(hua)、数字化(hua)(hua),药(yao)(yao)(yao)审(shen)(shen)中(zhong)(zhong)心大力(li)推(tui)进(jin)信息化(hua)(hua)建设,依(yi)据《药(yao)(yao)(yao)品注(zhu)册(ce)管(guan)理(li)办(ban)(ban)法》和(he)流(liu)(liu)程(cheng)为导向的(de)(de)科学管(guan)理(li)体系(xi),以药(yao)(yao)(yao)品审(shen)(shen)评(ping)(ping)业(ye)务(wu)流(liu)(liu)程(cheng)为基础,立足(zu)工作(zuo)(zuo)实(shi)际,对药(yao)(yao)(yao)品技术审(shen)(shen)评(ping)(ping)系(xi)统(tong)升(sheng)级完(wan)善。新(xin)增发(fa)补(bu)(bu)前的(de)(de)专业(ye)审(shen)(shen)评(ping)(ping)问(wen)询和(he)发(fa)补(bu)(bu)后(hou)的(de)(de)补(bu)(bu)充资料(liao)问(wen)询平台(tai),优(you)化(hua)(hua)沟通(tong)交流(liu)(liu)系(xi)统(tong),加强(qiang)审(shen)(shen)评(ping)(ping)期间与申(shen)请(qing)人(ren)的(de)(de)主(zhu)动(dong)沟通(tong)交流(liu)(liu),促进(jin)审(shen)(shen)评(ping)(ping)业(ye)务(wu)工作(zuo)(zuo)开展;新(xin)增异议处理(li)审(shen)(shen)核(he)和(he)注(zhu)册(ce)检验网(wang)络通(tong)道,调整优(you)先审(shen)(shen)评(ping)(ping)审(shen)(shen)批系(xi)统(tong),强(qiang)化(hua)(hua)审(shen)(shen)核(he)流(liu)(liu)程(cheng)可操作(zuo)(zuo)性(xing),保障审(shen)(shen)评(ping)(ping)审(shen)(shen)批工作(zuo)(zuo)顺(shun)利实(shi)施(shi)。开通(tong)受理(li)网(wang)上预约(yue)通(tong)道,减少人(ren)员流(liu)(liu)动(dong)聚集,有效保障新(xin)冠肺(fei)炎疫情期间申(shen)请(qing)人(ren)受理(li)业(ye)务(wu)的(de)(de)有序办(ban)(ban)理(li);增加突破(po)性(xing)治疗药(yao)(yao)(yao)物程(cheng)序,为鼓(gu)励(li)创新(xin)和(he)加快临床急需品种上市拓宽审(shen)(shen)评(ping)(ping)通(tong)道。通(tong)过(guo)信息化(hua)(hua)手段(duan)助力(li)药(yao)(yao)(yao)品审(shen)(shen)评(ping)(ping)审(shen)(shen)批业(ye)务(wu)管(guan)理(li),强(qiang)化(hua)(hua)网(wang)络信息安全(quan)保障,不(bu)断提升(sheng)药(yao)(yao)(yao)品审(shen)(shen)评(ping)(ping)审(shen)(shen)批工作(zuo)(zuo)质量和(he)效率(lv)。目前药(yao)(yao)(yao)审(shen)(shen)中(zhong)(zhong)心网(wang)站申(shen)请(qing)人(ren)之窗实(shi)名注(zhu)册(ce)申(shen)请(qing)企(qi)业(ye)10674家,基本实(shi)现了药(yao)(yao)(yao)品、原料(liao)药(yao)(yao)(yao)、辅料(liao)、包材(cai)注(zhu)册(ce)申(shen)请(qing)人(ren)网(wang)上业(ye)务(wu)办(ban)(ban)理(li)的(de)(de)全(quan)覆盖。

(五)积极推进流程导向科学管(guan)理体系建(jian)设

为贯彻党的(de)十九届四中(zhong)(zhong)、五中(zhong)(zhong)全(quan)会精(jing)神,加强治理(li)体系(xi)(xi)(xi)、治理(li)能力建(jian)(jian)设(she),以流(liu)程(cheng)导向科(ke)(ke)(ke)学(xue)管(guan)(guan)理(li)体系(xi)(xi)(xi)建(jian)(jian)设(she)为抓手,不断推(tui)进药(yao)品审(shen)(shen)(shen)(shen)评(ping)(ping)体系(xi)(xi)(xi)和(he)审(shen)(shen)(shen)(shen)评(ping)(ping)能力的(de)现代化(hua)。按照(zhao)前期工作计划,药(yao)审(shen)(shen)(shen)(shen)中(zhong)(zhong)心已全(quan)面铺开任务(wu)(wu)受(shou)理(li)、任务(wu)(wu)分配(pei)、专(zhuan)业审(shen)(shen)(shen)(shen)评(ping)(ping)、综合审(shen)(shen)(shen)(shen)评(ping)(ping)、沟通交流(liu)、专(zhuan)家咨(zi)询(xun)、书面发补、核查检验共8个子课题的(de)科(ke)(ke)(ke)学(xue)管(guan)(guan)理(li)体系(xi)(xi)(xi)试点(dian)建(jian)(jian)设(she),并印发《药(yao)审(shen)(shen)(shen)(shen)中(zhong)(zhong)心关(guan)于(yu)运行(xing)药(yao)品专(zhuan)业审(shen)(shen)(shen)(shen)评(ping)(ping)流(liu)程(cheng)导向科(ke)(ke)(ke)学(xue)管(guan)(guan)理(li)体系(xi)(xi)(xi)有关(guan)问题的(de)通知》等8个文件(jian),制定科(ke)(ke)(ke)学(xue)管(guan)(guan)理(li)体系(xi)(xi)(xi)制度制修订计划(含28项制度),截至2020年12月31日(ri)已完成14项。注重试点(dian)建(jian)(jian)设(she)成果的(de)信息化(hua),将各项措施纳入(ru)审(shen)(shen)(shen)(shen)评(ping)(ping)信息系(xi)(xi)(xi)统(tong),增强措施执(zhi)行(xing)的(de)刚(gang)性约束(shu),提(ti)高了科(ke)(ke)(ke)学(xue)监管(guan)(guan)和(he)智慧审(shen)(shen)(shen)(shen)评(ping)(ping)能力。

形(xing)成按(an)季(ji)度汇报机制,定期组织汇报试(shi)(shi)点(dian)(dian)运行情况(kuang)。建(jian)立了(le)(le)(le)改革措施管(guan)理台账,纳入了(le)(le)(le)58项(xiang)需要监督的改革措施,按(an)月度对(dui)每项(xiang)改革措施实施的责任落实、进(jin)展情况(kuang)、新问(wen)题(ti)和解决(jue)建(jian)议予以(yi)一(yi)体化动(dong)态管(guan)理。召开了(le)(le)(le)试(shi)(shi)点(dian)(dian)推(tui)进(jin)座谈会、子课题(ti)结题(ti)座谈会,对(dui)各(ge)子课题(ti)试(shi)(shi)点(dian)(dian)进(jin)度、成效、问(wen)题(ti)等进(jin)行总(zong)结分析。建(jian)立了(le)(le)(le)促进(jin)试(shi)(shi)点(dian)(dian)建(jian)设的长效运行机制,常(chang)态化、一(yi)体化推(tui)进(jin)科学审评(ping)、高效审评(ping)和廉洁审评(ping)。

(六)持续开展ICH工(gong)作(zuo)

切实(shi)(shi)推进我(wo)国药(yao)(yao)品审(shen)(shen)(shen)评审(shen)(shen)(shen)批体系与国际(ji)接轨,参(can)与ICH指(zhi)导(dao)(dao)原则(ze)的(de)国际(ji)协(xie)调。一(yi)是(shi)积极参(can)与ICH议题协(xie)调工(gong)作(zuo)(zuo),自(zi)原国家(jia)(jia)(jia)食品药(yao)(yao)品监(jian)(jian)督(du)管理(li)总局2017年(nian)加(jia)入ICH以(yi)来,已(yi)向36个(ge)(ge)ICH工(gong)作(zuo)(zuo)组(zu)派出了(le)69名(ming)专(zhuan)家(jia)(jia)(jia),2020年(nian)参(can)与ICH工(gong)作(zuo)(zuo)组(zu)电话会437场(chang)。二(er)是(shi)进一(yi)步推进ICH三(san)级指(zhi)导(dao)(dao)原则(ze)实(shi)(shi)施(shi)工(gong)作(zuo)(zuo),国家(jia)(jia)(jia)药(yao)(yao)监(jian)(jian)局共(gong)(gong)(gong)发布了(le)3个(ge)(ge)ICH指(zhi)导(dao)(dao)原则(ze)适用及推荐适用公告。三(san)是(shi)组(zu)织开(kai)展ICH指(zhi)导(dao)(dao)原则(ze)培训(xun)工(gong)作(zuo)(zuo),药(yao)(yao)审(shen)(shen)(shen)中(zhong)心开(kai)展ICH指(zhi)导(dao)(dao)原则(ze)线上培训(xun)共(gong)(gong)(gong)15场(chang),主要围绕(rao)29个(ge)(ge)ICH指(zhi)导(dao)(dao)原则(ze)的(de)技术要点、实(shi)(shi)施(shi)现状、实(shi)(shi)施(shi)过(guo)程(cheng)中(zhong)可(ke)能存在(zai)的(de)问题等内容进行宣贯。培训(xun)对象主要包括(kuo)国家(jia)(jia)(jia)药(yao)(yao)监(jian)(jian)局相关司(si)局、各直属单位、各省级药(yao)(yao)监(jian)(jian)局和省级药(yao)(yao)检机构(gou)的(de)相关工(gong)作(zuo)(zuo)人(ren)员(yuan),共(gong)(gong)(gong)计2723人(ren)观看(kan)培训(xun)直播(bo),4244人(ren)观看(kan)直播(bo)回放。四(si)是(shi)召(zhao)开(kai)ICH指(zhi)导(dao)(dao)原则(ze)和协(xie)调议题研讨(tao)会,为广泛听取行业及学界(jie)专(zhuan)家(jia)(jia)(jia)意见,2020年(nian)药(yao)(yao)审(shen)(shen)(shen)中(zhong)心共(gong)(gong)(gong)召(zhao)开(kai)ICH国内专(zhuan)家(jia)(jia)(jia)研讨(tao)会15场(chang),共(gong)(gong)(gong)计312人(ren)参(can)会。

(七)加强审评队(dui)伍建设和管理

加强审(shen)评(ping)队伍建设,畅通(tong)审(shen)评(ping)员职业发展(zhan)(zhan)通(tong)道,开(kai)展(zhan)(zhan)主审(shen)审(shen)评(ping)员认定(ding)工(gong)作;完善聘(pin)期考核评(ping)价体(ti)系,加强员工(gong)聘(pin)期考核工(gong)作;开(kai)展(zhan)(zhan)补充性(xing)招聘(pin),引进临床、统计等紧缺专(zhuan)业人才;加强员工(gong)培训,组(zu)织开(kai)展(zhan)(zhan)《药品注册管理办(ban)法(fa)》及(ji)配套文(wen)件系列讲座、实(shi)训、英语(yu)口语(yu)等培训。

  九、加强(qiang)服务指(zhi)导、改进工作效(xiao)率和作风

2020年,药(yao)审中(zhong)心驰(chi)而不息强(qiang)化作风建设,积极(ji)服务药(yao)品(pin)高质量发展新要求。

一是紧密围绕(rao)新(xin)冠(guan)(guan)肺炎(yan)疫(yi)情(qing)(qing)防(fang)控(kong)大局(ju),超常规(gui)创新(xin)开展(zhan)应急审(shen)(shen)(shen)评审(shen)(shen)(shen)批(pi),加(jia)强审(shen)(shen)(shen)评服务保障(zhang),全(quan)力做好新(xin)冠(guan)(guan)病(bing)(bing)毒(du)(du)(du)疫(yi)苗(miao)审(shen)(shen)(shen)评过程中(zhong)(zhong)(zhong)(zhong)的(de)(de)各项工作。面对新(xin)冠(guan)(guan)肺炎(yan)疫(yi)情(qing)(qing)对新(xin)冠(guan)(guan)病(bing)(bing)毒(du)(du)(du)疫(yi)苗(miao)药(yao)(yao)(yao)物的(de)(de)急迫需(xu)(xu)求,药(yao)(yao)(yao)审(shen)(shen)(shen)中(zhong)(zhong)(zhong)(zhong)心坚(jian)持(chi)(chi)尊重(zhong)科学规(gui)律,建立早期介入(ru),持(chi)(chi)续跟踪,主(zhu)(zhu)动(dong)(dong)服务、研(yan)(yan)审(shen)(shen)(shen)联动(dong)(dong)的(de)(de)工作机制,始终(zhong)保持(chi)(chi)24小时(shi)(shi)与(yu)企(qi)业(ye)畅(chang)通沟(gou)通的(de)(de)状态,无论多(duo)晚,即使是凌(ling)晨(chen)3-4点钟,都(dou)会(hui)第一时(shi)(shi)间(jian)反(fan)馈研(yan)(yan)发(fa)企(qi)业(ye)诉求,在(zai)推动(dong)(dong)境外临(lin)(lin)床(chuang)试(shi)验(yan)上(shang)强化(hua)(hua)担(dan)当(dang),在(zai)创新(xin)审(shen)(shen)(shen)评审(shen)(shen)(shen)批(pi)中(zhong)(zhong)(zhong)(zhong)挖潜(qian)增效,成功高效推动(dong)(dong)国药(yao)(yao)(yao)集团新(xin)冠(guan)(guan)病(bing)(bing)毒(du)(du)(du)疫(yi)苗(miao)附条件批(pi)准(zhun)上(shang)市和(he)5个疫(yi)苗(miao)品种进(jin)入(ru)Ⅲ期临(lin)(lin)床(chuang)试(shi)验(yan),确(que)(que)保中(zhong)(zhong)(zhong)(zhong)国新(xin)冠(guan)(guan)病(bing)(bing)毒(du)(du)(du)疫(yi)苗(miao)走在(zai)世界(jie)前列,及时(shi)(shi)有(you)力支撑了疫(yi)情(qing)(qing)防(fang)控(kong)大局(ju)。同时(shi)(shi)贯彻落实习近平总书记坚(jian)持(chi)(chi)中(zhong)(zhong)(zhong)(zhong)西医结合、中(zhong)(zhong)(zhong)(zhong)西药(yao)(yao)(yao)并用的(de)(de)重(zhong)要指示(shi)精神,主(zhu)(zhu)动(dong)(dong)对接(jie)临(lin)(lin)床(chuang)救治中(zhong)(zhong)(zhong)(zhong)应用的(de)(de)“三药(yao)(yao)(yao)三方”生(sheng)产(chan)(chan)企(qi)业(ye)和(he)研(yan)(yan)发(fa)单位,积极做好有(you)效中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)方剂转化(hua)(hua)产(chan)(chan)品注册和(he)临(lin)(lin)床(chuang)试(shi)验(yan)申请技术指导,确(que)(que)保中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)第一时(shi)(shi)间(jian)用于(yu)新(xin)冠(guan)(guan)肺炎(yan)患者救治。这些(xie)成果(guo)不仅确(que)(que)保了防(fang)疫(yi)的(de)(de)应急所需(xu)(xu),还为常态化(hua)(hua)疫(yi)情(qing)(qing)防(fang)控(kong)准(zhun)备(bei)了重(zhong)要的(de)(de)战略资源,不仅提振(zhen)了国人战胜疫(yi)情(qing)(qing)的(de)(de)信心,还为全(quan)球疫(yi)情(qing)(qing)防(fang)控(kong)贡献了中(zhong)(zhong)(zhong)(zhong)国力量。

二是(shi)强化(hua)(hua)服(fu)务(wu)申(shen)(shen)(shen)请(qing)(qing)(qing)人(ren)沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)。在新冠肺(fei)炎(yan)疫情防(fang)控常态化(hua)(hua)的(de)(de)(de)(de)情况下(xia),全面(mian)落实(shi)新冠肺(fei)炎(yan)疫情联防(fang)联控措施(shi),最大限度减少人(ren)员(yuan)流(liu)(liu)(liu)(liu)(liu)(liu)动聚集,阻断疫情传播扩散渠道(dao),切实(shi)保障(zhang)申(shen)(shen)(shen)请(qing)(qing)(qing)人(ren)的(de)(de)(de)(de)生命(ming)安全和(he)(he)(he)身体(ti)健(jian)康(kang),暂(zan)停现场咨询(xun)(xun)业务(wu)的(de)(de)(de)(de)同时(shi)(shi)开(kai)通(tong)了电话咨询(xun)(xun)业务(wu)。增设立了8个联系邮箱,申(shen)(shen)(shen)请(qing)(qing)(qing)人(ren)可(ke)以邮件咨询(xun)(xun)问题并提(ti)供在审(shen)品(pin)种受理(li)(li)号(hao)等信(xin)息,项目管(guan)理(li)(li)人(ren)员(yuan)将在3个工作(zuo)日内与该受理(li)(li)号(hao)相关(guan)的(de)(de)(de)(de)申(shen)(shen)(shen)请(qing)(qing)(qing)人(ren)进行联系。通(tong)过不断丰富(fu)和(he)(he)(he)拓展沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)的(de)(de)(de)(de)渠道(dao)和(he)(he)(he)方式,服(fu)务(wu)和(he)(he)(he)便利申(shen)(shen)(shen)请(qing)(qing)(qing)人(ren);为(wei)鼓励创新,更好地体(ti)现沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)的(de)(de)(de)(de)服(fu)务(wu)属性(xing),结(jie)合《药(yao)品(pin)注册管(guan)理(li)(li)办(ban)法》,从药(yao)物(wu)研制规(gui)律和(he)(he)(he)注册要求(qiu)出发(fa),秉持为(wei)药(yao)品(pin)注册申(shen)(shen)(shen)请(qing)(qing)(qing)人(ren)服(fu)务(wu)的(de)(de)(de)(de)原则,修(xiu)订后发(fa)布(bu)了《药(yao)物(wu)研发(fa)与技术审(shen)评沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)管(guan)理(li)(li)办(ban)法》。在保证受试者安全性(xing)的(de)(de)(de)(de)基础上,将Ⅱ类会议划分为(wei)依法应(ying)沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)、原则上应(ying)当(dang)沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)、可(ke)以沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)三类情形,并明确和(he)(he)(he)细化(hua)(hua)了三类沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)的(de)(de)(de)(de)情形和(he)(he)(he)要求(qiu);为(wei)提(ti)高(gao)沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)申(shen)(shen)(shen)请(qing)(qing)(qing)办(ban)理(li)(li)的(de)(de)(de)(de)可(ke)预见性(xing)和(he)(he)(he)效(xiao)率,药(yao)审(shen)中(zhong)心通(tong)过持续优化(hua)(hua)沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)管(guan)理(li)(li),细化(hua)(hua)环节时(shi)(shi)限控制,确保了申(shen)(shen)(shen)请(qing)(qing)(qing)人(ren)能够尽快享受到(dao)优质的(de)(de)(de)(de)沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)服(fu)务(wu),努力(li)满足申(shen)(shen)(shen)请(qing)(qing)(qing)人(ren)逐年(nian)增加的(de)(de)(de)(de)沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)需求(qiu),将2020年(nian)沟(gou)通(tong)交(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)申(shen)(shen)(shen)请(qing)(qing)(qing)办(ban)理(li)(li)量提(ti)升至2019年(nian)办(ban)理(li)(li)量的(de)(de)(de)(de)1.31倍(bei),这也是(shi)2016年(nian)办(ban)理(li)(li)量的(de)(de)(de)(de)11.35倍(bei)。

三(san)是持(chi)续改(gai)善内部工作(zuo)作(zuo)风(feng),提(ti)高(gao)(gao)(gao)工作(zuo)效率。这(zhei)一年(nian)药(yao)审(shen)中(zhong)心继续深化(hua)(hua)审(shen)评(ping)(ping)(ping)(ping)审(shen)批(pi)制(zhi)度改(gai)革,持(chi)续优化(hua)(hua)审(shen)评(ping)(ping)(ping)(ping)流程,严格(ge)时(shi)限管(guan)理,实施审(shen)评(ping)(ping)(ping)(ping)任务分(fen)析(xi)会制(zhi)度,加强项目督导,鼓(gu)励(li)药(yao)品(pin)(pin)(pin)(pin)创新(xin)(xin),推动仿(fang)制(zhi)药(yao)高(gao)(gao)(gao)质量(liang)发展(zhan),审(shen)评(ping)(ping)(ping)(ping)质量(liang)和(he)效率有了极大地提(ti)升,2020年(nian)全年(nian)审(shen)结任务整(zheng)体按时(shi)完(wan)(wan)成率创历(li)史(shi)新(xin)(xin)高(gao)(gao)(gao)。药(yao)品(pin)(pin)(pin)(pin)审(shen)评(ping)(ping)(ping)(ping)审(shen)批(pi)的(de)可预期性(xing)进一步(bu)提(ti)高(gao)(gao)(gao),顺利完(wan)(wan)成《十(shi)三(san)五药(yao)品(pin)(pin)(pin)(pin)安全规(gui)划》涉及药(yao)品(pin)(pin)(pin)(pin)审(shen)评(ping)(ping)(ping)(ping)审(shen)批(pi)改(gai)革目标。通过(guo)5年(nian)来深化(hua)(hua)药(yao)品(pin)(pin)(pin)(pin)审(shen)评(ping)(ping)(ping)(ping)审(shen)批(pi)制(zhi)度改(gai)革的(de)不懈努力(li),药(yao)审(shen)中(zhong)心实现了量(liang)变到质变的(de)飞跃(yue),药(yao)品(pin)(pin)(pin)(pin)平均审(shen)评(ping)(ping)(ping)(ping)时(shi)限大幅压缩,审(shen)评(ping)(ping)(ping)(ping)能力(li)大幅提(ti)升,一大批(pi)创新(xin)(xin)药(yao)、临(lin)床(chuang)急需药(yao)获批(pi)上市,累计通过(guo)和(he)视同(tong)通过(guo)一致(zhi)性(xing)评(ping)(ping)(ping)(ping)价审(shen)评(ping)(ping)(ping)(ping)的(de)品(pin)(pin)(pin)(pin)种(zhong)已达445个,为(wei)十(shi)四五药(yao)品(pin)(pin)(pin)(pin)审(shen)评(ping)(ping)(ping)(ping)事业的(de)发展(zhan)奠(dian)定了坚实的(de)基础。

药审中心将深入梳理在提(ti)高审评(ping)效(xiao)率、创新审评(ping)方(fang)式等方(fang)面的(de)经验做法,使应(ying)急状态(tai)(tai)下的(de)临时性措施(shi),有序地上(shang)升为(wei)常(chang)态(tai)(tai)化审评(ping)工作长效(xiao)机(ji)制,将被(bei)动(dong)选择但被(bei)实(shi)践证(zheng)明长期有效(xiao)的(de)方(fang)法转化为(wei)常(chang)态(tai)(tai)化条件下提(ti)高审评(ping)能力(li)的(de)主(zhu)动(dong)选择。

十、加大药(yao)品审评(ping)审批信息公开力度(du)

药审(shen)(shen)中(zhong)心持续推进技(ji)(ji)术(shu)审(shen)(shen)评(ping)(ping)的(de)(de)(de)信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)开(kai)(kai)(kai)(kai)(kai)工(gong)作,提(ti)高(gao)药品(pin)(pin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批工(gong)作透明(ming)度(du)(du)。一是(shi)完(wan)善信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)开(kai)(kai)(kai)(kai)(kai)制(zhi)度(du)(du),发布了(le)《药品(pin)(pin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)开(kai)(kai)(kai)(kai)(kai)管(guan)理办法》,明(ming)确信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)开(kai)(kai)(kai)(kai)(kai)的(de)(de)(de)范围、种类、时限(xian)等(deng)要求,为(wei)做(zuo)好信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)开(kai)(kai)(kai)(kai)(kai)工(gong)作提(ti)供了(le)制(zhi)度(du)(du)依据(ju)。二(er)是(shi)大力推动新药技(ji)(ji)术(shu)审(shen)(shen)评(ping)(ping)报告的(de)(de)(de)公(gong)开(kai)(kai)(kai)(kai)(kai),自(zi)开(kai)(kai)(kai)(kai)(kai)展(zhan)工(gong)作以来已完(wan)成公(gong)开(kai)(kai)(kai)(kai)(kai)新药技(ji)(ji)术(shu)审(shen)(shen)评(ping)(ping)报告316个(ge),指导行(xing)业研发,更好的(de)(de)(de)服务(wu)药品(pin)(pin)注(zhu)册申(shen)请(qing)(qing)人和(he)公(gong)众(zhong)。三是(shi)加大技(ji)(ji)术(shu)审(shen)(shen)评(ping)(ping)过程信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)开(kai)(kai)(kai)(kai)(kai)力度(du)(du),通(tong)过药审(shen)(shen)中(zhong)心网(wang)站向申(shen)请(qing)(qing)人进一步(bu)公(gong)开(kai)(kai)(kai)(kai)(kai)了(le)审(shen)(shen)评(ping)(ping)排队信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)、优先审(shen)(shen)评(ping)(ping)的(de)(de)(de)状态信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)、沟通(tong)交流(liu)申(shen)请(qing)(qing)及(ji)(ji)办理信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)等(deng)信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi),新增了(le)“突(tu)破(po)(po)性治疗公(gong)示”的(de)(de)(de)栏目,公(gong)开(kai)(kai)(kai)(kai)(kai)了(le)“拟(ni)突(tu)破(po)(po)性治疗品(pin)(pin)种、异议论证结果(guo)”等(deng)信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi)。方便申(shen)请(qing)(qing)人查询(xun)信(xin)(xin)(xin)(xin)(xin)息(xi)(xi)(xi)(xi)(xi),进一步(bu)拓宽了(le)申(shen)请(qing)(qing)人的(de)(de)(de)沟通(tong)渠道,及(ji)(ji)时回应社会关切,提(ti)高(gao)了(le)审(shen)(shen)评(ping)(ping)审(shen)(shen)批工(gong)作的(de)(de)(de)透明(ming)度(du)(du)。

 十一、2021年重点工作安排

2020年(nian)(nian),药(yao)品审(shen)(shen)评工作(zuo)(zuo)取(qu)得了一(yi)定进(jin)展,但仍存在(zai)着一(yi)些问题(ti):一(yi)是注册(ce)申请申报(bao)量,特别是创新药(yao)申报(bao)量连年(nian)(nian)递增,药(yao)审(shen)(shen)中心(xin)审(shen)(shen)评队伍规模结构(gou)与(yu)审(shen)(shen)评任务量配比失衡;二是高层(ceng)次及(ji)紧缺专业人(ren)才引进(jin)难(nan)、新进(jin)审(shen)(shen)评员急需长期专业培训等审(shen)(shen)评能(neng)力现(xian)代(dai)化短(duan)板(ban)问题(ti)突出;三是新旧注册(ce)相关(guan)规定过渡期间,应(ying)及(ji)时研究问题(ti),给(ji)予(yu)相应(ying)的解决措施(shi)。2021年(nian)(nian)药(yao)审(shen)(shen)中心(xin)将紧密(mi)围绕国家药(yao)监(jian)局工作(zuo)(zuo)部署,重(zhong)点开展以下工作(zuo)(zuo):

(一(yi))积极推动制度体系建(jian)设

完善(shan)新《药品(pin)注(zhu)册管理办(ban)法》配套文件,做好新旧注(zhu)册相关规定过(guo)渡(du)期相关工作(zuo),稳妥处理历史问题;继(ji)续(xu)开展(zhan)药品(pin)审评(ping)流程导向科(ke)(ke)学管理体(ti)(ti)系建设(she)工作(zuo),构(gou)建长效运行机制(zhi),完善(shan)药品(pin)技(ji)术指导原则体(ti)(ti)系,规范中心(xin)制(zhi)度体(ti)(ti)系建设(she),推动审评(ping)体(ti)(ti)系和审评(ping)能(neng)力(li)现代(dai)化;深(shen)入推进监管科(ke)(ke)学研究(jiu)(jiu),深(shen)化与高校、科(ke)(ke)研院所合作(zuo),加(jia)快首(shou)批重点项目研究(jiu)(jiu)成(cheng)果转化。

(二)毫不放松做好应(ying)急审(shen)评审(shen)批工(gong)作

始终保(bao)持应(ying)急(ji)工作状态,完(wan)善研审(shen)联动机制,坚持特(te)事特(te)办(ban),促进包括中医药、抗体药物等新(xin)冠(guan)(guan)肺(fei)炎治疗(liao)药物的研发(fa);持续做好应(ying)急(ji)审(shen)评(ping)(ping)审(shen)批核(he)查检验(yan)协调工作;继续强化服务(wu)指(zhi)导(dao),持续跟进各条技术路线(xian)新(xin)冠(guan)(guan)病(bing)毒疫苗研发(fa)进展,依(yi)(yi)法依(yi)(yi)规严格审(shen)评(ping)(ping),继续做好新(xin)冠(guan)(guan)肺(fei)炎治疗(liao)药物和新(xin)冠(guan)(guan)病(bing)毒疫苗审(shen)评(ping)(ping)工作;全面(mian)总结应(ying)急(ji)审(shen)评(ping)(ping)审(shen)批工作经验(yan),完(wan)善审(shen)评(ping)(ping)审(shen)批制度体系,进一步激发(fa)药品(pin)创新(xin)发(fa)展活(huo)力。

(三(san))加快建(jian)立符合中医药(yao)特(te)点的中药(yao)审评机制体系

构建中(zhong)(zhong)(zhong)医药(yao)(yao)理论、中(zhong)(zhong)(zhong)药(yao)(yao)人(ren)用经验和临床试验“三结合(he)”的(de)(de)审(shen)(shen)评证(zheng)据体系,组建古(gu)代经典名(ming)方(fang)中(zhong)(zhong)(zhong)药(yao)(yao)复(fu)方(fang)制剂专家(jia)审(shen)(shen)评委员会(hui),扎实推进中(zhong)(zhong)(zhong)药(yao)(yao)审(shen)(shen)评审(shen)(shen)批改革(ge);参(can)考(kao)“三方(fang)”审(shen)(shen)评审(shen)(shen)批经验,逐(zhu)步探(tan)索(suo)适合(he)古(gu)代经典名(ming)方(fang)的(de)(de)中(zhong)(zhong)(zhong)药(yao)(yao)复(fu)方(fang)制剂的(de)(de)审(shen)(shen)评指导(dao)原(yuan)则和标(biao)准,完善符合(he)中(zhong)(zhong)(zhong)医药(yao)(yao)特点的(de)(de)技(ji)术指导(dao)原(yuan)则;加快确有临床价(jia)值的(de)(de)中(zhong)(zhong)(zhong)药(yao)(yao)新药(yao)(yao)审(shen)(shen)批,发(fa)挥中(zhong)(zhong)(zhong)医药(yao)(yao)在疾病防治(zhi)中(zhong)(zhong)(zhong)的(de)(de)独特优势(shi)。

(四)持(chi)续深化审(shen)评审(shen)批(pi)制度改革

巩固按时限审(shen)评(ping)改革成(cheng)果,完(wan)善(shan)项目管理(li)(li)工作(zuo)机制;完(wan)善(shan)专(zhuan)家咨询(xun)委员会(hui)制度(du),解决争议(yi)重大疑(yi)难问题,利用(yong)(yong)巡视整改要求(qiu)推动制度(du)改革,加大审(shen)评(ping)审(shen)批信息公开(kai)力度(du),优化沟通交流制度(du),提高(gao)审(shen)评(ping)服务水平;细(xi)化上市药品变更管理(li)(li)技术要求(qiu),指导(dao)药品上市许可持(chi)有人(ren)开(kai)展上市后持(chi)续研究;进一步加强(qiang)临床(chuang)试(shi)验(yan)期(qi)间安全性(xing)评(ping)价(jia)及药物警戒体系(xi)建设;持(chi)续推进ICH指导(dao)原则在国内转(zhuan)化实施(shi);加快审(shen)评(ping)数字化建设,推进eCTD系(xi)统使用(yong)(yong)。加快推进研发(fa)生产(chan)主(zhu)体信息库建设。

(五(wu))坚持鼓励药(yao)品(pin)研发创新

持续完善药(yao)(yao)(yao)(yao)(yao)品审(shen)评审(shen)批(pi)制度(du)体(ti)系,坚(jian)持以安(an)全有效为根本标(biao)准(zhun),优化审(shen)评资源配(pei)置,在创(chuang)新(xin)药(yao)(yao)(yao)(yao)(yao)审(shen)评中探(tan)索实(shi)施(shi)“提前(qian)介入”“研审(shen)联动(dong)”“平行检验(yan)”“前(qian)置检验(yan)”等方式;继续鼓励新(xin)药(yao)(yao)(yao)(yao)(yao)好药(yao)(yao)(yao)(yao)(yao)研发创(chuang)新(xin),强化沟(gou)通交流,优先配(pei)置资源,进一步细化和实(shi)施(shi)突破(po)性治疗药(yao)(yao)(yao)(yao)(yao)物、附条件批(pi)准(zhun)、优先审(shen)评、特别(bie)审(shen)批(pi)等加(jia)快审(shen)评程序,加(jia)快临床急需境外新(xin)药(yao)(yao)(yao)(yao)(yao)、罕见病用(yong)药(yao)(yao)(yao)(yao)(yao)、儿(er)童用(yong)药(yao)(yao)(yao)(yao)(yao)、重(zhong)大传染病用(yong)药(yao)(yao)(yao)(yao)(yao)等上(shang)市(shi)速度(du)。

(六)推动仿(fang)制(zhi)药(yao)高质量发展

持续完善仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)参(can)比制(zhi)(zhi)(zhi)剂遴选,坚持标准不降低的原则(ze),稳妥(tuo)有序推进(jin)仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)质量和疗(liao)效(xiao)一(yi)致(zhi)性(xing)评(ping)价(jia);进(jin)一(yi)步完善仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)相关技术(shu)指(zhi)导原则(ze)和标准体(ti)系(xi)建设;以建立审评(ping)要点体(ti)系(xi)为(wei)基(ji)础,推动(dong)仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)审评(ping)科学规范、标准,提高仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)审评(ping)质量和效(xiao)率(lv)。

(七)优化(hua)人(ren)才队伍建设(she)

按照国家药监(jian)局统一(yi)(yi)部(bu)署(shu),全力指(zhi)导和(he)推进长三(san)角、大湾区两个分中心建设;以专业培训为抓手,进一(yi)(yi)步(bu)加强药品审(shen)评(ping)队(dui)伍(wu)(wu)能力建设;配合药品审(shen)评(ping)业务(wu),积极开展人员(yuan)招(zhao)聘工作,加强队(dui)伍(wu)(wu)建设;进一(yi)(yi)步(bu)加强专业技术队(dui)伍(wu)(wu)建设,完善(shan)专业技术队(dui)伍(wu)(wu)晋升等制度;进一(yi)(yi)步(bu)严(yan)格(ge)人员(yuan)招(zhao)聘条(tiao)件,规范人员(yuan)离职,严(yan)格(ge)队(dui)伍(wu)(wu)管理。

 十二、结语

大鹏一日(ri)同风起,扶摇直上九万里。2021年是实(shi)施“十四(si)五(wu)”规(gui)划的(de)开局(ju)(ju)之年,药(yao)(yao)(yao)(yao)审中(zhong)心(xin)将在国(guo)(guo)家药(yao)(yao)(yao)(yao)监局(ju)(ju)的(de)坚(jian)(jian)强(qiang)领导(dao)下,坚(jian)(jian)持(chi)以(yi)(yi)习近平(ping)(ping)新时(shi)代(dai)中(zhong)国(guo)(guo)特色社(she)会主(zhu)义思(si)想为(wei)(wei)指导(dao),全(quan)(quan)面贯彻党的(de)十九大和十九届(jie)二中(zhong)、三中(zhong)、四(si)中(zhong)、五(wu)中(zhong)全(quan)(quan)会精神,坚(jian)(jian)持(chi)以(yi)(yi)人民(min)为(wei)(wei)中(zhong)心(xin)的(de)发(fa)(fa)展(zhan)(zhan)思(si)想,按照立(li)足(zu)新发(fa)(fa)展(zhan)(zhan)阶段,贯彻新发(fa)(fa)展(zhan)(zhan)理念,构建新发(fa)(fa)展(zhan)(zhan)格局(ju)(ju)的(de)要求,以(yi)(yi)习近平(ping)(ping)总书记“四(si)个最严”要求为(wei)(wei)根本遵(zun)循,以(yi)(yi)鼓励(li)创新推动药(yao)(yao)(yao)(yao)品(pin)(pin)高质量发(fa)(fa)展(zhan)(zhan)为(wei)(wei)主(zhu)题,以(yi)(yi)深(shen)化(hua)(hua)(hua)药(yao)(yao)(yao)(yao)品(pin)(pin)审评(ping)审批制度改革为(wei)(wei)主(zhu)线,以(yi)(yi)满足(zu)人民(min)日(ri)益增长的(de)美好(hao)生活需要为(wei)(wei)根本目的(de),以(yi)(yi)建设国(guo)(guo)际化(hua)(hua)(hua)现代(dai)化(hua)(hua)(hua)科(ke)学化(hua)(hua)(hua)药(yao)(yao)(yao)(yao)品(pin)(pin)审评(ping)机构为(wei)(wei)根本动力,坚(jian)(jian)持(chi)为(wei)(wei)国(guo)(guo)为(wei)(wei)民(min)履职(zhi)尽责(ze),切实(shi)保障药(yao)(yao)(yao)(yao)品(pin)(pin)安(an)全(quan)(quan)有效可及(ji),保护和促进公(gong)众健康,努(nu)力实(shi)现“十四(si)五(wu)”时(shi)期(qi)发(fa)(fa)展(zhan)(zhan)开好(hao)局(ju)(ju)、起好(hao)步,以(yi)(yi)优(you)异成绩(ji)迎接中(zhong)国(guo)(guo)共产党成立(li)100周年。

 

 

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来(lai)源(yuan):国家药品监督(du)管理(li)局网站,具体详见:http://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20210621142436183.html