2020年度药品审评报告

时间:2020-06-22

2020年(nian)是极不平(ping)凡的(de)(de)一(yi)年(nian),面(mian)对突(tu)如(ru)其来(lai)的(de)(de)新(xin)(xin)冠(guan)(guan)肺(fei)炎(yan)疫(yi)情(qing)(qing)(qing),国(guo)(guo)家(jia)药(yao)(yao)(yao)(yao)(yao)品(pin)监(jian)督(du)(du)管理(li)局药(yao)(yao)(yao)(yao)(yao)品(pin)审(shen)(shen)评(ping)(ping)中心(xin)(以下简(jian)称(cheng)药(yao)(yao)(yao)(yao)(yao)审(shen)(shen)中心(xin))在国(guo)(guo)家(jia)药(yao)(yao)(yao)(yao)(yao)品(pin)监(jian)督(du)(du)管理(li)局(以下简(jian)称(cheng)国(guo)(guo)家(jia)药(yao)(yao)(yao)(yao)(yao)监(jian)局)的(de)(de)坚(jian)强领导下,认真学习贯(guan)(guan)彻习近平(ping)总(zong)书记重要讲话和重要指示(shi)批(pi)示(shi)精神,闻令而动、尽锐出战(zhan),坚(jian)持人民至上(shang)(shang)、生命至上(shang)(shang),超常(chang)规建立“早(zao)期介入、持续跟踪、主动服务、研审(shen)(shen)联动”全天候应急(ji)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)工(gong)作(zuo)(zuo)机制(zhi),加(jia)速(su)推动新(xin)(xin)冠(guan)(guan)病毒疫(yi)苗(miao)和新(xin)(xin)冠(guan)(guan)肺(fei)炎(yan)治疗药(yao)(yao)(yao)(yao)(yao)物研发上(shang)(shang)市,充分发挥技术审(shen)(shen)评(ping)(ping)对疫(yi)情(qing)(qing)(qing)防(fang)控的(de)(de)科技支撑作(zuo)(zuo)用(yong);主动服务于药(yao)(yao)(yao)(yao)(yao)监(jian)系(xi)统工(gong)作(zuo)(zuo)大局,紧(jin)紧(jin)围绕(rao)落实党中央国(guo)(guo)务院审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)制(zhi)度改革、贯(guan)(guan)彻《药(yao)(yao)(yao)(yao)(yao)品(pin)管理(li)法(fa)》《疫(yi)苗(miao)管理(li)法(fa)》《药(yao)(yao)(yao)(yao)(yao)品(pin)注册(ce)管理(li)办法(fa)》、推动审(shen)(shen)评(ping)(ping)体系(xi)和审(shen)(shen)评(ping)(ping)能力现(xian)代化,统筹推进疫(yi)情(qing)(qing)(qing)防(fang)控和依(yi)法(fa)依(yi)规科学审(shen)(shen)评(ping)(ping)工(gong)作(zuo)(zuo),不断提高审(shen)(shen)评(ping)(ping)质量和效(xiao)(xiao)率(lv),不断加(jia)快新(xin)(xin)药(yao)(yao)(yao)(yao)(yao)研发上(shang)(shang)市步伐(fa),为疫(yi)情(qing)(qing)(qing)防(fang)控和满足临床急(ji)需提供(gong)有效(xiao)(xiao)药(yao)(yao)(yao)(yao)(yao)物保(bao)障、为医药(yao)(yao)(yao)(yao)(yao)产业高质量发展提供(gong)有力促进作(zuo)(zuo)用(yong),保(bao)障了人民群众用(yong)药(yao)(yao)(yao)(yao)(yao)安全有效(xiao)(xiao)可(ke)及,药(yao)(yao)(yao)(yao)(yao)品(pin)审(shen)(shen)评(ping)(ping)事业得(de)到(dao)新(xin)(xin)发展、迈上(shang)(shang)新(xin)(xin)台(tai)阶、开创新(xin)(xin)局面(mian)。 

一(yi)、药品注册申请审评审批情况

(一)总体完(wan)成情况

1.全年审评审批完成情(qing)况(kuang)

2020年,根据(ju)《药(yao)(yao)品注(zhu)册管(guan)(guan)理(li)办法(fa)》(国家市场监督(du)管(guan)(guan)理(li)总局令第27号(hao))、《国家药(yao)(yao)监局关(guan)于实施<药(yao)(yao)品注(zhu)册管(guan)(guan)理(li)办法(fa)>有关(guan)事宜的(de)(de)(de)公告》(2020年第46号(hao),以下简(jian)称46号(hao)公告)及《药(yao)(yao)品注(zhu)册管(guan)(guan)理(li)办法(fa)》相关(guan)配套文件(jian)(jian),药(yao)(yao)审(shen)(shen)(shen)(shen)中心完成(cheng)中药(yao)(yao)(包括民族药(yao)(yao),下同)、化学(xue)药(yao)(yao)、生物(wu)制(zhi)品各类(lei)注(zhu)册申(shen)请(qing)(qing)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)共(gong)11582件(jian)(jian)(含器械(xie)组合产品4件(jian)(jian),以受理(li)号(hao)计,下同),较(jiao)2019年增(zeng)长32.67%(如无(wu)说明,以注(zhu)册申(shen)请(qing)(qing)件(jian)(jian)数计,下同)。其中,完成(cheng)需技(ji)术(shu)审(shen)(shen)(shen)(shen)评(ping)的(de)(de)(de)注(zhu)册申(shen)请(qing)(qing)8606件(jian)(jian)(含5674件(jian)(jian)需药(yao)(yao)审(shen)(shen)(shen)(shen)中心技(ji)术(shu)审(shen)(shen)(shen)(shen)评(ping)和(he)行(xing)政(zheng)审(shen)(shen)(shen)(shen)批(pi)(pi)注(zhu)册申(shen)请(qing)(qing)),较(jiao)2019年增(zeng)长26.24%;完成(cheng)直接行(xing)政(zheng)审(shen)(shen)(shen)(shen)批(pi)(pi)(无(wu)需技(ji)术(shu)审(shen)(shen)(shen)(shen)评(ping),下同)的(de)(de)(de)注(zhu)册申(shen)请(qing)(qing)2972件(jian)(jian)。2020年底正在审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)和(he)等待(dai)(dai)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)的(de)(de)(de)注(zhu)册申(shen)请(qing)(qing)已由2015年9月(yue)高(gao)峰时(shi)的(de)(de)(de)近22000件(jian)(jian)降至4882件(jian)(jian)(不(bu)含完成(cheng)技(ji)术(shu)审(shen)(shen)(shen)(shen)评(ping)因申(shen)报资料缺陷等待(dai)(dai)申(shen)请(qing)(qing)人回复补充资料的(de)(de)(de)注(zhu)册申(shen)请(qing)(qing))。

完成8606件(jian)需技(ji)术(shu)审(shen)(shen)(shen)评的(de)药品(pin)注(zhu)(zhu)(zhu)册申(shen)(shen)(shen)请中,化(hua)学(xue)药注(zhu)(zhu)(zhu)册申(shen)(shen)(shen)请为6778件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长25.22%;中药注(zhu)(zhu)(zhu)册申(shen)(shen)(shen)请418件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长39.33%;生物制(zhi)品(pin)注(zhu)(zhu)(zhu)册申(shen)(shen)(shen)请1410件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长27.72%;化(hua)学(xue)药注(zhu)(zhu)(zhu)册申(shen)(shen)(shen)请约占全部技(ji)术(shu)审(shen)(shen)(shen)评完成量的(de)78.76%。2016-2020年(nian)中药、生物制(zhi)品(pin)、化(hua)学(xue)药注(zhu)(zhu)(zhu)册申(shen)(shen)(shen)请审(shen)(shen)(shen)评审(shen)(shen)(shen)批完成情况详见图1。

 

 

  药(yao)(yao)审(shen)(shen)中心完(wan)(wan)(wan)成(cheng)(cheng)需(xu)技术审(shen)(shen)评(ping)(ping)的8606件(jian)(jian)注册申(shen)(shen)请(qing)(qing)(qing)(qing)中,完(wan)(wan)(wan)成(cheng)(cheng)新(xin)药(yao)(yao)临床试验(IND)申(shen)(shen)请(qing)(qing)(qing)(qing)审(shen)(shen)评(ping)(ping)1561件(jian)(jian),较2019年(nian)增长(zhang)55.94%;完(wan)(wan)(wan)成(cheng)(cheng)新(xin)药(yao)(yao)上(shang)市申(shen)(shen)请(qing)(qing)(qing)(qing)(NDA)审(shen)(shen)评(ping)(ping)289件(jian)(jian),完(wan)(wan)(wan)成(cheng)(cheng)仿制(zhi)药(yao)(yao)上(shang)市申(shen)(shen)请(qing)(qing)(qing)(qing)(ANDA)审(shen)(shen)评(ping)(ping)1700件(jian)(jian);完(wan)(wan)(wan)成(cheng)(cheng)仿制(zhi)药(yao)(yao)质量和疗效一致性评(ping)(ping)价(以下简称一致性评(ping)(ping)价)申(shen)(shen)请(qing)(qing)(qing)(qing)(以补(bu)充申(shen)(shen)请(qing)(qing)(qing)(qing)途径申(shen)(shen)报)1136件(jian)(jian),较2019年(nian)增长(zhang)103.22%;完(wan)(wan)(wan)成(cheng)(cheng)补(bu)充申(shen)(shen)请(qing)(qing)(qing)(qing)技术审(shen)(shen)评(ping)(ping)3250件(jian)(jian),较2019年(nian)增长(zhang)24.19%。2016-2020年(nian)各类注册申(shen)(shen)请(qing)(qing)(qing)(qing)审(shen)(shen)评(ping)(ping)完(wan)(wan)(wan)成(cheng)(cheng)情(qing)况详见图2。

 

3.审(shen)评通过(guo)情况

2020年,药审(shen)中心审(shen)评(ping)通(tong)过(guo)批准IND申请1435件,较(jiao)2019年增(zeng)长(zhang)54.97%;审(shen)评(ping)通(tong)过(guo)NDA 208件,较(jiao)2019年增(zeng)长(zhang)26.83%;审(shen)评(ping)通(tong)过(guo)ANDA 918件;审(shen)评(ping)通(tong)过(guo)批准一致性评(ping)价申请577件,较(jiao)2019年增(zeng)长(zhang)121.92%。

药审(shen)中心(xin)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(jing)外生产原研药品(pin)(pin)NDA 72个品(pin)(pin)种(含(han)新增适应症品(pin)(pin)种),具体品(pin)(pin)种详见(jian)附件(jian)1、2。

4.审结(jie)注册申请任务按时(shi)限(xian)完成情(qing)况

2020年(nian),药审(shen)中(zhong)心持(chi)续优化审(shen)评(ping)(ping)(ping)流程,严格审(shen)评(ping)(ping)(ping)时(shi)(shi)限(xian)管理,加强项目督(du)导,加快审(shen)评(ping)(ping)(ping)速度,整(zheng)体(ti)审(shen)评(ping)(ping)(ping)任务(wu)(wu)(wu)和(he)重(zhong)点序列审(shen)评(ping)(ping)(ping)任务(wu)(wu)(wu)按(an)(an)时(shi)(shi)限(xian)完(wan)成(cheng)率(lv)均取得显(xian)著提(ti)升。全年(nian)审(shen)结(jie)注(zhu)(zhu)册(ce)申(shen)(shen)(shen)请任务(wu)(wu)(wu)整(zheng)体(ti)按(an)(an)时(shi)(shi)限(xian)完(wan)成(cheng)率(lv)为(wei)94.48%,其(qi)中(zhong)临床急需(xu)境外已(yi)上市新药注(zhu)(zhu)册(ce)申(shen)(shen)(shen)请审(shen)结(jie)任务(wu)(wu)(wu)整(zheng)体(ti)按(an)(an)时(shi)(shi)限(xian)完(wan)成(cheng)率(lv)为(wei)100%,按(an)(an)默示(shi)许可受理注(zhu)(zhu)册(ce)申(shen)(shen)(shen)请的审(shen)结(jie)任务(wu)(wu)(wu)整(zheng)体(ti)按(an)(an)时(shi)(shi)限(xian)完(wan)成(cheng)率(lv)为(wei)99.87%,直接(jie)行(xing)政审(shen)批(pi)的注(zhu)(zhu)册(ce)申(shen)(shen)(shen)请100%在法定的20个工(gong)作日内完(wan)成(cheng),且审(shen)批(pi)平均用时(shi)(shi)11.8个工(gong)作日。各类注(zhu)(zhu)册(ce)申(shen)(shen)(shen)请任务(wu)(wu)(wu)按(an)(an)时(shi)(shi)限(xian)完(wan)成(cheng)情况(kuang)详(xiang)见(jian)表1。

 

  2020年(nian)(nian)的NDA年(nian)(nian)度(du)整体按(an)时限(xian)完(wan)(wan)成(cheng)(cheng)率(lv)已经有了(le)很大的提升(sheng),例如:NDA按(an)时限(xian)完(wan)(wan)成(cheng)(cheng)率(lv)在2020年(nian)(nian)12月(yue)突(tu)破80%,提升(sheng)至87.5%;ANDA按(an)时限(xian)完(wan)(wan)成(cheng)(cheng)率(lv)在2020年(nian)(nian)12月(yue)突(tu)破90%,达到(dao)93.85%;纳入优先审(shen)评程(cheng)序的注册申请按(an)时限(xian)完(wan)(wan)成(cheng)(cheng)率(lv)在2020年(nian)(nian)10-12月(yue)的月(yue)度(du)按(an)时限(xian)完(wan)(wan)成(cheng)(cheng)率(lv)连续达到(dao)90%以上,取得历史性突(tu)破。

(二)中药注册申请审评完成情(qing)况

1.总体情况

2020年(nian),药审(shen)中(zhong)心(xin)完(wan)(wan)(wan)成审(shen)评的中(zhong)药注册申请418件(jian)。其中(zhong),完(wan)(wan)(wan)成IND申请37件(jian),完(wan)(wan)(wan)成NDA 8件(jian),完(wan)(wan)(wan)成ANDA 3件(jian)。2020年(nian)中(zhong)药各类注册申请的审(shen)评完(wan)(wan)(wan)成情况详见(jian)图3。

 

2.审评通过情况

药(yao)审(shen)(shen)中(zhong)心审(shen)(shen)评(ping)通过(guo)批准中(zhong)药(yao)IND申请(qing)28件,审(shen)(shen)评(ping)通过(guo)中(zhong)药(yao)NDA 4件(连花清咳片(pian)、筋(jin)骨(gu)止痛凝胶(jiao)、桑(sang)(sang)枝(zhi)总(zong)生(sheng)物碱片(pian)及桑(sang)(sang)枝(zhi)总(zong)生(sheng)物碱)。2020年中(zhong)药(yao)各类注册申请(qing)审(shen)(shen)评(ping)完(wan)成(cheng)的具体情况详(xiang)见表2,2016-2020年审(shen)(shen)评(ping)通过(guo)批准中(zhong)药(yao)IND申请(qing)和审(shen)(shen)评(ping)通过(guo)中(zhong)药(yao)NDA情况详(xiang)见图4。

 

 

  药(yao)(yao)(yao)审中心审评通过批准的(de)中药(yao)(yao)(yao)IND申请28件(jian),涉及10个适应症(zheng)领域(yu)。其(qi)中,呼吸7件(jian)、骨科4件(jian)、消化4件(jian),共占53.57%,2020年审评通过批准的(de)中药(yao)(yao)(yao)IND申请适应症(zheng)分布详见(jian)图(tu)5。

 

(三)化(hua)学药(yao)注册申请审评完成情况

1.总体情况

2020年(nian)(nian),药审中心完(wan)成(cheng)审评(ping)的化(hua)(hua)学(xue)(xue)药注册(ce)申(shen)请(qing)6778件。其中,完(wan)成(cheng)化(hua)(hua)学(xue)(xue)药临床(chuang)申(shen)请(qing)(IND申(shen)请(qing)和验证性临床(chuang))共1086件,较2019年(nian)(nian)增(zeng)长45.58%;完(wan)成(cheng)化(hua)(hua)学(xue)(xue)药NDA 163件;完(wan)成(cheng)化(hua)(hua)学(xue)(xue)药ANDA 1697件;完(wan)成(cheng)一致性评(ping)价申(shen)请(qing)1136件,较2019年(nian)(nian)增(zeng)长103.22%;完(wan)成(cheng)化(hua)(hua)学(xue)(xue)药补充申(shen)请(qing)2248件,较2019年(nian)(nian)增(zeng)长23.72%。2020年(nian)(nian)化(hua)(hua)学(xue)(xue)药各类注册(ce)申(shen)请(qing)的审评(ping)完(wan)成(cheng)情况详(xiang)见图6。

 

2.审评通过情况

药审中心完成审评的化学(xue)药注册申(shen)请中,审评通(tong)过(guo)批(pi)准(zhun)IND申(shen)请907件(jian)(jian),较(jiao)2019年增(zeng)长51.42%;审评通(tong)过(guo)NDA 115件(jian)(jian),较(jiao)2019年增(zeng)长30.68%;审评通(tong)过(guo)ANDA 918件(jian)(jian),较(jiao)2019年增(zeng)长15.33%。2020年化学(xue)药各类注册申(shen)请审评完成的具(ju)体情况详见表3。

 

药审(shen)中(zhong)心完成审(shen)评(ping)的化学药IND申(shen)请(qing)960件,审(shen)评(ping)通(tong)过批准(zhun)IND申(shen)请(qing)907件。其(qi)中(zhong),1类(lei)创新化学药IND申(shen)请(qing)694件(298个品种),较2019年增长40.77%,品种数较2019年增长57.67%。2016-2020年审(shen)评(ping)通(tong)过批准(zhun)化学药IND申(shen)请(qing)、1类(lei)创新化学药IND申(shen)请(qing)情(qing)况详见图7。

 

药(yao)(yao)(yao)审(shen)(shen)中心审(shen)(shen)评通(tong)过(guo)批(pi)(pi)准IND申请的694件(jian)1类(lei)创新(xin)化(hua)(hua)学药(yao)(yao)(yao)中,抗肿瘤药(yao)(yao)(yao)物(wu)(wu)、抗感染药(yao)(yao)(yao)物(wu)(wu)、循环系统(tong)疾病(bing)药(yao)(yao)(yao)物(wu)(wu)、内分(fen)泌系统(tong)药(yao)(yao)(yao)物(wu)(wu)、消化(hua)(hua)系统(tong)疾病(bing)药(yao)(yao)(yao)物(wu)(wu)和风(feng)湿性疾病(bing)及免疫药(yao)(yao)(yao)物(wu)(wu)较(jiao)多,占全(quan)部创新(xin)药(yao)(yao)(yao)临床(chuang)试验批(pi)(pi)准数量的80.69%。2020年审(shen)(shen)评通(tong)过(guo)批(pi)(pi)准的1类(lei)创新(xin)化(hua)(hua)学药(yao)(yao)(yao)IND申请适应(ying)症分(fen)布详见(jian)图8。

 

药(yao)(yao)审(shen)中心完成审(shen)评(ping)的化学药(yao)(yao)NDA共163件。其(qi)中,审(shen)评(ping)通过化药(yao)(yao)NDA 115件,审(shen)评(ping)通过1类创新化学药(yao)(yao)NDA 14个品种。2016-2020年审(shen)评(ping)通过化学药(yao)(yao)NDA情况(kuang)详见图9。

 

  药(yao)审(shen)中(zhong)心完成审(shen)评(ping)(ping)的一(yi)(yi)致性评(ping)(ping)价(jia)申(shen)请共1136件,审(shen)评(ping)(ping)通(tong)过(guo)(guo)(guo)577件。其中(zhong),审(shen)评(ping)(ping)通(tong)过(guo)(guo)(guo)批准(zhun)口(kou)服固体制剂一(yi)(yi)致性评(ping)(ping)价(jia)456件,审(shen)评(ping)(ping)通(tong)过(guo)(guo)(guo)批准(zhun)注射剂一(yi)(yi)致性评(ping)(ping)价(jia)申(shen)请121件,具体品(pin)种(zhong)详见附(fu)件3。2018-2020年(nian)审(shen)评(ping)(ping)通(tong)过(guo)(guo)(guo)批准(zhun)的一(yi)(yi)致性评(ping)(ping)价(jia)申(shen)请情况(kuang)详见图10。

 

(四(si))生物制品注册申请(qing)审评完成情况

1.总体情况

2020年,药审中心完成(cheng)审评的(de)生物(wu)制(zhi)品(pin)(pin)注册申(shen)请(qing)共1410件(jian)(jian)。其中,完成(cheng)预防用(yong)(yong)(yong)生物(wu)制(zhi)品(pin)(pin)IND申(shen)请(qing)(预防用(yong)(yong)(yong)IND申(shen)请(qing))27件(jian)(jian),完成(cheng)治疗(liao)用(yong)(yong)(yong)生物(wu)制(zhi)品(pin)(pin)IND申(shen)请(qing)(治疗(liao)用(yong)(yong)(yong)IND申(shen)请(qing))537件(jian)(jian),较2019年增长(zhang)58.88%;完成(cheng)预防用(yong)(yong)(yong)生物(wu)制(zhi)品(pin)(pin)NDA(预防用(yong)(yong)(yong)NDA)9件(jian)(jian),完成(cheng)治疗(liao)用(yong)(yong)(yong)生物(wu)制(zhi)品(pin)(pin)NDA(治疗(liao)用(yong)(yong)(yong)NDA)108件(jian)(jian),完成(cheng)体(ti)外(wai)诊断试(shi)剂NDA(体(ti)外(wai)诊断NDA)1件(jian)(jian)。2020年生物(wu)制(zhi)品(pin)(pin)各(ge)类注册申(shen)请(qing)的(de)审评完成(cheng)情况详见图11。

 

2.审(shen)评通过情(qing)况

药审(shen)(shen)中心审(shen)(shen)评(ping)(ping)通(tong)过(guo)批(pi)准(zhun)生(sheng)物制品IND申请(qing)(qing)(qing)(qing)500件(jian)(jian),较(jiao)(jiao)2019年增长60.26%。其中,预防用(yong)IND申请(qing)(qing)(qing)(qing)19件(jian)(jian);治(zhi)疗(liao)用(yong)IND申请(qing)(qing)(qing)(qing)481件(jian)(jian),较(jiao)(jiao)2019年增长63.61%。审(shen)(shen)评(ping)(ping)通(tong)过(guo)生(sheng)物制品NDA 89件(jian)(jian),较(jiao)(jiao)2019年增长20.27%。其中,预防用(yong)NDA 7件(jian)(jian);治(zhi)疗(liao)用(yong)NDA 81件(jian)(jian)(制剂77件(jian)(jian)),较(jiao)(jiao)2019年增长19.12%;体外(wai)诊断NDA 1件(jian)(jian)。2020年生(sheng)物制品各类注册申请(qing)(qing)(qing)(qing)审(shen)(shen)评(ping)(ping)完(wan)成的具体情况详(xiang)见(jian)(jian)表(biao)4,2016-2020年审(shen)(shen)评(ping)(ping)通(tong)过(guo)批(pi)准(zhun)生(sheng)物制品IND申请(qing)(qing)(qing)(qing)和审(shen)(shen)评(ping)(ping)通(tong)过(guo)NDA情况详(xiang)见(jian)(jian)图12。

 

 

药(yao)审(shen)中(zhong)心(xin)(xin)审(shen)评通过批准生(sheng)物(wu)制品(pin)(pin)IND申请500件,2020年审(shen)评通过批准的生(sheng)物(wu)制品(pin)(pin)IND申请适(shi)应症(zheng)分(fen)布详见图13。药(yao)审(shen)中(zhong)心(xin)(xin)审(shen)评通过生(sheng)物(wu)制品(pin)(pin)NDA 89件,2020年审(shen)评通过的生(sheng)物(wu)制品(pin)(pin)NDA适(shi)应症(zheng)分(fen)布详见图14。

 

 

(五)行(xing)政审批注册申请完成情况

1.总体情况

2020年(nian),药审(shen)(shen)中心完成中药、化学药、生物(wu)(wu)制品(pin)各(ge)类注(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)行(xing)政(zheng)审(shen)(shen)批(pi)共8646件,较(jiao)(jiao)2019年(nian)增(zeng)长44.51%。其中,完成审(shen)(shen)评(ping)审(shen)(shen)批(pi)的(de)注(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)(临床(chuang)试验申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)、一致性评(ping)价申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)、补(bu)充申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)、境外生产药品(pin)再注(zhu)册(ce)(ce)(ce)(ce)及复(fu)审(shen)(shen))5674件,较(jiao)(jiao)2019年(nian)增(zeng)长39.24%;完成直接行(xing)政(zheng)审(shen)(shen)批(pi)的(de)注(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)(无需技术审(shen)(shen)评(ping)的(de)补(bu)充申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)、临时进(jin)口申(shen)(shen)(shen)(shen)(shen)请(qing)(qing))2972件,较(jiao)(jiao)2019年(nian)增(zeng)长55.77%。2020年(nian)中药、化学药、生物(wu)(wu)制品(pin)各(ge)类注(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)行(xing)政(zheng)审(shen)(shen)批(pi)完成情况(kuang)见表5。2018-2020年(nian)行(xing)政(zheng)审(shen)(shen)批(pi)注(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)(shen)(shen)(shen)请(qing)(qing)完成情况(kuang)详见图(tu)15。

 

 

2.需审评审批的注册申请完成情况

药(yao)审中(zhong)心完成的需审评(ping)审批(pi)的5674件(jian)注(zhu)册申请中(zhong),临床试验申请1686件(jian)(含验证性(xing)临床),较(jiao)2019年增长(zhang)50.00%;一致(zhi)性(xing)评(ping)价(jia)申请623件(jian),较(jiao)2019年增长(zhang)80.58%;补充申请2860件(jian),较(jiao)2019年增长(zhang)34.46%;境外生产药(yao)品再注(zhu)册478件(jian)、复审27件(jian)。

3.直接行(xing)政审批的注册申(shen)请完成情(qing)况(kuang)

药审中(zhong)心完成直接行政审批的2972件(jian)注册(ce)(ce)申(shen)请(qing)(qing)中(zhong),按注册(ce)(ce)申(shen)请(qing)(qing)类(lei)型划分,补(bu)充申(shen)请(qing)(qing)2537件(jian)、临时进(jin)口(kou)申(shen)请(qing)(qing)435件(jian)。按药品类(lei)型划分,中(zhong)药153件(jian)、化学(xue)药2411件(jian)、生物制品408件(jian)。

(六)注册申请(qing)不批准的(de)主要原因及存在的(de)问题

2020年,中药(yao)(yao)、化学药(yao)(yao)、生物制品(pin)各类药(yao)(yao)品(pin)注(zhu)册(ce)申(shen)请因申(shen)报(bao)资料(liao)无法(fa)证明(ming)药(yao)(yao)品(pin)安全(quan)性、有效性或者质量可控(kong)性,以及未能按(an)期提交补充资料(liao)等(deng)情形,导致审评结论为建议(yi)不(bu)批(pi)准(zhun)的(de)(de)共367件。通(tong)过系统梳理(li)上述注(zhu)册(ce)申(shen)请不(bu)批(pi)准(zhun)原因,从(cong)新药(yao)(yao)、仿(fang)制药(yao)(yao)等(deng)不(bu)同注(zhu)册(ce)分(fen)类角度分(fen)析药(yao)(yao)品(pin)注(zhu)册(ce)申(shen)请在研发和申(shen)报(bao)过程中存在的(de)(de)主要问题包括:

1.新药申(shen)请(qing)

IND申(shen)(shen)请和研发(fa)中存在的(de)(de)问题主(zhu)要(yao)(yao)有:正式申(shen)(shen)报前未(wei)开(kai)(kai)展沟(gou)通交流;开(kai)(kai)发(fa)立题依据不(bu)(bu)足(zu),成药(yao)(yao)性存在严(yan)重(zhong)缺陷;申(shen)(shen)报资(zi)料不(bu)(bu)足(zu)以支(zhi)持(chi)开(kai)(kai)展药(yao)(yao)物临(lin)(lin)床(chuang)试验或者不(bu)(bu)能保障临(lin)(lin)床(chuang)受试者安全。具体表现包(bao)括:未(wei)沟(gou)通交流致使申(shen)(shen)报后发(fa)现研究(jiu)(jiu)信息严(yan)重(zhong)缺项,无法在时限内完成补充研究(jiu)(jiu);已有的(de)(de)研究(jiu)(jiu)结果(guo)提(ti)示药(yao)(yao)效作用弱,毒性大,临(lin)(lin)床(chuang)获益和风险(xian)比值不(bu)(bu)合(he)(he)(he)(he)理;临(lin)(lin)床(chuang)开(kai)(kai)发(fa)定位违背临(lin)(lin)床(chuang)诊疗、用药(yao)(yao)的(de)(de)基(ji)本原则;已有的(de)(de)药(yao)(yao)学、临(lin)(lin)床(chuang)前研究(jiu)(jiu)不(bu)(bu)符合(he)(he)(he)(he)临(lin)(lin)床(chuang)试验要(yao)(yao)求;临(lin)(lin)床(chuang)试验方案整体设(she)计严(yan)重(zhong)缺陷,风险(xian)控(kong)制(zhi)措施不(bu)(bu)足(zu);联合(he)(he)(he)(he)用药(yao)(yao)的(de)(de)非(fei)临(lin)(lin)床(chuang)研究(jiu)(jiu)数据不(bu)(bu)充分;联合(he)(he)(he)(he)疫(yi)苗(miao)中单苗(miao)的(de)(de)数据不(bu)(bu)充分和/或免疫(yi)程序不(bu)(bu)一致。

NDA研(yan)(yan)发(fa)和申报中存在的(de)问(wen)题主要(yao)有(you)(you):研(yan)(yan)究(jiu)(jiu)质(zhi)量(liang)控制和管理存在缺陷(xian)(xian),导(dao)致已有(you)(you)的(de)研(yan)(yan)究(jiu)(jiu)结(jie)果不能证(zheng)明(ming)药(yao)品安全性(xing)、有(you)(you)效性(xing)和质(zhi)量(liang)可控性(xing);违反合规性(xing)要(yao)求。具(ju)体(ti)表现包括:关键临(lin)床研(yan)(yan)究(jiu)(jiu)设计存在重大缺陷(xian)(xian),无法(fa)得出客(ke)观、有(you)(you)力的(de)有(you)(you)效性(xing)、安全性(xing)证(zheng)据(ju)(ju);药(yao)学研(yan)(yan)究(jiu)(jiu)存在严重缺陷(xian)(xian),无法(fa)证(zheng)明(ming)产(chan)品的(de)质(zhi)量(liang)可控性(xing);各开发(fa)阶段(duan)的(de)研(yan)(yan)究(jiu)(jiu)受试样(yang)品不一(yi)致;注册核(he)查(cha)中发(fa)现临(lin)床试验数据(ju)(ju)存在真实性(xing)问(wen)题。

2.仿制药(yao)申请

仿制(zhi)药(yao)一致性评价申(shen)请(qing)和上市申(shen)请(qing)中(zhong)存在的(de)问题主要有(you)(you):仿制(zhi)药(yao)研发立(li)题不合(he)(he)理(li);申(shen)报资料无法(fa)(fa)证明仿制(zhi)药(yao)与参(can)比制(zhi)剂(被仿制(zhi)药(yao)品(pin))的(de)质量(liang)一致性。具(ju)体表现包括:仿制(zhi)药(yao)的(de)参(can)比制(zhi)剂已撤市,且已有(you)(you)更新换代安全性更好的(de)产品(pin)满足临床(chuang)需求;样品(pin)复核(he)检验(yan)不符合(he)(he)规定或分析方法(fa)(fa)存在严重缺陷;人(ren)体生物(wu)等(deng)效性试验(yan)结果(guo)表明不等(deng)效;样品(pin)稳定性研究结果(guo)、原(yuan)料药(yao)起(qi)始物(wu)料选(xuan)择等(deng)不符合(he)(he)仿制(zhi)药(yao)上市技术(shu)要求;仿制(zhi)药(yao)未(wei)按规定使用具(ju)有(you)(you)合(he)(he)法(fa)(fa)来源的(de)原(yuan)料药(yao)。

3.补充申请

补(bu)充(chong)申(shen)请研究和(he)申(shen)报(bao)中(zhong)存(cun)在(zai)的(de)问题主要(yao)有:申(shen)请资料未(wei)能充(chong)分说明变(bian)更(geng)(geng)(geng)的(de)科学性(xing)(xing)(xing)和(he)合理性(xing)(xing)(xing),不足以支持变(bian)更(geng)(geng)(geng)事项;已(yi)有的(de)研究结果(guo)不能保证变(bian)更(geng)(geng)(geng)后(hou)产品(pin)的(de)安(an)全(quan)性(xing)(xing)(xing)、有效性(xing)(xing)(xing)和(he)质量可控性(xing)(xing)(xing)。具体(ti)表现包括:变(bian)更(geng)(geng)(geng)引起药用(yong)物(wu)质基础发生重大改变(bian);药品(pin)说明书(shu)修改申(shen)请不符合说明书(shu)撰写的(de)技(ji)术(shu)要(yao)求;用(yong)于支持变(bian)更(geng)(geng)(geng)的(de)文献(xian)资料存(cun)在(zai)偏倚,或者临床安(an)全(quan)性(xing)(xing)(xing)和(he)有效性(xing)(xing)(xing)数据不充(chong)分。

4.其他

其(qi)他药(yao)(yao)品注(zhu)册申(shen)请在研发(fa)和申(shen)报中存(cun)在的问题主要有:生物(wu)(wu)类(lei)似(si)药(yao)(yao)开发(fa)缺少相似(si)性比较数(shu)据,药(yao)(yao)学比对研究中参照药(yao)(yao)选择存(cun)在缺陷;生物(wu)(wu)类(lei)似(si)药(yao)(yao)临床前研究结(jie)果不足以支持其(qi)开展临床试验;天然药(yao)(yao)物(wu)(wu)的研究资料不符合国(guo)际(ji)多中心临床试验或我(wo)国(guo)天然药(yao)(yao)物(wu)(wu)评(ping)价基本技术要求。

(七)药品加快(kuai)上(shang)市注册程序情况(kuang)

创新是推动(dong)药(yao)品高质量发(fa)展的力量源泉,《药(yao)品注册管理办(ban)法(fa)》结合(he)我国(guo)医(yi)药(yao)产业发(fa)展和临床需(xu)求实际(ji),参考国(guo)际(ji)经验(yan),设立了特(te)别审(shen)批(pi)(pi)、突破性治疗(liao)药(yao)物(wu)(wu)(wu)、附条件(jian)批(pi)(pi)准(zhun)、优先审(shen)评审(shen)批(pi)(pi)四个(ge)(ge)药(yao)品加(jia)(jia)快(kuai)(kuai)(kuai)上(shang)市程(cheng)序(xu)(xu)。《国(guo)家药(yao)监局关(guan)于发(fa)布(bu)<突破性治疗(liao)药(yao)物(wu)(wu)(wu)审(shen)评工(gong)作程(cheng)序(xu)(xu)(试行)>等(deng)三个(ge)(ge)文(wen)件(jian)的公告(gao)》(2020年第82号(hao)),明确了加(jia)(jia)快(kuai)(kuai)(kuai)通道的适(shi)用(yong)(yong)(yong)范(fan)围、适(shi)用(yong)(yong)(yong)条件(jian)、工(gong)作程(cheng)序(xu)(xu)和政策支持等(deng),既能显著提高相关(guan)程(cheng)序(xu)(xu)执(zhi)行过(guo)程(cheng)中的可(ke)操作性,鼓励(li)药(yao)物(wu)(wu)(wu)研制和创新,又能在全球抗(kang)击疫情的大背(bei)景下,依法(fa)依规对(dui)疫情防控所需(xu)药(yao)物(wu)(wu)(wu)实行特(te)别审(shen)批(pi)(pi),对(dui)于加(jia)(jia)快(kuai)(kuai)(kuai)临床急需(xu)、临床价(jia)值突出、公共卫(wei)生(sheng)急需(xu)等(deng)药(yao)物(wu)(wu)(wu)的上(shang)市具有重要(yao)推动(dong)作用(yong)(yong)(yong)。2020年已批(pi)(pi)准(zhun)上(shang)市药(yao)品纳入加(jia)(jia)快(kuai)(kuai)(kuai)上(shang)市程(cheng)序(xu)(xu)情况(kuang)详(xiang)见附件(jian)4。

1.特别审批药物情(qing)况

在(zai)发(fa)生(sheng)突发(fa)公(gong)共卫生(sheng)事(shi)件(jian)的(de)威胁(xie)时以及(ji)突发(fa)公(gong)共卫生(sheng)事(shi)件(jian)发(fa)生(sheng)后,国(guo)家(jia)药(yao)监局可依法决定(ding)(ding)对突发(fa)公(gong)共卫生(sheng)事(shi)件(jian)应急所需防(fang)治(zhi)药(yao)品(pin)实行特(te)别(bie)审(shen)(shen)批(pi)。纳入实施特(te)别(bie)审(shen)(shen)批(pi)程序(xu)的(de)药(yao)物(wu),国(guo)家(jia)药(yao)监局按照统一指挥、早期介入、快(kuai)速(su)高效、科学审(shen)(shen)批(pi)的(de)原则,组织加快(kuai)并同步开(kai)展药(yao)品(pin)注(zhu)册受理(li)、审(shen)(shen)评、核查、检验工作,并根据疾病防(fang)控(kong)的(de)特(te)定(ding)(ding)需要,限(xian)定(ding)(ding)其在(zai)一定(ding)(ding)的(de)期限(xian)和范围内使用。

2020年新(xin)(xin)冠(guan)(guan)肺(fei)炎(yan)疫(yi)情在全球范围内不断蔓(man)延,人民群(qun)众的(de)生(sheng)命(ming)安(an)全受(shou)到(dao)严重威胁,药(yao)审中(zhong)心闻(wen)令而(er)动,第一时间科学(xue)、高效推(tui)进特别(bie)审评工作,按程(cheng)序将59件(jian)(jian)(jian)中(zhong)药(yao)、化(hua)学(xue)药(yao)、生(sheng)物制品注册申请纳入(ru)特别(bie)审批(pi)程(cheng)序并完成技(ji)术审评。建议附(fu)条件(jian)(jian)(jian)批(pi)准上市1件(jian)(jian)(jian),为新(xin)(xin)型(xing)冠(guan)(guan)状病毒灭活(huo)疫(yi)苗(Vero细(xi)胞);建议批(pi)准临(lin)床试(shi)验(yan)(yan)申请53件(jian)(jian)(jian),其中(zhong)5件(jian)(jian)(jian)已(yi)进入(ru)Ⅲ期临(lin)床试(shi)验(yan)(yan),批(pi)准化(hua)湿败(bai)毒颗粒、清(qing)肺(fei)排(pai)毒颗粒的(de)临(lin)床试(shi)验(yan)(yan)申请;批(pi)准了连花清(qing)瘟胶囊/颗粒、金(jin)花清(qing)感颗粒及血必净注射(she)液(ye)等5件(jian)(jian)(jian)增加(jia)(jia)适应(ying)症的(de)补充申请,加(jia)(jia)速(su)了新(xin)(xin)冠(guan)(guan)病毒疫(yi)苗和(he)新(xin)(xin)冠(guan)(guan)肺(fei)炎(yan)治疗药(yao)物的(de)上市进程(cheng),初步满足(zu)了新(xin)(xin)冠(guan)(guan)肺(fei)炎(yan)疫(yi)情防控的(de)需要。

2.突(tu)破性治疗药(yao)物情(qing)况

突(tu)破(po)(po)性治(zhi)(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)(wu)指的是(shi)用(yong)于防(fang)治(zhi)(zhi)(zhi)严(yan)重危及生命或(huo)(huo)者严(yan)重影响生存(cun)质量的疾(ji)病,且尚无有(you)效防(fang)治(zhi)(zhi)(zhi)手段(duan)(duan)或(huo)(huo)者与(yu)现有(you)治(zhi)(zhi)(zhi)疗(liao)手段(duan)(duan)相(xiang)比有(you)足够证据(ju)表(biao)明具有(you)明显(xian)临床(chuang)(chuang)优(you)势的创新(xin)(xin)药(yao)(yao)(yao)或(huo)(huo)者改良型(xing)新(xin)(xin)药(yao)(yao)(yao)等,申请人可在Ⅰ、Ⅱ临床(chuang)(chuang)试验(yan)阶段(duan)(duan)申请适用(yong)突(tu)破(po)(po)性治(zhi)(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)(wu)程(cheng)序。根(gen)据(ju)《突(tu)破(po)(po)性治(zhi)(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)(wu)审评工(gong)作程(cheng)序(试行)》,纳入到(dao)“突(tu)破(po)(po)性治(zhi)(zhi)(zhi)疗(liao)”审评通(tong)道(dao)的药(yao)(yao)(yao)物(wu)(wu),药(yao)(yao)(yao)审中(zhong)心一是(shi)会优(you)先处理相(xiang)关沟通(tong)交流,加(jia)强指导并促(cu)进药(yao)(yao)(yao)物(wu)(wu)研发进程(cheng);二(er)是(shi)在申报上市环节(jie),该(gai)药(yao)(yao)(yao)物(wu)(wu)可适用(yong)优(you)先审评审批程(cheng)序,审评时(shi)限进一步缩短;三(san)是(shi)上市申请阶段(duan)(duan),药(yao)(yao)(yao)审中(zhong)心会滚(gun)动接(jie)收其申报资料(liao),并优(you)先安(an)排(pai)核查、检验(yan)等,可大(da)大(da)缩减(jian)新(xin)(xin)药(yao)(yao)(yao)从研发到(dao)上市的时(shi)间(jian)。2020年药(yao)(yao)(yao)审中(zhong)心收到(dao)147件(jian)(jian)(jian)突(tu)破(po)(po)性治(zhi)(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)(wu)申请。经(jing)综合(he)评估、公(gong)示,已将24件(jian)(jian)(jian)突(tu)破(po)(po)性治(zhi)(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)(wu)申请(21个品种)纳入突(tu)破(po)(po)性治(zhi)(zhi)(zhi)疗(liao)药(yao)(yao)(yao)物(wu)(wu)程(cheng)序,详(xiang)见附件(jian)(jian)(jian)5。

3.附条件批准(zhun)药物情况

附(fu)条(tiao)件批(pi)准(zhun)上市(shi)(shi),目的(de)在于(yu)缩短药(yao)物临(lin)床试验的(de)研发时间(jian),使(shi)其(qi)尽早(zao)应用于(yu)无(wu)法继续(xu)等(deng)待的(de)危重疾病(bing)或公(gong)共(gong)卫生方(fang)面(mian)急需的(de)患者(zhe)。药(yao)物有(you)效性(xing)评价(jia)的(de)指标(biao)为临(lin)床终(zhong)点(dian),符合附(fu)条(tiao)件批(pi)准(zhun)上市(shi)(shi)情形的(de)药(yao)物,可使(shi)用替(ti)代终(zhong)点(dian)、中间(jian)临(lin)床终(zhong)点(dian)或早(zao)期临(lin)床试验数据来反映(ying)药(yao)物的(de)有(you)效性(xing),当这(zhei)些数据能够提示药(yao)品的(de)获益(yi)大于(yu)风险(xian)时候,即可申(shen)请(qing)附(fu)条(tiao)件批(pi)准(zhun)上市(shi)(shi)。

对(dui)于(yu)若不尽早进(jin)行治疗则会在数月或者更短时间(jian)内导致死亡的(de)疾病(bing)患(huan)者来说,附(fu)条件批准上市的(de)药(yao)物,使得这些无法继续等待的(de)患(huan)者能够延(yan)续生(sheng)命、提高生(sheng)存质(zhi)量(liang),消除(chu)重(zhong)大突发公(gong)共卫生(sheng)事件对(dui)于(yu)人(ren)民(min)生(sheng)命安全(quan)的(de)威胁(xie)。2020年药(yao)审中心审评通过的(de)新(xin)药(yao)上市申(shen)请(qing)中,共有15件注册申(shen)请(qing)经附(fu)条件批准后上市,覆(fu)盖了新(xin)型冠状(zhuang)病(bing)毒感染引起的(de)疾病(bing)、非小细胞肺癌(ai)、卵巢癌(ai)等适应症。

4.优先审评药物情况

(1)优先审评品种纳入情况(kuang)

《药品(pin)(pin)注册管(guan)理办法》对优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)程(cheng)序的(de)(de)(de)(de)调整,是(shi)在多(duo)(duo)年实践经验(yan)基础上的(de)(de)(de)(de)优(you)化,一是(shi)适用范围更多(duo)(duo)地向(xiang)具有明显临(lin)(lin)床价(jia)值、临(lin)(lin)床急(ji)需(xu)(xu)和临(lin)(lin)床优(you)势的(de)(de)(de)(de)药物聚焦,致力(li)于将更多(duo)(duo)的(de)(de)(de)(de)临(lin)(lin)床价(jia)值显著、临(lin)(lin)床急(ji)需(xu)(xu)的(de)(de)(de)(de)短缺药品(pin)(pin)、防治(zhi)重大(da)传染病(bing)、罕(han)见病(bing)、儿童用药、纳入突(tu)破性治(zhi)疗程(cheng)序、符合附条(tiao)件批(pi)准(zhun)的(de)(de)(de)(de)药品(pin)(pin)等纳入优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)程(cheng)序;二是(shi)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)时(shi)限(xian)的(de)(de)(de)(de)加速,药品(pin)(pin)上市许可(ke)申请的(de)(de)(de)(de)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)时(shi)限(xian)一般为200个(ge)(ge)(ge)工作(zuo)日(ri),与完(wan)(wan)整的(de)(de)(de)(de)申报(bao)路径相比(bi),优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)程(cheng)序的(de)(de)(de)(de)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)时(shi)限(xian)缩短至130个(ge)(ge)(ge)工作(zuo)日(ri),其中(zhong)临(lin)(lin)床急(ji)需(xu)(xu)境外(wai)已上市罕(han)见病(bing)用药优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)程(cheng)序的(de)(de)(de)(de)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)时(shi)限(xian)为70个(ge)(ge)(ge)工作(zuo)日(ri)。药审(shen)(shen)(shen)(shen)中(zhong)心(xin)通过优(you)化审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)资源配置率,在高标准(zhun)完(wan)(wan)成技术审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)的(de)(de)(de)(de)前提下,力(li)争按(an)时(shi)限(xian)完(wan)(wan)成审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping),推动纳入优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)程(cheng)序中(zhong)的(de)(de)(de)(de)品(pin)(pin)种尽快获(huo)批(pi)上市。

根据(ju)《药(yao)(yao)(yao)品(pin)(pin)注册(ce)管(guan)理(li)办(ban)法(fa)》、46号公告、《国(guo)家(jia)食品(pin)(pin)药(yao)(yao)(yao)品(pin)(pin)监督管(guan)理(li)总(zong)局关于鼓励药(yao)(yao)(yao)品(pin)(pin)创新实行优(you)先审(shen)评(ping)(ping)审(shen)批的意见(jian)》(食药(yao)(yao)(yao)监药(yao)(yao)(yao)化管(guan)〔2017〕126号,以下简称126号文件(jian)(jian)),2020年药(yao)(yao)(yao)审(shen)中心(xin)将(jiang)219件(jian)(jian)(按(an)(an)通(tong)用(yong)名(ming)计127个品(pin)(pin)种)注册(ce)申(shen)请纳入(ru)(ru)优(you)先审(shen)评(ping)(ping)审(shen)批程(cheng)(cheng)序(xu)(xu)。其中,144件(jian)(jian)注册(ce)申(shen)请按(an)(an)照126号文件(jian)(jian)规定的范围纳入(ru)(ru)优(you)先审(shen)评(ping)(ping)审(shen)批程(cheng)(cheng)序(xu)(xu),75件(jian)(jian)按(an)(an)照《药(yao)(yao)(yao)品(pin)(pin)注册(ce)管(guan)理(li)办(ban)法(fa)》规定的范围纳入(ru)(ru)优(you)先审(shen)评(ping)(ping)审(shen)批程(cheng)(cheng)序(xu)(xu),包(bao)括42件(jian)(jian)儿童用(yong)药(yao)(yao)(yao)和罕见(jian)病用(yong)药(yao)(yao)(yao)。2016-2020年纳入(ru)(ru)优(you)先审(shen)评(ping)(ping)审(shen)批程(cheng)(cheng)序(xu)(xu)的各类(lei)注册(ce)申(shen)请情况详见(jian)表6和表7。

   

 

 

  按此前(qian)优先审评(ping)范围(wei)纳入的注册(ce)申请中,同步申报(bao)占比(bi)多达44%(64/144),具(ju)有(you)明显临床价值的新药占比(bi)为(wei)20%,按与原研药质量和疗效一(yi)致的标准完善后重(zhong)新申报(bao)品种占比(bi)则(ze)由7.9%降至4.2%。

按照《药(yao)品(pin)注册(ce)管(guan)理办法》优先审评范(fan)围纳入的(de)(de)注册(ce)申请中(zhong),符合附条件批准的(de)(de)药(yao)品(pin)占比为36%(27/75),创新药(yao)和儿(er)童用药(yao)占比28%(21/75),优先审评资源已向具有明显临床价值的(de)(de)创新、急(ji)需药(yao)物倾斜。

(2)优先审评品种完(wan)成情况

2020年有217件注(zhu)(zhu)册申请(按通(tong)用(yong)名计121个品(pin)种)通(tong)过优先审(shen)评程序建议批准上(shang)市(shi)(含已上(shang)市(shi)药(yao)品(pin)新增适应(ying)症),审(shen)评通(tong)过件数较2019年增长51.7%,例如:我(wo)国自(zi)主(zhu)研发的(de)(de)1类创新药(yao)甲磺酸阿(a)美替尼(ni)(ni)片(pian)、泽(ze)布(bu)替尼(ni)(ni)胶囊(nang)、奥(ao)布(bu)替尼(ni)(ni)片(pian)等,治疗(liao)罕见(jian)病法布(bu)雷病阿(a)加糖(tang)酶α注(zhu)(zhu)射用(yong)浓溶(rong)液(ye),用(yong)于配(pei)合饮食控制(zhi)及运动治疗(liao)2型糖(tang)尿病的(de)(de)中药(yao)新药(yao)桑枝总生物(wu)碱片(pian)、间(jian)变性淋(lin)巴瘤(liu)激酶抑制(zhi)剂盐酸恩沙(sha)替尼(ni)(ni)胶囊(nang)、成人复(fu)发型多发性硬化治疗(liao)药(yao)物(wu)西尼(ni)(ni)莫德片(pian)等。2016-2020年优先审(shen)评通(tong)过的(de)(de)品(pin)种情况详见(jian)表8。

 

(八)药品注(zhu)册(ce)现(xian)场核查相关(guan)情况

1.总(zong)体情况(kuang)

药(yao)审(shen)中(zhong)心积极落实《药(yao)品注(zhu)(zhu)(zhu)册(ce)管理办法》,转变药(yao)品注(zhu)(zhu)(zhu)册(ce)核查(cha)理念(nian),将注(zhu)(zhu)(zhu)册(ce)现场(chang)核查(cha)启动(dong)工作(zuo)模式由基于(yu)审(shen)评需要调整为基于(yu)风险启动(dong),并联开(kai)展(zhan)技术审(shen)评与(yu)注(zhu)(zhu)(zhu)册(ce)现场(chang)核查(cha)工作(zuo);对于(yu)自(zi)2020年7月1日(ri)起受(shou)理的注(zhu)(zhu)(zhu)册(ce)申请,在(zai)受(shou)理后40个工作(zuo)日(ri)内决定是(shi)否启动(dong)相应注(zhu)(zhu)(zhu)册(ce)现场(chang)核查(cha)任务。为便(bian)于(yu)申请人及时获知(zhi)注(zhu)(zhu)(zhu)册(ce)现场(chang)核查(cha)启动(dong)相关信息(xi),完善药(yao)审(shen)中(zhong)心网站申请人之窗栏目(mu),开(kai)通(tong)(tong)递交注(zhu)(zhu)(zhu)册(ce)现场(chang)核查(cha)用(yong)生产(chan)工艺与(yu)质量(liang)标准(zhun)通(tong)(tong)道和查(cha)收注(zhu)(zhu)(zhu)册(ce)现场(chang)核查(cha)电子通(tong)(tong)知(zhi)函(han)的功能(neng)。

2.注册现场核查具体情况

2020年,药审中心基(ji)于品(pin)种因(yin)素和研发生产(chan)主体合(he)规因(yin)素风险启动注册现(xian)场核(he)查(cha)(cha)任务(wu)1235个。其(qi)中,药学(xue)现(xian)场核(he)查(cha)(cha)任务(wu)792个,临(lin)床试(shi)验数据核(he)查(cha)(cha)任务(wu)439个,药理毒(du)理研究核(he)查(cha)(cha)任务(wu)4个。

药(yao)审中心接收(shou)核(he)查报告(gao)818份(fen)。其中,药(yao)学现(xian)场(chang)核(he)查报告(gao)449份(fen),临床试验(yan)核(he)查报告(gao)363份(fen),药(yao)理毒理研究核(he)查报告(gao)6份(fen)。

(九)沟通交流情况

1.总(zong)体情况

2020年,药(yao)审(shen)中(zhong)(zhong)心在(zai)落实疫(yi)情(qing)防控(kong)要(yao)求的(de)(de)同(tong)时,尽量满(man)足申(shen)请人的(de)(de)需要(yao),全力保障各类(lei)(lei)沟(gou)通(tong)(tong)交(jiao)流畅通(tong)(tong)。在(zai)推动(dong)新(xin)冠病(bing)毒(du)疫(yi)苗(miao)和新(xin)冠肺(fei)炎(yan)治疗药(yao)物的(de)(de)研发(fa)方(fang)(fang)面(mian),为79个新(xin)冠病(bing)毒(du)疫(yi)苗(miao),中(zhong)(zhong)医药(yao)、中(zhong)(zhong)和抗体(27个)等新(xin)冠肺(fei)炎(yan)治疗药(yao)物,组织申(shen)请人与药(yao)审(shen)中(zhong)(zhong)心审(shen)评(ping)团队之间的(de)(de)沟(gou)通(tong)(tong)交(jiao)流5600余(yu)次(ci),并(bing)针(zhen)对新(xin)冠病(bing)毒(du)疫(yi)苗(miao)、中(zhong)(zhong)和抗体等重点品种,单(dan)独设(she)立了(le)台账,动(dong)态跟(gen)进;在(zai)维(wei)护与申(shen)请人沟(gou)通(tong)(tong)桥梁方(fang)(fang)面(mian),药(yao)审(shen)中(zhong)(zhong)心发(fa)布了(le)《药(yao)物研发(fa)与技术审(shen)评(ping)沟(gou)通(tong)(tong)交(jiao)流管理办法(fa)》《药(yao)审(shen)中(zhong)(zhong)心关(guan)于业务咨(zi)(zi)询(xun)(xun)服(fu)务联络方(fang)(fang)式的(de)(de)通(tong)(tong)知》,优化了(le)电话咨(zi)(zi)询(xun)(xun)服(fu)务,每(mei)天有专人接(jie)听解答申(shen)请人咨(zi)(zi)询(xun)(xun)电话,根据咨(zi)(zi)询(xun)(xun)问题(ti)类(lei)(lei)型(xing)的(de)(de)不(bu)同(tong)设(she)立了(le)8个联系(xi)邮箱,及时解答处理申(shen)请人问题(ti),不(bu)断提高沟(gou)通(tong)(tong)交(jiao)流的(de)(de)质量和效率。

药审中心接收(shou)沟通交流会议申(shen)请3229件(jian),较2019年(nian)增长(zhang)22.64%,办理沟通交流会议申(shen)请2451件(jian),较2019年(nian)增长(zhang)31.00%。在(zai)网(wang)络平台接收(shou)一(yi)般(ban)(ban)性技术问(wen)题(ti)(ti)咨询20285个,较2019年(nian)增长(zhang)22.41%;接收(shou)电话(hua)咨询超过上万次,邮件(jian)咨询数千件(jian),同时也面向社会提供现场(chang)咨询服务。2016-2020年(nian)接收(shou)沟通交流申(shen)请和(he)一(yi)般(ban)(ban)性技术问(wen)题(ti)(ti)咨询具体情况详(xiang)见(jian)图(tu)16。

 

2.沟通交流会议(yi)申请的(de)完成(cheng)情况

药审中心所接收的3229件(jian)沟通(tong)交(jiao)(jiao)流会(hui)议(yi)申请中,符合会(hui)议(yi)召(zhao)开条件(jian)的,及时与申请人(ren)取(qu)得了联系,商议(yi)会(hui)议(yi)细节;无需召(zhao)开会(hui)议(yi)的,以(yi)书面形式尽快回复(fu)了申请人(ren)。2020年(nian)共办(ban)理了2451件(jian)沟通(tong)交(jiao)(jiao)流会(hui)议(yi)申请。在药物研发关键阶段召(zhao)开的Ⅱ类会(hui)议(yi)占比(bi)76.42%,其中临(lin)床前(qian)(Pre-IND)申请占比(bi)37.49%。2020年(nian)各类沟通(tong)交(jiao)(jiao)流会(hui)议(yi)申请及办(ban)理情况详(xiang)见表9。

 

  沟通(tong)(tong)交(jiao)流会(hui)议(yi)的形式为电(dian)话会(hui)议(yi)、视频会(hui)议(yi)、面(mian)对面(mian)会(hui)议(yi),共召开(kai)沟通(tong)(tong)交(jiao)流会(hui)议(yi)268次,以(yi)书面(mian)形式回复两千余件。2018-2020年各类沟通(tong)(tong)交(jiao)流会(hui)议(yi)的召开(kai)情况详见表(biao)10。

 

3.一般性技术(shu)问题答复情况

药审中心通过网上咨(zi)询平台共(gong)接(jie)收了(le)20285个(ge)(ge)一(yi)(yi)般(ban)性(xing)(xing)技术问(wen)(wen)题(ti)(ti)的咨(zi)询。按照(zhao)(zhao)内容(rong)分(fen)类(lei),问(wen)(wen)题(ti)(ti)主(zhu)要集(ji)中于受(shou)理(li)(4038个(ge)(ge))、原辅包(3952个(ge)(ge))等方面;按照(zhao)(zhao)药品分(fen)类(lei),问(wen)(wen)题(ti)(ti)主(zhu)要集(ji)中于化(hua)(hua)学(xue)药(11338个(ge)(ge))方面,其中化(hua)(hua)学(xue)药受(shou)理(li)(2396个(ge)(ge))、化(hua)(hua)学(xue)药一(yi)(yi)致(zhi)性(xing)(xing)评价(jia)(1258个(ge)(ge))。一(yi)(yi)般(ban)性(xing)(xing)技术问(wen)(wen)题(ti)(ti)答复具体情况详见表11。

 

二、药(yao)品(pin)注(zhu)册申请受理(li)情况

(一)总体情况

2020年(nian)(nian),根(gen)据46号公告、《国(guo)家(jia)药(yao)(yao)(yao)监(jian)局(ju)(ju)关(guan)于(yu)发布生(sheng)物(wu)制品注(zhu)(zhu)册分(fen)类(lei)及(ji)申(shen)(shen)(shen)报资料要求(qiu)(qiu)的(de)通告》(2020年(nian)(nian)第(di)43号)、《国(guo)家(jia)药(yao)(yao)(yao)监(jian)局(ju)(ju)关(guan)于(yu)发布化(hua)学药(yao)(yao)(yao)品注(zhu)(zhu)册分(fen)类(lei)及(ji)申(shen)(shen)(shen)报资料要求(qiu)(qiu)的(de)通告》(2020年(nian)(nian)第(di)44号)、《国(guo)家(jia)药(yao)(yao)(yao)监(jian)局(ju)(ju)关(guan)于(yu)发布<中(zhong)药(yao)(yao)(yao)注(zhu)(zhu)册分(fen)类(lei)及(ji)申(shen)(shen)(shen)报资料要求(qiu)(qiu)>的(de)通告》(2020年(nian)(nian)第(di)68号)等,药(yao)(yao)(yao)审(shen)(shen)中(zhong)心受理中(zhong)药(yao)(yao)(yao)、化(hua)学药(yao)(yao)(yao)、生(sheng)物(wu)制品各(ge)类(lei)注(zhu)(zhu)册申(shen)(shen)(shen)请共10245件(含药(yao)(yao)(yao)械组合产品6件),较(jiao)2019年(nian)(nian)增(zeng)长(zhang)26.76%。其中(zhong),需技(ji)(ji)术(shu)审(shen)(shen)评(ping)的(de)注(zhu)(zhu)册申(shen)(shen)(shen)请7147件(含5695件需药(yao)(yao)(yao)审(shen)(shen)中(zhong)心技(ji)(ji)术(shu)审(shen)(shen)评(ping)和行政审(shen)(shen)批的(de)注(zhu)(zhu)册申(shen)(shen)(shen)请),较(jiao)2019年(nian)(nian)增(zeng)长(zhang)15.29%;直接(jie)行政审(shen)(shen)批的(de)注(zhu)(zhu)册申(shen)(shen)(shen)请3092件,较(jiao)2019年(nian)(nian)增(zeng)长(zhang)64.64%。

受(shou)(shou)理(li)(li)的(de)10239件药(yao)品(pin)注(zhu)册(ce)申(shen)请(qing)(qing)中(zhong),化学(xue)药(yao)注(zhu)册(ce)申(shen)请(qing)(qing)受(shou)(shou)理(li)(li)量为7901件,较2019年增长22.02%,占2020年全(quan)部注(zhu)册(ce)申(shen)请(qing)(qing)受(shou)(shou)理(li)(li)量的(de)77.17%,2016-2020年各类药(yao)品(pin)注(zhu)册(ce)申(shen)请(qing)(qing)受(shou)(shou)理(li)(li)情况(kuang)详见图17。

 

2.药审(shen)中(zhong)心的直接行政审(shen)批工作自2017年开始,故2016年无直接行政审(shen)批注册(ce)申(shen)(shen)请,所有受理注册(ce)申(shen)(shen)请均需技术审(shen)评。

2020年(nian)受理的(de)(de)需技(ji)术(shu)审(shen)评(ping)的(de)(de)注(zhu)(zhu)册申请(qing)(qing)(qing)7147件(jian)中,化学药(yao)注(zhu)(zhu)册申请(qing)(qing)(qing)为5402件(jian),较(jiao)2019年(nian)增(zeng)长(zhang)9.42%,占全部需技(ji)术(shu)审(shen)评(ping)的(de)(de)注(zhu)(zhu)册申请(qing)(qing)(qing)受理量的(de)(de)75.58%;中药(yao)注(zhu)(zhu)册申请(qing)(qing)(qing)315件(jian),较(jiao)2019年(nian)增(zeng)长(zhang)22.57%;生(sheng)物制品注(zhu)(zhu)册申请(qing)(qing)(qing)1430件(jian),较(jiao)2019年(nian)增(zeng)长(zhang)42.29%。2016-2020年(nian)需技(ji)术(shu)审(shen)评(ping)的(de)(de)中药(yao)、化学药(yao)、生(sheng)物制品各类注(zhu)(zhu)册申请(qing)(qing)(qing)受理情况(kuang)详见图18。

 

(二(er))1类(lei)创新药受(shou)理情(qing)况(kuang)

2020年,药(yao)(yao)审(shen)中(zhong)(zhong)心受(shou)理(li)1类(lei)创新药(yao)(yao)注册(ce)申请共1062件(597个品(pin)(pin)种(zhong)),较(jiao)2019年增长51.71%。其中(zhong)(zhong),受(shou)理(li)IND申请1008件(559个品(pin)(pin)种(zhong)),较(jiao)2019年增长49.78%;受(shou)理(li)NDA 54件(38个品(pin)(pin)种(zhong)),较(jiao)2019年增长100.00%。以(yi)药(yao)(yao)品(pin)(pin)类(lei)别统(tong)(tong)计,中(zhong)(zhong)药(yao)(yao)、化学药(yao)(yao)、生物制品(pin)(pin)1类(lei)创新药(yao)(yao)受(shou)理(li)量分别为14、752、296件。以(yi)生产场地统(tong)(tong)计,境内生产药(yao)(yao)品(pin)(pin)843件,境外生产药(yao)(yao)品(pin)(pin)219件。详见表12和13。

 

(三)各(ge)类注册申请受理情况

1.中药注(zhu)册申请受理(li)情(qing)况

2020年(nian),药(yao)审中(zhong)(zhong)(zhong)(zhong)心受(shou)理(li)中(zhong)(zhong)(zhong)(zhong)药(yao)注(zhu)册(ce)申请471件(jian)。其中(zhong)(zhong)(zhong)(zhong),受(shou)理(li)中(zhong)(zhong)(zhong)(zhong)药(yao)IND申请22件(jian),受(shou)理(li)中(zhong)(zhong)(zhong)(zhong)药(yao)NDA 6件(jian),受(shou)理(li)中(zhong)(zhong)(zhong)(zhong)药(yao)ANDA 1件(jian)。2020年(nian)中(zhong)(zhong)(zhong)(zhong)药(yao)各类(lei)注(zhu)册(ce)申请受(shou)理(li)情况详见图19。

 

  受理(li)1类中(zhong)药(yao)创新药(yao)注(zhu)册(ce)申请14件(jian)(jian)。其(qi)中(zhong),受理(li)IND 申请9件(jian)(jian)(9个品种),受理(li)NDA 5件(jian)(jian)(5个品种)。

2.化学药注(zhu)册申请(qing)受理情(qing)况

2020年(nian),药审中(zhong)(zhong)心受(shou)(shou)理(li)化(hua)(hua)学(xue)药注(zhu)册(ce)申(shen)请(qing)(qing)(qing)7901。其中(zhong)(zhong),受(shou)(shou)理(li)化(hua)(hua)学(xue)药IND申(shen)请(qing)(qing)(qing)946件(jian),较(jiao)2019年(nian)增长36.31%;受(shou)(shou)理(li)化(hua)(hua)学(xue)药NDA 191件(jian),较(jiao)2019年(nian)增长46.92%;受(shou)(shou)理(li)ANDA 1125件(jian),较(jiao)2019年(nian)增长7.45%;受(shou)(shou)理(li)一致(zhi)性评价申(shen)请(qing)(qing)(qing)914件(jian),较(jiao)2019年(nian)减少11.95%。2020年(nian)化(hua)(hua)学(xue)药各类注(zhu)册(ce)申(shen)请(qing)(qing)(qing)受(shou)(shou)理(li)情况(kuang)详见图20。2016-2020年(nian)化(hua)(hua)学(xue)药各类注(zhu)册(ce)申(shen)请(qing)(qing)(qing)受(shou)(shou)理(li)情况(kuang)详见图21。

 

 

药(yao)审中心受(shou)理(li)(li)1类创新化学药(yao)注(zhu)册(ce)申请752件(jian)(360个(ge)品(pin)种(zhong)),较(jiao)2019年(nian)(nian)增(zeng)长31.24%。其(qi)中,受(shou)理(li)(li)IND申请721件(jian)(339个(ge)品(pin)种(zhong)),较(jiao)2019年(nian)(nian)增(zeng)长30.62%;受(shou)理(li)(li)NDA 31件(jian)(21个(ge)品(pin)种(zhong)),较(jiao)2019年(nian)(nian)增(zeng)长47.62%。

药审中心受(shou)(shou)理(li)化学药5.1类注册申(shen)(shen)请160件(jian)(jian),较2019年增长1.91%。其中受(shou)(shou)理(li)临(lin)床试验申(shen)(shen)请(验证(zheng)性临(lin)床)53件(jian)(jian),受(shou)(shou)理(li)NDA 107件(jian)(jian)。

360个品种的(de)1类创新(xin)(xin)化(hua)学(xue)(xue)药注(zhu)册(ce)申(shen)(shen)请(qing)中,境内生产化(hua)学(xue)(xue)药注(zhu)册(ce)申(shen)(shen)请(qing)为(wei)258个品种,境外(wai)生产化(hua)学(xue)(xue)药注(zhu)册(ce)申(shen)(shen)请(qing)为(wei)102个品种。2016-2020年1类创新(xin)(xin)化(hua)学(xue)(xue)药注(zhu)册(ce)申(shen)(shen)请(qing)受理情况详见图(tu)22。

 

3.生物制品注册(ce)申(shen)请受(shou)理情(qing)况(kuang)

2020年(nian)(nian),药审中心受(shou)理(li)(li)生物制(zhi)品注册(ce)申请(qing)1867件(jian)(jian)(jian)(jian)(jian)。其中,受(shou)理(li)(li)生物制(zhi)品IND申请(qing)580件(jian)(jian)(jian)(jian)(jian)(预防(fang)用(yong)IND申请(qing)25件(jian)(jian)(jian)(jian)(jian),治疗(liao)(liao)用(yong)IND申请(qing)555件(jian)(jian)(jian)(jian)(jian)),较2019年(nian)(nian)增(zeng)长87.10%;受(shou)理(li)(li)生物制(zhi)品NDA 126件(jian)(jian)(jian)(jian)(jian)(预防(fang)用(yong)NDA 7件(jian)(jian)(jian)(jian)(jian),治疗(liao)(liao)用(yong)NDA 117件(jian)(jian)(jian)(jian)(jian),体外诊断(duan)试剂2件(jian)(jian)(jian)(jian)(jian)),较2019年(nian)(nian)增(zeng)长1.62%。2020年(nian)(nian)生物制(zhi)品各类注册(ce)申请(qing)受(shou)理(li)(li)情(qing)况详见(jian)图(tu)23。2016-2020年(nian)(nian)生物制(zhi)品IND申请(qing)和NDA受(shou)理(li)(li)情(qing)况详见(jian)图(tu)24。

 

 

 

药审中心受(shou)理(li)1类(lei)创新生(sheng)(sheng)物制品注册(ce)申请296件(jian)(223个品种),较2019年(nian)增(zeng)长(zhang)(zhang)133.07%。其中,受(shou)理(li)预防用生(sheng)(sheng)物制品5件(jian),受(shou)理(li)治疗(liao)用生(sheng)(sheng)物制品291件(jian);受(shou)理(li)生(sheng)(sheng)物制品IND申请278件(jian)(211个品种),较2019年(nian)增(zeng)长(zhang)(zhang)129.75%;受(shou)理(li)生(sheng)(sheng)物制品NDA 18件(jian)(12个品种),较2019年(nian)增(zeng)长(zhang)(zhang)200.00%,具体情况详(xiang)见表14。

 

4.行政审(shen)批注册申请受理情况

(1)总体(ti)情况

2020年(nian),药(yao)审中(zhong)心受(shou)(shou)理(li)需(xu)中(zhong)心行政审批的(de)中(zhong)药(yao)、化学药(yao)、生物制品各(ge)类(lei)注(zhu)(zhu)册(ce)申(shen)(shen)请(qing)(qing)8787件,较(jiao)2019年(nian)增长29.51%。其中(zhong),受(shou)(shou)理(li)需(xu)审评(ping)审批的(de)注(zhu)(zhu)册(ce)申(shen)(shen)请(qing)(qing)(临床(chuang)试验申(shen)(shen)请(qing)(qing)、一致性评(ping)价(jia)申(shen)(shen)请(qing)(qing)、补充(chong)申(shen)(shen)请(qing)(qing)、境外生产药(yao)品再注(zhu)(zhu)册(ce)及复审)5695件,较(jiao)2019年(nian)增长16.06%;受(shou)(shou)理(li)直(zhi)接行政审批的(de)注(zhu)(zhu)册(ce)申(shen)(shen)请(qing)(qing)(无需(xu)技术审评(ping)的(de)补充(chong)申(shen)(shen)请(qing)(qing)、临时进口申(shen)(shen)请(qing)(qing))3092件,较(jiao)2019年(nian)增长64.64%。2020年(nian)行政审批注(zhu)(zhu)册(ce)申(shen)(shen)请(qing)(qing)受(shou)(shou)理(li)的(de)具体情况详(xiang)见表(biao)15。2016-2020年(nian)行政审批注(zhu)(zhu)册(ce)申(shen)(shen)请(qing)(qing)受(shou)(shou)理(li)情况详(xiang)见图25。

 

(2)需审(shen)评审(shen)批的(de)注册申请(qing)受理(li)情况

药审(shen)中(zhong)心受理5695件(jian)需审(shen)评审(shen)批的注册申请中(zhong),临床试(shi)验(yan)申请1618件(jian)(含验(yan)证性(xing)临床)、一致性(xing)评价申请914件(jian)、补充申请2827件(jian)、境外生(sheng)产(chan)药品再注册328件(jian)、复审(shen)8件(jian)。

(3)直接(jie)行政审批的注册(ce)申请受理情况

药(yao)(yao)审中心受(shou)理3092件(jian)直接行(xing)政审批(pi)的(de)注(zhu)册申(shen)请(qing)中,按(an)申(shen)请(qing)类型(xing)划(hua)分(fen),补充申(shen)请(qing)2644件(jian)、临时(shi)进口申(shen)请(qing)448件(jian)。按(an)药(yao)(yao)品(pin)类型(xing)划(hua)分(fen),中药(yao)(yao)156件(jian)、化学药(yao)(yao)2499件(jian)、生物制品(pin)437件(jian)。

 三、重点治疗领域品种

新(xin)冠病毒疫苗(miao)和(he)新(xin)冠肺炎治疗药物(wu):

1.新(xin)型冠(guan)(guan)(guan)(guan)状病(bing)毒灭活疫(yi)苗(miao)(miao)(Vero细胞),为国(guo)内(nei)首个附条件批准的(de)(de)新(xin)冠(guan)(guan)(guan)(guan)病(bing)毒疫(yi)苗(miao)(miao),也是全球首个新(xin)冠(guan)(guan)(guan)(guan)病(bing)毒灭活疫(yi)苗(miao)(miao)。适用于18岁及以上人群预(yu)防由新(xin)型冠(guan)(guan)(guan)(guan)状病(bing)毒(SARS-CoV-2)感染引起的(de)(de)疾(ji)病(bing)。

2.“三药(yao)”品种,为《新(xin)型冠状(zhuang)病(bing)毒(du)肺炎(yan)(yan)诊疗(liao)方案(试行)》推荐药(yao)物(wu),即(ji)连花清瘟颗(ke)(ke)粒/胶囊、金花清感(gan)颗(ke)(ke)粒和血(xue)必(bi)(bi)净注射(she)液。连花清瘟颗(ke)(ke)粒/胶囊和金花清感(gan)颗(ke)(ke)粒新(xin)增适应(ying)症(zheng)用于(yu)(yu)在新(xin)型冠状(zhuang)病(bing)毒(du)肺炎(yan)(yan)的(de)(de)常规治疗(liao)中(zhong)的(de)(de)轻型、普(pu)通型引起的(de)(de)发热、咳嗽、乏力,血(xue)必(bi)(bi)净注射(she)液新(xin)增适应(ying)症(zheng)用于(yu)(yu)新(xin)型冠状(zhuang)病(bing)毒(du)肺炎(yan)(yan)重型、危重型的(de)(de)全身炎(yan)(yan)症(zheng)反应(ying)综合(he)征或/和多(duo)脏器(qi)功能(neng)衰竭(jie),其获批(pi)上(shang)市充分发挥了中(zhong)医药(yao)在疫情防控中(zhong)的(de)(de)作用。

3.注射用(yong)西维来(lai)司他钠,为中性(xing)粒细胞弹(dan)性(xing)蛋白酶选(xuan)择性(xing)抑制剂,适用(yong)于改善伴有全(quan)身性(xing)炎症反应综(zong)合征(zheng)的(de)急性(xing)肺损(sun)伤/急性(xing)呼吸窘迫综(zong)合征(zheng)(ALI/ARDS),是(shi)全(quan)球唯一(yi)用(yong)于ALI/ARDS的(de)药(yao)物,其获批上市填补了我(wo)国(guo)ALI/ARDS药(yao)物治疗领域(yu)的(de)空(kong)白,为我(wo)国(guo)呼吸系(xi)统危重症患者提供用(yong)药(yao)选(xuan)择。

抗肿瘤药(yao)物:

4.甲磺(huang)酸阿美替尼片(pian),为我国首个具有自(zi)主知识产权的第三代(dai)靶(ba)向(xiang)表皮(pi)生长(zhang)因(yin)子受体(EGFR)小分(fen)子酪(lao)氨酸激酶抑制剂(TKI)创新药物,适用于(yu)治(zhi)(zhi)(zhi)疗既往经EGFR-TKI治(zhi)(zhi)(zhi)疗时或治(zhi)(zhi)(zhi)疗后出现疾病进(jin)展,并且经检测确认存在EGFR T790M突(tu)变(bian)阳性(xing)的局部晚期或转移性(xing)非小细胞肺(fei)癌。本品疗效突(tu)出,脑转移病灶控制良好,其获批上市将(jiang)显著改(gai)善该疾病治(zhi)(zhi)(zhi)疗药物的可及性(xing)。

5.索凡替(ti)尼胶囊,为多(duo)靶点、抗(kang)血管生成口服小(xiao)分子酪氨(an)酸激酶抑制剂(ji),是(shi)国内(nei)(nei)首个用于(yu)治(zhi)疗无法(fa)手术(shu)切除(chu)的(de)(de)局(ju)部(bu)晚期或转移性(xing)、进展期非(fei)功(gong)能(neng)性(xing)、分化良好(G1、G2)的(de)(de)非(fei)胰腺来(lai)源的(de)(de)神经内(nei)(nei)分泌(mi)瘤的(de)(de)创新药物。本(ben)品疗效突出,显著降低(di)了此类患者的(de)(de)疾病进展和死亡风(feng)险,其获(huo)批(pi)上市填补了该疾病治(zhi)疗领域的(de)(de)空白。

6.注射(she)用维布妥昔(xi)单抗,为全球首个CD30靶点抗体偶联药物(ADC),也是国内首个用于恶性(xing)淋(lin)(lin)巴瘤(liu)患(huan)(huan)者的(de)ADC药物,适用于治(zhi)疗复(fu)发或难治(zhi)性(xing)的(de)系统性(xing)间变性(xing)大细胞淋(lin)(lin)巴瘤(liu)和经典型霍奇金淋(lin)(lin)巴瘤(liu),本品获批上市为改善我(wo)国此类患(huan)(huan)者的(de)长期生存(cun)提供了有效的(de)治(zhi)疗手段。

7.注(zhu)射用贝(bei)林妥(tuo)欧单抗,为全球(qiu)首个双(shuang)特异(yi)性抗体(ti)(CD3和CD19靶(ba)点)药(yao)物,也是(shi)我国(guo)首个用于肿瘤(liu)适应症的(de)双(shuang)特异(yi)性抗体(ti)药(yao)物,适用于治(zhi)疗成人复发或难治(zhi)性前(qian)体(ti)B细(xi)胞(bao)急(ji)性淋巴(ba)细(xi)胞(bao)白血病(bing)。对于化疗失(shi)败的(de)复发或难治(zhi)性急(ji)性淋巴(ba)细(xi)胞(bao)白血病(bing)患者,与标准化疗相比,本(ben)品可显著(zhu)延长患者生存(cun)期,其获批上(shang)市为我国(guo)此类患者提供了更好(hao)的(de)治(zhi)疗手段。

8.甲磺酸仑(lun)伐替尼胶囊,为(wei)多靶点(dian)、口服(fu)酪氨(an)酸激酶抑(yi)制剂,是国内首个用(yong)于治疗(liao)(liao)(liao)进展性(xing)、局(ju)部晚(wan)期(qi)或转移性(xing)放射性(xing)碘(dian)难治性(xing)分化型甲状腺癌(ai)的小分子药(yao)物。本品(pin)疗(liao)(liao)(liao)效(xiao)突出,其(qi)获批(pi)上市(shi)为(wei)我国此类患者提供了有效(xiao)的治疗(liao)(liao)(liao)方案(an),填(tian)补了该治疗(liao)(liao)(liao)领(ling)域的空白。

抗(kang)感染药物:

9.盐(yan)酸可(ke)洛派(pai)韦(wei)胶囊,为非结(jie)构蛋(dan)白5A(NS5A)抑制剂,是(shi)我国具有(you)自主知识产权(quan)的广谱、直接抗丙肝(gan)病(bing)毒创新(xin)药物,适用于(yu)与索磷布韦(wei)联用治疗(liao)初治或(huo)干(gan)扰素经治的基因1、2、3、6型成人慢(man)性丙型肝(gan)炎病(bing)毒感染,可(ke)合并或(huo)不合并代偿性肝(gan)硬化,本品获(huo)批上市为我国慢(man)性丙肝(gan)患者(zhe)提(ti)供了一种新(xin)的治疗(liao)选(xuan)择。

10.恩(en)曲他滨(bin)替诺福韦片,增(zeng)加(jia)适应症用于(yu)降低成人和青少(shao)年(体重至少(shao)在(zai)35 kg以上(shang)(shang))通(tong)过高风险(xian)性行为(wei)获得HIV-1的(de)风险(xian),是(shi)国内首个(ge)用于(yu)暴(bao)露前预防HIV的(de)药物。HIV感(gan)染是(shi)重大(da)公共(gong)卫(wei)生(sheng)问题,本(ben)品获批上(shang)(shang)市对于(yu)控制(zhi)HIV传播具(ju)有重大(da)意义。

循环系(xi)统药物:

11.拉那利尤单(dan)抗(kang)注射液,为(wei)全人源化单(dan)克隆抗(kang)体(IgG1/K-轻链),是我(wo)(wo)国首个用于12岁及(ji)以上(shang)(shang)患者预(yu)(yu)防(fang)遗传(chuan)性血管性水肿(HAE)发作(zuo)的药物。HAE疾病反复(fu)发作(zuo),近半数患者可(ke)出(chu)现上(shang)(shang)呼吸(xi)道黏膜水肿引发窒息而(er)危及(ji)生命,本品(pin)获(huo)批上(shang)(shang)市为(wei)我(wo)(wo)国HAE患者预(yu)(yu)防(fang)发作(zuo)提供(gong)了安(an)全有效(xiao)的治疗手段。

12.氯(lv)苯(ben)唑酸软胶(jiao)囊,为(wei)转(zhuan)(zhuan)甲状腺(xian)素蛋(dan)白(TTR)稳(wen)定剂(ji),适(shi)用(yong)于(yu)治疗(liao)转(zhuan)(zhuan)甲状腺(xian)素蛋(dan)白淀粉样变(bian)性(xing)心(xin)肌病(bing)(bing)(bing),以减(jian)少心(xin)血(xue)管(guan)死亡及心(xin)血(xue)管(guan)相关住(zhu)院。该疾病(bing)(bing)(bing)是一种(zhong)致命性(xing)疾病(bing)(bing)(bing),属罕(han)见病(bing)(bing)(bing),本品为(wei)我国(guo)(guo)首个针对(dui)该病(bing)(bing)(bing)病(bing)(bing)(bing)因治疗(liao)的药物,其(qi)获批上市为(wei)我国(guo)(guo)此类患者提供了新的治疗(liao)手段。

呼吸系(xi)统(tong)药(yao)物:

13.苯环(huan)喹溴铵(an)鼻喷(pen)雾剂,为胆碱能受体(ti)拮(jie)抗剂,为我(wo)国首个具有自主知识产权(quan)用于(yu)(yu)变(bian)应(ying)性(xing)鼻炎的鼻用抗胆碱创(chuang)新(xin)(xin)药物,适用于(yu)(yu)改善(shan)变(bian)应(ying)性(xing)鼻炎引起的流涕(ti)、鼻塞、鼻痒(yang)和喷(pen)嚏(ti)症状,本品(pin)其获(huo)批上市(shi)可为我(wo)国此类患者提(ti)供新(xin)(xin)的治疗(liao)选择(ze)。

14.乙磺酸(suan)尼(ni)达尼(ni)布软胶囊,为小分(fen)子酪(lao)氨(an)酸(suan)激酶(mei)抑(yi)制剂(ji),具(ju)有(you)抗(kang)纤(xian)维(wei)化(hua)作(zuo)用(yong),增加适应(ying)症用(yong)于治(zhi)疗系统性(xing)(xing)(xing)(xing)硬化(hua)病(bing)相(xiang)关间质(zhi)性(xing)(xing)(xing)(xing)肺(fei)疾(ji)(ji)病(bing)(SSc-ILD)和具(ju)有(you)进行性(xing)(xing)(xing)(xing)表(biao)型的慢性(xing)(xing)(xing)(xing)纤(xian)维(wei)化(hua)性(xing)(xing)(xing)(xing)间质(zhi)性(xing)(xing)(xing)(xing)肺(fei)疾(ji)(ji)病(bing)(PF-ILD)。目前可(ke)用(yong)于SSc-ILD和PF-ILD的有(you)效治(zhi)疗方式有(you)限,临(lin)床用(yong)药需(xu)求迫切,本品获批(pi)新增适应(ying)症可(ke)以填(tian)补该治(zhi)疗领(ling)域空白(bai),为我国(guo)此(ci)类患(huan)者提供药物选择。

神经系统药物(wu):

15.氘丁苯那嗪片,为囊泡单(dan)(dan)胺转运蛋白(bai)2(VMAT2)抑(yi)制剂,是我国(guo)首个用于治(zhi)疗与(yu)罕见病亨廷顿(dun)病有(you)关的舞蹈病、迟发性运动障(zhang)碍的药物,属临床(chuang)急需境(jing)外新(xin)药名单(dan)(dan)品种(zhong),本品获批上市(shi)满足了我国(guo)此类患(huan)者(zhe)迫切(qie)的临床(chuang)需求。

16.氯苯(ben)唑酸葡胺软胶囊,为转甲状腺素(su)蛋白(TTR)稳定剂,是我国首个用(yong)于(yu)治(zhi)疗成人转甲状腺素(su)蛋白淀(dian)粉样变性(xing)多发性(xing)神经病(bing)I期症状患者、延(yan)缓周围(wei)神经功(gong)能(neng)损害的(de)药物,属临(lin)床急(ji)需境外新药名单品种,其获批(pi)上市(shi)改(gai)变了该病(bing)无药可(ke)治(zhi)的(de)局面。

镇痛药及麻醉科药物(wu):

17.环泊酚注射液(ye),为GABAA受(shou)体激动剂,是用(yong)于(yu)消(xiao)化道内(nei)镜检(jian)查(cha)中镇(zhen)静的(de)创新药(yao)物(wu)。本品与(yu)临床常用(yong)麻(ma)醉镇(zhen)静药(yao)物(wu)丙泊酚具(ju)有相似的(de)药(yao)理(li)机制(zhi),但具(ju)有起效快,注射痛少,呼吸抑制(zhi)轻,恢(hui)复速度快等(deng)优势(shi)特征,其获批上市可为我国(guo)消(xiao)化内(nei)镜检(jian)查(cha)操(cao)作用(yong)药(yao)提供新的(de)选择。

皮肤五(wu)官药物:

18.塞奈吉明滴(di)眼(yan)液,为国内(nei)首个(ge)用(yong)于治疗(liao)神经营养性角膜炎(NK)的(de)(de)(de)重组人(ren)神经生(sheng)长因子(rhNGF)药物,属临床急需境(jing)外(wai)新药名单品(pin)种。NK为罕见的(de)(de)(de)退行性角膜疾病,可致(zhi)盲,中(zhong)重度NK手术治疗(liao)为侵入性操作,费用(yong)高(gao)且不能永久治愈,本品(pin)获批上市(shi)为我国此类患者(zhe)提供了有效的(de)(de)(de)治疗(liao)药物,预(yu)计将成为中(zhong)重度NK患者(zhe)的(de)(de)(de)首选治疗(liao)。

19.度普利尤(you)单(dan)(dan)抗(kang)注射液,为(wei)重(zhong)组人免疫球(qiu)蛋白(bai)-G4单(dan)(dan)克隆抗(kang)体,适(shi)用(yong)于治(zhi)疗(liao)外用(yong)处方(fang)药控制不佳(jia)或不建议使用(yong)外用(yong)处方(fang)药的成(cheng)人中重(zhong)度特(te)应性(xing)皮炎,属临床急需境(jing)外新药名单(dan)(dan)品(pin)种。与现有治(zhi)疗(liao)方(fang)式相比,本品(pin)有明显临床优势,其获批上市(shi)为(wei)此类(lei)难治(zhi)性(xing)严重(zhong)疾病患者提供了治(zhi)疗(liao)选择(ze)。

消化(hua)系统药物:

20.注射(she)用(yong)(yong)维得利珠(zhu)单(dan)(dan)抗,为作用(yong)(yong)于人(ren)淋巴细胞整合素α4β7的(de)(de)人(ren)源化单(dan)(dan)克(ke)(ke)隆抗体(ti),适用(yong)(yong)于治疗对传统治疗或(huo)肿瘤(liu)坏(huai)死因(yin)子(zi)α(TNF-α)抑制剂(ji)(ji)应答不充分、失应答或(huo)不耐受的(de)(de)中度至重度活(huo)动性(xing)溃(kui)疡性(xing)结肠炎、克(ke)(ke)罗(luo)恩(en)病(bing),属临床急需(xu)境外(wai)新药名单(dan)(dan)品(pin)种。此类疾(ji)病(bing)存(cun)在迫切的(de)(de)临床治疗需(xu)求,特别是对于TNF-α拮抗剂(ji)(ji)治疗失败(bai)的(de)(de)患者,本品(pin)获批上市可为临床提(ti)供新的(de)(de)治疗选择。

外(wai)科药物:

21.注射用丹曲(qu)林钠,适用于预(yu)防及治疗恶(e)性(xing)高热(MH),是目前唯一短时间内给药(yao)可(ke)改(gai)变该(gai)疾(ji)病转归的(de)药(yao)物。MH临(lin)床(chuang)结局危重,死亡率高,其获批上(shang)市(shi)可(ke)改(gai)变目前国内MH无安全(quan)有(you)效治疗手段的(de)现(xian)状,满足(zu)迫切临(lin)床(chuang)需求。

22.他(ta)克莫司颗粒(li),适(shi)用(yong)于(yu)预防儿童肝(gan)脏(zang)或肾(shen)脏(zang)移植(zhi)术后的移植(zhi)物排斥反应,治(zhi)疗儿童肝(gan)脏(zang)或肾(shen)脏(zang)移植(zhi)术后应用(yong)其他(ta)免疫抑制药(yao)物无法(fa)控制的移植(zhi)物排斥反应,属(shu)儿童用(yong)药(yao),本品获(huo)批上市(shi)可极大解(jie)决我国(guo)儿科肝(gan)肾(shen)移植(zhi)患(huan)者未满足(zu)的临床(chuang)需求。

罕见病药物:

23.注射用拉(la)罗尼酶(mei)浓溶液,为国内(nei)首个用于(yu)罕见病(bing)黏(nian)多糖贮积症I型(MPS I,α-L-艾(ai)杜糖苷酶(mei)缺乏症)的酶(mei)替代治疗(liao)药(yao)物,属临床(chuang)急需境外新药(yao)名(ming)单(dan)品种。黏(nian)多糖贮积症I型是一(yi)种严重危及生(sheng)命(ming)且国内(nei)尚无有效(xiao)治疗(liao)手段的遗传性罕见病(bing),已列入(ru)我国第一(yi)批罕见病(bing)目录,本(ben)品获(huo)批上(shang)市(shi)填补了我国此(ci)类患者的用药(yao)空白。

24.艾度(du)硫酸酯酶β注射液,为国(guo)内(nei)首个用(yong)于(yu)罕见病黏多(duo)糖贮积症(zheng)Ⅱ型(MPS Ⅱ,亨(heng)特综合征)的(de)(de)酶替代治(zhi)疗药物。黏多(duo)糖贮积症(zheng)Ⅱ型是一种(zhong)严重危及生命且(qie)国(guo)内(nei)尚无有(you)效治(zhi)疗手段的(de)(de)遗传性罕见病,已列入我国(guo)第一批(pi)罕见病目录,本品(pin)获批(pi)上市填补了我国(guo)此类患者的(de)(de)用(yong)药空白。

体内诊断试(shi)剂(ji):

25.重组结核杆菌融(rong)合(he)蛋白(EC),适用(yong)于(yu)6月龄及以(yi)上(shang)婴儿(er)、儿(er)童(tong)及65周岁(sui)以(yi)下成人结核杆菌感染(ran)诊(zhen)断,并可(ke)用(yong)于(yu)辅助结核病(bing)的临(lin)床(chuang)诊(zhen)断,为(wei)全球首个用(yong)于(yu)鉴别卡介苗接(jie)种与结核杆菌感染(ran)的体内诊(zhen)断产品,其(qi)获批(pi)上(shang)市为(wei)临(lin)床(chuang)鉴别诊(zhen)断提供(gong)了新(xin)的手段。

预防用生(sheng)物(wu)制品(pin)(疫苗):

26.鼻喷冻(dong)干(gan)流感减毒(du)活疫苗:为国内(nei)首家以(yi)鼻喷途(tu)径(jing)接种的(de)(de)疫苗,适用于3(36月龄)~17岁人群用于预防(fang)由疫苗相关型别(bie)的(de)(de)流感病(bing)毒(du)引(yin)起(qi)的(de)(de)流行性感冒(mao),接种后可刺激机体产生(sheng)抗流感病(bing)毒(du)的(de)(de)免疫力。

中药(yao)(yao)新药(yao)(yao):

27.桑(sang)枝(zhi)总生物碱片(pian),其(qi)主要成分(fen)为(wei)桑(sang)枝(zhi)中提取得到的桑(sang)枝(zhi)总生物碱,是近10年来(lai)首个获(huo)批上市(shi)(shi)的抗糖(tang)(tang)尿病(bing)(bing)(bing)中药新药,适用于配合饮食控制及(ji)运动(dong)、治(zhi)疗(liao)2型糖(tang)(tang)尿病(bing)(bing)(bing)。本品可有效(xiao)降(jiang)低2型糖(tang)(tang)尿病(bing)(bing)(bing)受试者糖(tang)(tang)化血红蛋白水(shui)平(ping),其(qi)获(huo)批上市(shi)(shi)为(wei)2型糖(tang)(tang)尿病(bing)(bing)(bing)患者提供新的治(zhi)疗(liao)选(xuan)择。

28.筋骨止(zhi)(zhi)痛凝胶(jiao),为醋(cu)延胡索、川芎(xiong)等12种药(yao)味组成(cheng)的中(zhong)药(yao)复(fu)方新药(yao),适用于膝骨关(guan)节(jie)炎(yan)肾虚筋脉瘀滞证的症状改善,具有“活(huo)血理气,祛风除湿,通络止(zhi)(zhi)痛”的功(gong)效。本品为外用凝胶(jiao)制剂,药(yao)物中(zhong)各成(cheng)分通过(guo)透皮吸(xi)收而发(fa)挥作用,可避免肠胃(wei)吸(xi)收和肝脏首过(guo)代(dai)谢,其(qi)获(huo)批(pi)上市(shi)可为膝关(guan)节(jie)骨性关(guan)节(jie)炎(yan)患者提供新的治疗(liao)选(xuan)择。

29.连花(hua)清咳片(pian),为麻黄、桑白皮等(deng)15种药味组成的(de)中(zhong)药新药,适用于治疗急性(xing)气(qi)管-支(zhi)气(qi)管炎(yan)(yan)痰(tan)热壅(yong)肺证引起(qi)的(de)咳嗽、咳痰(tan)等(deng),具有“宣肺泄热,化痰(tan)止咳”的(de)功效,其获批上(shang)市可为急性(xing)气(qi)管-支(zhi)气(qi)管炎(yan)(yan)患(huan)者提供新的(de)治疗选择。

四(si)、全力做好(hao)应急审评工作

(一(yi))加强统(tong)一(yi)领导,制定工作程序

按(an)照国家药(yao)(yao)监局(ju)党(dang)组(zu)(zu)(zu)(zu)关(guan)于(yu)疫情防控应急审(shen)评(ping)审(shen)批工作(zuo)(zuo)(zuo)部署,药(yao)(yao)审(shen)中心(xin)闻令而动,一是充分发挥(hui)集体(ti)决(jue)策作(zuo)(zuo)(zuo)用,迅速成(cheng)立(li)抗新(xin)(xin)型(xing)(xing)冠(guan)状(zhuang)病(bing)(bing)(bing)毒药(yao)(yao)物特别审(shen)评(ping)领(ling)导小组(zu)(zu)(zu)(zu),抽调16个(ge)部门(men)148名骨干力量(liang)为工作(zuo)(zuo)(zuo)小组(zu)(zu)(zu)(zu)成(cheng)员,先后(hou)召开(kai)特别审(shen)评(ping)领(ling)导小组(zu)(zu)(zu)(zu)会议6次和领(ling)导小组(zu)(zu)(zu)(zu)专题会18次,明晰工作(zuo)(zuo)(zuo)原(yuan)则,优化(hua)工作(zuo)(zuo)(zuo)流程(cheng),及时研(yan)究解决(jue)应急审(shen)评(ping)过程(cheng)中遇(yu)到(dao)的问题,保证工作(zuo)(zuo)(zuo)顺利推进、有(you)序(xu)开(kai)展。二是制定工作(zuo)(zuo)(zuo)程(cheng)序(xu),形(xing)成(cheng)1个(ge)方案、2个(ge)程(cheng)序(xu)、1个(ge)规范,即《药(yao)(yao)审(shen)中心(xin)抗新(xin)(xin)型(xing)(xing)冠(guan)状(zhuang)病(bing)(bing)(bing)毒药(yao)(yao)物特别审(shen)评(ping)工作(zuo)(zuo)(zuo)方案》《关(guan)于(yu)新(xin)(xin)型(xing)(xing)冠(guan)状(zhuang)病(bing)(bing)(bing)毒(2019-nCoV)药(yao)(yao)物立(li)项申请(qing)评(ping)议工作(zuo)(zuo)(zuo)程(cheng)序(xu)》《关(guan)于(yu)新(xin)(xin)型(xing)(xing)冠(guan)状(zhuang)病(bing)(bing)(bing)毒(2019-nCoV)药(yao)(yao)物特别专家组(zu)(zu)(zu)(zu)评(ping)估和审(shen)核工作(zuo)(zuo)(zuo)程(cheng)序(xu)》《国家药(yao)(yao)监局(ju)抗新(xin)(xin)型(xing)(xing)冠(guan)状(zhuang)病(bing)(bing)(bing)毒药(yao)(yao)物专家会议管理规范》。三是严格落(luo)实(shi)“安全守底(di)线(xian)、疗效有(you)证据、质量(liang)能保证、审(shen)评(ping)超常规”的工作(zuo)(zuo)(zuo)要求(qiu),按(an)照工作(zuo)(zuo)(zuo)程(cheng)序(xu),依法依规、科学规范审(shen)评(ping),标准不(bu)降,加速审(shen)批。

(二)发挥专(zhuan)家(jia)作用,解决技术难题(ti)

一是组(zu)(zu)建(jian)特别(bie)专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)组(zu)(zu)。按照《国家(jia)(jia)(jia)(jia)食品(pin)(pin)药(yao)品(pin)(pin)监(jian)(jian)督管(guan)理局(ju)(ju)药(yao)品(pin)(pin)特别(bie)审(shen)(shen)批(pi)程(cheng)序》(原(yuan)国家(jia)(jia)(jia)(jia)食品(pin)(pin)药(yao)品(pin)(pin)监(jian)(jian)督管(guan)理局(ju)(ju)令(ling)第21号)规定(ding)和国家(jia)(jia)(jia)(jia)药(yao)监(jian)(jian)局(ju)(ju)新(xin)型冠状病毒感染(ran)肺炎疫(yi)情应对(dui)工作(zuo)组(zu)(zu)药(yao)品(pin)(pin)组(zu)(zu)的决(jue)定(ding),药(yao)审(shen)(shen)中心(xin)先后遴选出多位院士(shi)和知(zhi)名专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)组(zu)(zu)成了特别(bie)专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)组(zu)(zu),经(jing)国家(jia)(jia)(jia)(jia)药(yao)监(jian)(jian)局(ju)(ju)批(pi)准后开展(zhan)工作(zuo)。遇到新(xin)的技(ji)(ji)(ji)术(shu)难点(dian)问题时(shi),听取专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)意见建(jian)议(yi)后,由专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)投(tou)票(piao)表决(jue)。二是注(zhu)重发(fa)挥专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)技(ji)(ji)(ji)术(shu)支撑(cheng)作(zuo)用(yong)。通过专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)研(yan)讨会(hui)和专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)咨询会(hui)解决(jue)特定(ding)技(ji)(ji)(ji)术(shu)问题,例如针对(dui)mRNA新(xin)冠病毒疫(yi)苗在研(yan)发(fa)上存(cun)在的难点(dian)和潜(qian)在的风险,药(yao)审(shen)(shen)中心(xin)组(zu)(zu)织专(zhuan)(zhuan)(zhuan)(zhuan)家(jia)(jia)(jia)(jia)形成技(ji)(ji)(ji)术(shu)指导原(yuan)则,以(yi)指导相(xiang)关企业的研(yan)发(fa)。

(三)实时高(gao)效沟通,提高(gao)研发进(jin)度(du)

一(yi)是遵循(xun)“早期介(jie)入、持续跟(gen)进(jin)、主动服务”的工作要求,第一(yi)时(shi)间(jian)组织审评(ping)(ping)力量对咨(zi)询品(pin)种或(huo)注(zhu)册(ce)申(shen)请立项(xiang)的科(ke)学性和可行性进(jin)行评(ping)(ping)议,并在(zai)24小时(shi)内(nei)与申(shen)请人进(jin)行沟通交(jiao)流,保证申(shen)请人尽快提交(jiao)特别审批注(zhu)册(ce)申(shen)请。二是加强国(guo)际(ji)合(he)作。积极参加世(shi)界卫生组织(WHO)、国(guo)际(ji)药品(pin)监(jian)管机构(gou)联盟(ICMRA)等组织召开的视频电话(hua)会议,共(gong)同探讨研发(fa)审评(ping)(ping)标准,了解新冠(guan)病毒疫苗研发(fa)信息,指导(dao)推(tui)动研发(fa)企业赴国(guo)外开展Ⅲ期临床(chuang)试验。

(四)探索(suo)研审联动(dong),坚持科学审评

一是探索建立研(yan)发(fa)审(shen)评联动工作(zuo)机制(zhi)。边(bian)研(yan)发(fa)、边(bian)提交、边(bian)审(shen)评,为新(xin)冠(guan)病毒疫(yi)(yi)苗研(yan)发(fa)争取到了(le)宝贵(gui)时(shi)间,确保新(xin)冠(guan)病毒疫(yi)(yi)苗等研(yan)发(fa)走(zou)在(zai)世界前列。通(tong)过这种工作(zuo)机制(zhi),大大缩(suo)短(duan)了(le)审(shen)评时(shi)间。二是建立技术(shu)(shu)标准体系。针对新(xin)冠(guan)病毒的特点(dian),及(ji)时(shi)制(zhi)定(ding)新(xin)冠(guan)病毒疫(yi)(yi)苗、新(xin)冠(guan)肺炎治疗药物研(yan)发(fa)技术(shu)(shu)指导原则等28个技术(shu)(shu)文件,指导企(qi)业高(gao)标准研(yan)发(fa),少走(zou)弯路(lu),科(ke)学开展审(shen)评。

 五、鼓励(li)中药传承创新发展

贯彻落实习近(jin)平总(zong)书(shu)记关于(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)重要(yao)(yao)指(zhi)(zhi)示精神、《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)共中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)央(yang) 国(guo)务(wu)院关于(yu)促(cu)进(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)传(chuan)(chuan)承创新(xin)(xin)(xin)(xin)(xin)发(fa)展(zhan)(zhan)的(de)(de)意见》及(ji)国(guo)家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)局(ju)(ju)要(yao)(yao)求(qiu)(qiu)(qiu),药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)审中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)心从改革(ge)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册分(fen)类、健全(quan)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)等(deng)各(ge)方(fang)面积极鼓励中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)守正(zheng)创新(xin)(xin)(xin)(xin)(xin)。一(yi)(yi)是(shi)推(tui)动中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)传(chuan)(chuan)承发(fa)展(zhan)(zhan)。起草并(bing)由国(guo)家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)局(ju)(ju)发(fa)布(bu)《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册分(fen)类及(ji)申(shen)(shen)(shen)报资料要(yao)(yao)求(qiu)(qiu)(qiu)》,丰富(fu)古(gu)代经典名(ming)方(fang)复方(fang)制(zhi)(zhi)(zhi)剂(ji)的(de)(de)范围,促(cu)进(jin)古(gu)代经典名(ming)方(fang)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)制(zhi)(zhi)(zhi)剂(ji)研(yan)(yan)(yan)发(fa),推(tui)动其向新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)转化。二是(shi)建(jian)立完善符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)点(dian)的(de)(de)质(zhi)(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)体(ti)系(xi)(xi)。遵循(xun)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)点(dian)和(he)研(yan)(yan)(yan)发(fa)规律,将中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)独(du)特(te)(te)的(de)(de)理(li)(li)论体(ti)系(xi)(xi)和(he)实践特(te)(te)点(dian)、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)剂(ji)质(zhi)(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)特(te)(te)点(dian)与药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品质(zhi)(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)的(de)(de)一(yi)(yi)般要(yao)(yao)求(qiu)(qiu)(qiu)有机(ji)结(jie)合(he),研(yan)(yan)(yan)究(jiu)(jiu)(jiu)构建(jian)完善符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)剂(ji)特(te)(te)点(dian)的(de)(de)质(zhi)(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)方(fang)法(fa)和(he)策略(lve),制(zhi)(zhi)(zhi)定《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)饮(yin)片炮制(zhi)(zhi)(zhi)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)(试(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang)(liang)标(biao)准(zhun)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)(试(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)制(zhi)(zhi)(zhi)剂(ji)生(sheng)产(chan)工(gong)艺研(yan)(yan)(yan)究(jiu)(jiu)(jiu)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)(试(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)生(sheng)物效应(ying)检测研(yan)(yan)(yan)究(jiu)(jiu)(jiu)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)(试(shi)行(xing))》等(deng)8个(ge)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)。三是(shi)健全(quan)符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)点(dian)的(de)(de)审评(ping)体(ti)系(xi)(xi)。引入新(xin)(xin)(xin)(xin)(xin)工(gong)具、新(xin)(xin)(xin)(xin)(xin)方(fang)法(fa)、新(xin)(xin)(xin)(xin)(xin)标(biao)准(zhun)用(yong)于(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)疗效评(ping)价(jia),细(xi)化申(shen)(shen)(shen)报资料要(yao)(yao)求(qiu)(qiu)(qiu),制(zhi)(zhi)(zhi)定《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)于(yu)慢性(xing)便秘临(lin)床(chuang)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)于(yu)糖尿病(bing)肾病(bing)临(lin)床(chuang)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)》等(deng)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze),探(tan)索构建(jian)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)理(li)(li)论、人用(yong)经验(yan)和(he)临(lin)床(chuang)试(shi)验(yan)相结(jie)合(he)的(de)(de)审评(ping)证据体(ti)系(xi)(xi)。四是(shi)全(quan)力做好中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)别审评(ping)工(gong)作(zuo)(zuo)。充分(fen)发(fa)扬抗疫精神,制(zhi)(zhi)(zhi)定了(le)《用(yong)于(yu)新(xin)(xin)(xin)(xin)(xin)冠(guan)肺炎中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册申(shen)(shen)(shen)请(qing)特(te)(te)别审批(pi)申(shen)(shen)(shen)报资料要(yao)(yao)求(qiu)(qiu)(qiu)(试(shi)行(xing))》《用(yong)于(yu)新(xin)(xin)(xin)(xin)(xin)冠(guan)肺炎中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册申(shen)(shen)(shen)请(qing)特(te)(te)别审批(pi)技(ji)术(shu)(shu)指(zhi)(zhi)导(dao)原(yuan)(yuan)则(ze)(试(shi)行(xing))》等(deng),指(zhi)(zhi)导(dao)应(ying)急状(zhuang)态(tai)下的(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)审评(ping)。截至2020年(nian)12月31日,“三方(fang)”中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)的(de)(de)清(qing)肺排(pai)毒(du)颗(ke)粒(li)、化湿败毒(du)颗(ke)粒(li)的(de)(de)IND申(shen)(shen)(shen)请(qing)已获批(pi)准(zhun),“三药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)”连花清(qing)瘟(wen)颗(ke)粒(li)/胶囊、金(jin)花清(qing)感(gan)颗(ke)粒(li)、血必(bi)净注(zhu)射液(ye)获批(pi)增加用(yong)于(yu)治疗新(xin)(xin)(xin)(xin)(xin)冠(guan)肺炎的(de)(de)适(shi)应(ying)症。五是(shi)赴武汉(han)开展(zhan)(zhan)实地(di)(di)调研(yan)(yan)(yan)和(he)座(zuo)谈,持续(xu)推(tui)进(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)管(guan)科学“以临(lin)床(chuang)价(jia)值为导(dao)向的(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)安全(quan)性(xing)评(ping)价(jia)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)”课题研(yan)(yan)(yan)究(jiu)(jiu)(jiu)。六是(shi)开展(zhan)(zhan)援(yuan)疆援(yuan)藏(zang)工(gong)作(zuo)(zuo),赴西藏(zang)开展(zhan)(zhan)实地(di)(di)调研(yan)(yan)(yan)、与新(xin)(xin)(xin)(xin)(xin)疆维吾(wu)尔自治区药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品监(jian)督管(guan)理(li)(li)局(ju)(ju)召(zhao)开线上座(zuo)谈交(jiao)流会,支持民(min)族药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)发(fa)展(zhan)(zhan)。

  六、加强(qiang)《药品注册(ce)管(guan)理办法》配(pei)套(tao)文件制修订

新(xin)修订(ding)的(de)(de)《药(yao)品注(zhu)册(ce)(ce)管理办(ban)法》是(shi)贯彻党中(zhong)央、国(guo)务院审评(ping)审批制度改(gai)革精神和落实(shi)新(xin)修订(ding)《药(yao)品管理法》的(de)(de)重要(yao)规(gui)章(zhang),考虑(lv)到药(yao)品注(zhu)册(ce)(ce)管理中(zhong)的(de)(de)具体(ti)技(ji)(ji)术(shu)要(yao)求,需(xu)要(yao)跟随(sui)技(ji)(ji)术(shu)发展的(de)(de)脚步不断调整完善,在(zai)规(gui)章(zhang)中(zhong)不适宜作出具体(ti)的(de)(de)规(gui)定,因此(ci)这些具体(ti)技(ji)(ji)术(shu)要(yao)求在(zai)《药(yao)品注(zhu)册(ce)(ce)管理办(ban)法》发布(bu)后,以配套文件、技(ji)(ji)术(shu)指导(dao)原则等(deng)形式发布(bu),既(ji)能更好地顺应药(yao)品研发的(de)(de)科学规(gui)律,也能确保新(xin)旧《药(yao)品注(zhu)册(ce)(ce)管理办(ban)法》的(de)(de)平稳过渡和新(xin)《药(yao)品注(zhu)册(ce)(ce)管理办(ban)法》的(de)(de)顺利实(shi)施。

根据国家局(ju)部署,药审中心统(tong)筹(chou)协调,加大配套(tao)(tao)文(wen)件(jian)的制修订力(li)(li)度(du),成(cheng)立课(ke)题组(zu),对重点难点问题开(kai)展(zhan)(zhan)调研(yan)攻(gong)关,充分(fen)听取(qu)专家、业界意见,力(li)(li)求达成(cheng)共识,共参与了48个配套(tao)(tao)文(wen)件(jian)制修订工作,其(qi)中牵头起草配套(tao)(tao)文(wen)件(jian)30个。自(zi)开(kai)展(zhan)(zhan)工作以来,已(yi)基本完成(cheng)配套(tao)(tao)文(wen)件(jian)公(gong)开(kai)征(zheng)求意见工作,部分(fen)文(wen)件(jian)已(yi)经国家局(ju)审核同意后发(fa)布实施,有(you)效确保(bao)了各项审评任(ren)务不断、不散(san)、不乱,新旧注册相关规(gui)定的顺利过渡和实施。

 七、加快审(shen)评技(ji)术标准体系建设

在药(yao)品审(shen)评(ping)和(he)研发(fa)过(guo)程(cheng)中(zhong),指导原则(ze)兼具监(jian)管(guan)依据和(he)技(ji)术要求(qiu)的(de)双重职能(neng)。《药(yao)品注册管(guan)理办法(fa)》明(ming)确从(cong)事药(yao)物研制和(he)药(yao)品注册活(huo)动,应(ying)当遵(zun)守有关(guan)法(fa)律、法(fa)规(gui)、规(gui)章、标准(zhun)和(he)规(gui)范;药(yao)审(shen)中(zhong)心等(deng)专(zhuan)业技(ji)术机(ji)构,应(ying)当根(gen)据科学(xue)进展(zhan)、行业发(fa)展(zhan)实际和(he)药(yao)品监(jian)督(du)管(guan)理工作需要制定技(ji)术指导原则(ze)和(he)程(cheng)序(xu),并(bing)向(xiang)社(she)会公布。

药(yao)(yao)品(pin)技术(shu)指(zhi)导(dao)原(yuan)则(ze)体系(xi)(xi)的(de)(de)建(jian)立与(yu)完(wan)善(shan),是落实“四个最(zui)严”要求(qiu)的(de)(de)最(zui)好实践(jian),是药(yao)(yao)审中(zhong)心(xin)(xin)推进审评(ping)(ping)体系(xi)(xi)和(he)(he)审评(ping)(ping)能力现代(dai)化的(de)(de)重要举(ju)措。药(yao)(yao)审中(zhong)心(xin)(xin)通过“定标(biao)准(zhun)(zhun)、定程(cheng)(cheng)序(xu)(xu)、定计划(hua)”三步(bu)走的(de)(de)方式,统筹规(gui)划(hua)以(yi)指(zhi)导(dao)原(yuan)则(ze)为核(he)心(xin)(xin)的(de)(de)审评(ping)(ping)标(biao)准(zhun)(zhun)体系(xi)(xi)建(jian)设,围绕药(yao)(yao)品(pin)研发(fa)需(xu)求(qiu)和(he)(he)鼓励创新(xin)的(de)(de)原(yuan)则(ze),对标(biao)国(guo)际先(xian)进监(jian)(jian)管(guan)机构(gou)技术(shu)标(biao)准(zhun)(zhun),加大指(zhi)导(dao)原(yuan)则(ze)制(zhi)定和(he)(he)公开力度。2020年共开展了119个技术(shu)指(zhi)导(dao)原(yuan)则(ze)制(zhi)修订(ding)工作,根据《国(guo)家药(yao)(yao)监(jian)(jian)局综合(he)司关于印发(fa)药(yao)(yao)品(pin)技术(shu)指(zhi)导(dao)原(yuan)则(ze)发(fa)布程(cheng)(cheng)序(xu)(xu)的(de)(de)通知》(药(yao)(yao)监(jian)(jian)综药(yao)(yao)管(guan)〔2020〕9号)要求(qiu),截至2020年12月31日,药(yao)(yao)审中(zhong)心(xin)(xin)已(yi)经国(guo)家药(yao)(yao)监(jian)(jian)局审查同意发(fa)布了71个指(zhi)导(dao)原(yuan)则(ze),详见(jian)附(fu)件6。

在(zai)应对新(xin)(xin)(xin)型冠状病(bing)毒(du)肺(fei)炎(yan)、促进(jin)新(xin)(xin)(xin)冠病(bing)毒(du)疫苗和(he)新(xin)(xin)(xin)冠肺(fei)炎(yan)治疗(liao)(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)的研(yan)(yan)发(fa)(fa)和(he)审(shen)(shen)评(ping)(ping)质(zhi)(zhi)量(liang)(liang)(liang)、速(su)度方(fang)面(mian),药(yao)(yao)(yao)(yao)(yao)审(shen)(shen)中心发(fa)(fa)布了《新(xin)(xin)(xin)型冠状病(bing)毒(du)预(yu)防用(yong)疫苗研(yan)(yan)发(fa)(fa)技(ji)(ji)术(shu)(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)(试行(xing))》等(deng)(deng)(deng)7个指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze);在(zai)着力提升中药(yao)(yao)(yao)(yao)(yao)材(cai)质(zhi)(zhi)量(liang)(liang)(liang)研(yan)(yan)究(jiu)(jiu),鼓励中药(yao)(yao)(yao)(yao)(yao)研(yan)(yan)发(fa)(fa)与(yu)创新(xin)(xin)(xin)方(fang)面(mian),发(fa)(fa)布了《中药(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)用(yong)药(yao)(yao)(yao)(yao)(yao)材(cai)质(zhi)(zhi)量(liang)(liang)(liang)控制(zhi)(zhi)(zhi)(zhi)研(yan)(yan)究(jiu)(jiu)技(ji)(ji)术(shu)(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)(试行(xing))》《中药(yao)(yao)(yao)(yao)(yao)复方(fang)制(zhi)(zhi)(zhi)(zhi)剂(ji)生(sheng)(sheng)产工(gong)艺(yi)研(yan)(yan)究(jiu)(jiu)技(ji)(ji)术(shu)(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)(试行(xing))》《中药(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)用(yong)于慢性便秘临(lin)床(chuang)研(yan)(yan)究(jiu)(jiu)技(ji)(ji)术(shu)(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)》等(deng)(deng)(deng)10个指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze);在(zai)鼓励儿童(tong)药(yao)(yao)(yao)(yao)(yao)物(wu)研(yan)(yan)发(fa)(fa)方(fang)面(mian),发(fa)(fa)布了《真实世界研(yan)(yan)究(jiu)(jiu)支持(chi)儿童(tong)药(yao)(yao)(yao)(yao)(yao)物(wu)研(yan)(yan)发(fa)(fa)与(yu)审(shen)(shen)评(ping)(ping)的技(ji)(ji)术(shu)(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)(试行(xing))》等(deng)(deng)(deng)3个指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze);在(zai)支持(chi)抗肿(zhong)瘤药(yao)(yao)(yao)(yao)(yao)物(wu)研(yan)(yan)发(fa)(fa),进(jin)一步满足(zu)申请人(ren)对具体(ti)(ti)抗肿(zhong)瘤药(yao)(yao)(yao)(yao)(yao)物(wu)的个药(yao)(yao)(yao)(yao)(yao)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)需求方(fang)面(mian),发(fa)(fa)布了《抗肿(zhong)瘤药(yao)(yao)(yao)(yao)(yao)联合治疗(liao)(liao)临(lin)床(chuang)试验技(ji)(ji)术(shu)(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)》《注射(she)用(yong)曲妥(tuo)珠单(dan)抗生(sheng)(sheng)物(wu)类似药(yao)(yao)(yao)(yao)(yao)临(lin)床(chuang)试验指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)》等(deng)(deng)(deng)22个指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze);在(zai)提高仿(fang)制(zhi)(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang)(liang)(liang),推进(jin)仿(fang)制(zhi)(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)一致(zhi)性评(ping)(ping)价方(fang)面(mian),规范审(shen)(shen)评(ping)(ping)标(biao)准(zhun)(zhun)和(he)尺度,发(fa)(fa)布了《化(hua)学药(yao)(yao)(yao)(yao)(yao)品注射(she)剂(ji)仿(fang)制(zhi)(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang)(liang)(liang)和(he)疗(liao)(liao)效一致(zhi)性评(ping)(ping)价技(ji)(ji)术(shu)(shu)(shu)要求》《化(hua)学药(yao)(yao)(yao)(yao)(yao)品注射(she)剂(ji)(特(te)殊注射(she)剂(ji))仿(fang)制(zhi)(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang)(liang)(liang)和(he)疗(liao)(liao)效一致(zhi)性评(ping)(ping)价技(ji)(ji)术(shu)(shu)(shu)要求》等(deng)(deng)(deng)9个指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)。这些指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)覆盖新(xin)(xin)(xin)冠应急审(shen)(shen)评(ping)(ping)标(biao)准(zhun)(zhun)、儿童(tong)用(yong)药(yao)(yao)(yao)(yao)(yao)、中药(yao)(yao)(yao)(yao)(yao)民族药(yao)(yao)(yao)(yao)(yao)技(ji)(ji)术(shu)(shu)(shu)标(biao)准(zhun)(zhun)体(ti)(ti)系、抗肿(zhong)瘤药(yao)(yao)(yao)(yao)(yao)物(wu)研(yan)(yan)发(fa)(fa)及仿(fang)制(zhi)(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)研(yan)(yan)发(fa)(fa)等(deng)(deng)(deng)热点(dian)(dian)难点(dian)(dian)问题,持(chi)续完善(shan)药(yao)(yao)(yao)(yao)(yao)品技(ji)(ji)术(shu)(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)原(yuan)(yuan)则(ze)(ze)体(ti)(ti)系,有效推动药(yao)(yao)(yao)(yao)(yao)物(wu)研(yan)(yan)发(fa)(fa)创新(xin)(xin)(xin),不(bu)断优(you)化(hua)统一审(shen)(shen)评(ping)(ping)尺度,大力提升审(shen)(shen)评(ping)(ping)质(zhi)(zhi)量(liang)(liang)(liang)和(he)效率,显著减少审(shen)(shen)评(ping)(ping)自由裁量(liang)(liang)(liang)权。

 八、持续(xu)深化药品审评(ping)审批制(zhi)度改革

(一(yi))加快境外已上市临床急需新(xin)药审(shen)评

深(shen)入贯彻国务院常务会议(yi)精神,落(luo)实加快境外(wai)已上(shang)市临(lin)床急需(xu)(xu)新药(yao)(yao)审评要求(qiu),在(zai)确定(ding)了(le)第一(yi)二批74个品(pin)种(zhong)名单的基(ji)础上(shang),国家药(yao)(yao)监(jian)(jian)局、国家卫(wei)生(sheng)健康委组(zu)织(zhi)有(you)关专家研究论证,遴选(xuan)临(lin)床急需(xu)(xu)新药(yao)(yao)品(pin)种(zhong),药(yao)(yao)审中心发布(bu)了(le)第三批7个品(pin)种(zhong)名单。对(dui)于(yu)符合《国家药(yao)(yao)品(pin)监(jian)(jian)督管理局 国家卫(wei)生(sheng)健康委员会关于(yu)临(lin)床急需(xu)(xu)境外(wai)新药(yao)(yao)审评审批相关事宜的公告》(2018年第79号)规定(ding)情(qing)形的品(pin)种(zhong),国家药(yao)(yao)监(jian)(jian)局会同国家卫(wei)生(sheng)健康委已组(zu)织(zhi)进(jin)行(xing)了(le)充分(fen)遴选(xuan),基(ji)本解决了(le)临(lin)床急需(xu)(xu)境外(wai)已上(shang)市新药(yao)(yao)在(zai)我国上(shang)市速度(du)较(jiao)慢(man)的问题,进(jin)一(yi)步提高了(le)公众用(yong)药(yao)(yao)的可及性。

2020年(nian),药审(shen)(shen)(shen)中(zhong)心完成了(le)13个(ge)(ge)用于治疗罕见病(bing)的(de)(de)、临(lin)床急(ji)需的(de)(de)药品(pin)的(de)(de)技术审(shen)(shen)(shen)评,均在规(gui)定(ding)时(shi)限内(nei)(nei)完成,罕见病(bing)药品(pin)在3个(ge)(ge)月(yue)之内(nei)(nei)完成审(shen)(shen)(shen)评,其他临(lin)床急(ji)需药品(pin)在6个(ge)(ge)月(yue)之内(nei)(nei)完成审(shen)(shen)(shen)评,大大缩短了(le)临(lin)床急(ji)需境(jing)外新(xin)(xin)药在我国(guo)上市的(de)(de)时(shi)间差(cha)距。截至2020年(nian)12月(yue)31日,已(yi)发布的(de)(de)三批81个(ge)(ge)品(pin)种(zhong)临(lin)床急(ji)需境(jing)外已(yi)上市新(xin)(xin)药中(zhong),已(yi)有38家企业(ye)的(de)(de)48个(ge)(ge)品(pin)种(zhong)提(ti)出注(zhu)册申请,其中(zhong)39个(ge)(ge)品(pin)种(zhong)已(yi)获批上市或完成审(shen)(shen)(shen)评,100%在时(shi)限内(nei)(nei)完成审(shen)(shen)(shen)评工(gong)作,详见附件7。

(二(er))加(jia)速(su)推动仿(fang)制药一致性评价工作

2020年,药审中心采取切实有效措施加速推进仿制(zhi)药一致性评价工作。

一(yi)(yi)(yi)(yi)是在口服(fu)固体(ti)制(zhi)剂(ji)(ji)一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)工(gong)(gong)作的(de)(de)(de)基础上,积(ji)极(ji)推进注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji)一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)工(gong)(gong)作。国家药(yao)(yao)监局于5月12日(ri)发布(bu)《关于开展化学药(yao)(yao)品注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji)仿(fang)(fang)制(zhi)药(yao)(yao)质量和(he)(he)疗(liao)(liao)效一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)工(gong)(gong)作的(de)(de)(de)公(gong)告》(2020年第62号(hao)),正式启动注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji)一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)工(gong)(gong)作。药(yao)(yao)审(shen)中心(xin)发布(bu)《化学药(yao)(yao)品注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji)仿(fang)(fang)制(zhi)药(yao)(yao)质量和(he)(he)疗(liao)(liao)效一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)技(ji)术要求(qiu)(qiu)》《化学药(yao)(yao)品注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji)仿(fang)(fang)制(zhi)药(yao)(yao)质量和(he)(he)疗(liao)(liao)效一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)申报(bao)资(zi)料要求(qiu)(qiu)》和(he)(he)《化学药(yao)(yao)品注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji)(特殊(shu)注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji))仿(fang)(fang)制(zhi)药(yao)(yao)质量和(he)(he)疗(liao)(liao)效一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)技(ji)术要求(qiu)(qiu)》等技(ji)术要求(qiu)(qiu)。针对正式启动前已(yi)有620件待审(shen)评(ping)的(de)(de)(de)注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji)一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)申请,药(yao)(yao)审(shen)中心(xin)成立专项审(shen)评(ping)工(gong)(gong)作组,采取细化分类处理措施(shi),严格执(zhi)行一(yi)(yi)(yi)(yi)次性(xing)(xing)发补(bu),明确(que)注(zhu)(zhu)(zhu)(zhu)射剂(ji)(ji)一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)注(zhu)(zhu)(zhu)(zhu)册检查的(de)(de)(de)随机原则,加快审(shen)评(ping)速(su)度,在不到5个月的(de)(de)(de)时间内(nei)完成了(le)620件品种的(de)(de)(de)审(shen)评(ping),一(yi)(yi)(yi)(yi)致(zhi)(zhi)(zhi)性(xing)(xing)评(ping)价(jia)按时限审(shen)评(ping)已(yi)进入常(chang)态化。

二是继续规(gui)(gui)范参比(bi)(bi)制(zhi)剂(ji)(ji)遴(lin)选工(gong)(gong)作(zuo),强(qiang)化服(fu)务与指导(dao)。药审中(zhong)心发布(bu)《化学仿制(zhi)药参比(bi)(bi)制(zhi)剂(ji)(ji)遴(lin)选申请资料要求》(药审中(zhong)心通(tong)告2020年(nian)第(di)32号),进(jin)(jin)一步强(qiang)调申请人的自查(cha)环节,提高参比(bi)(bi)制(zhi)剂(ji)(ji)遴(lin)选工(gong)(gong)作(zuo)效率。通(tong)过进(jin)(jin)一步规(gui)(gui)范内部(bu)审核、专家委员(yuan)会(hui)审核等流程,2020年(nian)优化了参比(bi)(bi)制(zhi)剂(ji)(ji)遴(lin)选工(gong)(gong)作(zuo)。自2017年(nian)8月开展一致性评价工(gong)(gong)作(zuo)以来共发布(bu)参比(bi)(bi)制(zhi)剂(ji)(ji)目录35批,涉及3963个品(pin)规(gui)(gui)(1703个品(pin)种),其中(zhong)包括注射剂(ji)(ji)参比(bi)(bi)制(zhi)剂(ji)(ji)975个品(pin)规(gui)(gui)(405个品(pin)种)。

三是加强(qiang)信息公开和培(pei)训(xun)。2020年7月举办线上化学仿(fang)制药注(zhu)射(she)剂(ji)一(yi)致性评价技(ji)术研讨(tao)会,对(dui)注(zhu)射(she)剂(ji)一(yi)致性评价技(ji)术要(yao)求、特殊注(zhu)射(she)剂(ji)技(ji)术要(yao)求、参比制剂(ji)申请资料(liao)要(yao)求等进行宣讲(jiang)。

四(si)是(shi)持续推进(jin)生物(wu)等(deng)效(xiao)性试验备(bei)案(an)(an)工作。2020年化(hua)学药生物(wu)等(deng)效(xiao)性试验备(bei)案(an)(an)平台(tai)共收(shou)集(ji)了672条记录,仿制药一致性评价生物(wu)等(deng)效(xiao)性试验备(bei)案(an)(an)平台(tai)共收(shou)集(ji)了292条记录。

(三)全(quan)面(mian)落实临床(chuang)试(shi)验期(qi)间风险管理

为落实(shi)《药(yao)(yao)品管(guan)(guan)理(li)法》《药(yao)(yao)品注(zhu)册管(guan)(guan)理(li)办法》中(zhong)有(you)关(guan)临(lin)(lin)床试(shi)(shi)验(yan)(yan)期(qi)(qi)(qi)间安(an)(an)全(quan)(quan)(quan)风(feng)险管(guan)(guan)理(li)工作(zuo),药(yao)(yao)审(shen)中(zhong)心(xin)在国家药(yao)(yao)监(jian)局指导下,发布了《药(yao)(yao)物临(lin)(lin)床试(shi)(shi)验(yan)(yan)期(qi)(qi)(qi)间安(an)(an)全(quan)(quan)(quan)信息评估与管(guan)(guan)理(li)规范(fan)(试(shi)(shi)行(xing))》、《研发期(qi)(qi)(qi)间安(an)(an)全(quan)(quan)(quan)性(xing)更新(xin)报告管(guan)(guan)理(li)规范(fan)(试(shi)(shi)行(xing))》和《药(yao)(yao)物临(lin)(lin)床试(shi)(shi)验(yan)(yan)登记(ji)及信息公(gong)示管(guan)(guan)理(li)规范(fan)(试(shi)(shi)行(xing))》3个配套文件(jian)。为进(jin)一步加强临(lin)(lin)床试(shi)(shi)验(yan)(yan)过程的安(an)(an)全(quan)(quan)(quan)信息监(jian)测、识别(bie)、评估和风(feng)险控(kong)制,制定了《药(yao)(yao)品审(shen)评中(zhong)心(xin)药(yao)(yao)物临(lin)(lin)床试(shi)(shi)验(yan)(yan)期(qi)(qi)(qi)间安(an)(an)全(quan)(quan)(quan)信息评估与风(feng)险管(guan)(guan)理(li)工作(zuo)程序(试(shi)(shi)行(xing))》,上(shang)线运行(xing)“临(lin)(lin)床试(shi)(shi)验(yan)(yan)期(qi)(qi)(qi)间安(an)(an)全(quan)(quan)(quan)风(feng)险管(guan)(guan)理(li)系(xi)统”,对临(lin)(lin)床试(shi)(shi)验(yan)(yan)期(qi)(qi)(qi)间的安(an)(an)全(quan)(quan)(quan)信息,如可(ke)疑且非(fei)预期(qi)(qi)(qi)严(yan)重不良反应(SUSAR)和研发期(qi)(qi)(qi)间安(an)(an)全(quan)(quan)(quan)性(xing)更新(xin)报告(DSUR)等开(kai)展全(quan)(quan)(quan)过程信息系(xi)统化的风(feng)险评估。

2020年药(yao)审中(zhong)(zhong)心接(jie)收来自(zi)国(guo)内外(wai)的(de)(de)SUSAR个(ge)例(li)报告164403份(fen)(涉及病(bing)(bing)例(li)为(wei)57995例(li))。其中(zhong)(zhong),来自(zi)中(zhong)(zhong)国(guo)的(de)(de)SUSAR个(ge)例(li)报告17243份(fen)(涉及病(bing)(bing)例(li)为(wei)4647例(li));接(jie)收DSUR共计1775份(fen);完成(cheng)临(lin)(lin)(lin)床(chuang)试验(yan)登记(ji)2610项(含(han)新(xin)冠(guan)病(bing)(bing)毒疫苗和新(xin)冠(guan)肺炎治疗药(yao)物)。对18个(ge)药(yao)物临(lin)(lin)(lin)床(chuang)试验(yan)中(zhong)(zhong)存在的(de)(de)安全性风险,提出了进一(yi)步的(de)(de)风险控制处(chu)理(li)意见,包括一(yi)般(ban)风险控制(如修改临(lin)(lin)(lin)床(chuang)试验(yan)方案、修改知(zhi)情同意书、修改研究(jiu)者手册、补(bu)充完善风险控制措施(shi))和建议申请人主动暂停临(lin)(lin)(lin)床(chuang)试验(yan)等。

面对突如其来的(de)(de)严(yan)重(zhong)新(xin)冠(guan)肺炎(yan)疫(yi)情(qing),药审(shen)(shen)(shen)中(zhong)心(xin)探索建立(li)了(le)申请人进行临(lin)床(chuang)试(shi)(shi)验进展(zhan)信(xin)息报告机制与通(tong)道,规范了(le)相(xiang)关工(gong)作(zuo)程序与技(ji)术要求,发布了(le)《新(xin)冠(guan)肺炎(yan)疫(yi)情(qing)期间(jian)药物(wu)(wu)临(lin)床(chuang)试(shi)(shi)验管理指导原则(试(shi)(shi)行)》,制定了(le)规范统一的(de)(de)《应(ying)急(ji)审(shen)(shen)(shen)批(pi)品种临(lin)床(chuang)试(shi)(shi)验进展(zhan)和安(an)全(quan)(quan)监(jian)(jian)(jian)测(ce)(ce)工(gong)作(zuo)文件》。通(tong)过每日和每周的(de)(de)动(dong)态(tai)风险沟通(tong)交流,实施有(you)效的(de)(de)风险监(jian)(jian)(jian)测(ce)(ce)与风险控制。对2020年2月2日至2020年12月31日经特(te)别审(shen)(shen)(shen)批(pi)程序批(pi)准15个(ge)疫(yi)苗、16个(ge)生物(wu)(wu)制品、6个(ge)化学药、2个(ge)中(zhong)药的(de)(de)临(lin)床(chuang)试(shi)(shi)验共39个(ge)品种实施动(dong)态(tai)安(an)全(quan)(quan)监(jian)(jian)(jian)测(ce)(ce),完成(cheng)了(le)应(ying)急(ji)审(shen)(shen)(shen)批(pi)新(xin)冠(guan)病(bing)毒疫(yi)苗及(ji)新(xin)冠(guan)肺炎(yan)治疗药物(wu)(wu)临(lin)床(chuang)试(shi)(shi)验进展(zhan)及(ji)安(an)全(quan)(quan)性监(jian)(jian)(jian)测(ce)(ce)报告共195份。

药(yao)审中心(xin)参加《药(yao)物警戒质量(liang)管理规范》(GVP)的起(qi)草工(gong)作,撰写临(lin)床(chuang)试验(yan)期(qi)间(jian)(jian)药(yao)物警戒相关内容和要求(qiu)。完(wan)成《临(lin)床(chuang)试验(yan)期(qi)间(jian)(jian)安全(quan)信息管理:国际医学科(ke)学组织理事会(CIOMS)VI工(gong)作组报(bao)告》的翻译与出版(ban)工(gong)作,召开“疫情期(qi)间(jian)(jian)临(lin)床(chuang)试验(yan)管理及远(yuan)(yuan)程智(zhi)能技术应用学术交(jiao)流视频会议”,探索开展远(yuan)(yuan)程智(zhi)能化临(lin)床(chuang)试验(yan)的安全(quan)管理工(gong)作,稳(wen)步提升(sheng)临(lin)床(chuang)试验(yan)期(qi)间(jian)(jian)安全(quan)信息评估(gu)和风(feng)险管理能力(li)。

(四(si))继续夯实审评(ping)科学基础建设

1.审评(ping)质量(liang)管理体系建设(she)

发(fa)挥审(shen)(shen)评(ping)(ping)质量(liang)管(guan)(guan)理体(ti)系对(dui)药(yao)(yao)品(pin)(pin)审(shen)(shen)评(ping)(ping)工(gong)作(zuo)(zuo)(zuo)持(chi)续(xu)有效运(yun)行的(de)保障作(zuo)(zuo)(zuo)用(yong)。一方面(mian)是(shi)应对(dui)新法律规章实施对(dui)审(shen)(shen)评(ping)(ping)业务(wu)工(gong)作(zuo)(zuo)(zuo)带来的(de)风险和(he)(he)挑战(zhan),结(jie)合《药(yao)(yao)品(pin)(pin)注(zhu)册(ce)管(guan)(guan)理办法》及其配套文(wen)件要求,及时(shi)组织对(dui)《质量(liang)手册(ce)》等体(ti)系文(wen)件进行全面(mian)修订,加强药(yao)(yao)品(pin)(pin)审(shen)(shen)评(ping)(ping)业务(wu)与(yu)质量(liang)体(ti)系的(de)结(jie)合;另一方面(mian)是(shi)应对(dui)新冠(guan)肺炎疫情(qing)对(dui)审(shen)(shen)评(ping)(ping)工(gong)作(zuo)(zuo)(zuo)带来的(de)影(ying)响,通过开展药(yao)(yao)审(shen)(shen)中心(xin)(xin)专项内部监(jian)督检查,充分(fen)锻炼(lian)药(yao)(yao)审(shen)(shen)中心(xin)(xin)内审(shen)(shen)员(yuan)队伍,及时(shi)发(fa)现存在的(de)风险并(bing)组织改进;同时(shi)持(chi)续(xu)开展年度(du)(du)满意度(du)(du)调(diao)查工(gong)作(zuo)(zuo)(zuo),收集国家药(yao)(yao)监(jian)局和(he)(he)申请(qing)人对(dui)药(yao)(yao)审(shen)(shen)中心(xin)(xin)在落实新注(zhu)册(ce)相关要求、应对(dui)新冠(guan)肺炎疫情(qing)风险防控时(shi)的(de)意见(jian)和(he)(he)建议,为(wei)提高审(shen)(shen)评(ping)(ping)质量(liang)和(he)(he)效率(lv)提供(gong)思路,发(fa)挥质量(liang)体(ti)系对(dui)各项工(gong)作(zuo)(zuo)(zuo)的(de)支持(chi)作(zuo)(zuo)(zuo)用(yong)。

2.强化审评信息化建设

为确保(bao)各项(xiang)审(shen)(shen)评(ping)(ping)改革工(gong)作(zuo)(zuo)(zuo)执行过程中的(de)规范化(hua)(hua)(hua)(hua)(hua)、标准化(hua)(hua)(hua)(hua)(hua)、数字化(hua)(hua)(hua)(hua)(hua),药(yao)审(shen)(shen)中心(xin)大力推(tui)进信息(xi)化(hua)(hua)(hua)(hua)(hua)建设,依据《药(yao)品(pin)(pin)注(zhu)册管理(li)(li)(li)办法》和流程为导向的(de)科学管理(li)(li)(li)体系(xi),以药(yao)品(pin)(pin)审(shen)(shen)评(ping)(ping)业务流程为基(ji)础,立足工(gong)作(zuo)(zuo)(zuo)实际,对药(yao)品(pin)(pin)技术审(shen)(shen)评(ping)(ping)系(xi)统升(sheng)级(ji)完(wan)善。新增发(fa)补前(qian)的(de)专业审(shen)(shen)评(ping)(ping)问(wen)询和发(fa)补后(hou)的(de)补充资料问(wen)询平(ping)台,优(you)化(hua)(hua)(hua)(hua)(hua)沟(gou)通交(jiao)流系(xi)统,加强审(shen)(shen)评(ping)(ping)期(qi)间与申请(qing)人(ren)的(de)主动(dong)沟(gou)通交(jiao)流,促进审(shen)(shen)评(ping)(ping)业务工(gong)作(zuo)(zuo)(zuo)开(kai)展;新增异(yi)议处理(li)(li)(li)审(shen)(shen)核和注(zhu)册检(jian)验网(wang)(wang)络(luo)通道,调整优(you)先(xian)审(shen)(shen)评(ping)(ping)审(shen)(shen)批系(xi)统,强化(hua)(hua)(hua)(hua)(hua)审(shen)(shen)核流程可操作(zuo)(zuo)(zuo)性,保(bao)障审(shen)(shen)评(ping)(ping)审(shen)(shen)批工(gong)作(zuo)(zuo)(zuo)顺利实施。开(kai)通受(shou)(shou)理(li)(li)(li)网(wang)(wang)上(shang)预约通道,减少人(ren)员流动(dong)聚集(ji),有效(xiao)保(bao)障新冠肺(fei)炎疫情期(qi)间申请(qing)人(ren)受(shou)(shou)理(li)(li)(li)业务的(de)有序办理(li)(li)(li);增加突破性治疗药(yao)物(wu)程序,为鼓励(li)创新和加快临床急(ji)需品(pin)(pin)种上(shang)市拓宽审(shen)(shen)评(ping)(ping)通道。通过信息(xi)化(hua)(hua)(hua)(hua)(hua)手(shou)段助力药(yao)品(pin)(pin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批业务管理(li)(li)(li),强化(hua)(hua)(hua)(hua)(hua)网(wang)(wang)络(luo)信息(xi)安全保(bao)障,不(bu)断(duan)提升(sheng)药(yao)品(pin)(pin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批工(gong)作(zuo)(zuo)(zuo)质(zhi)量和效(xiao)率。目(mu)前(qian)药(yao)审(shen)(shen)中心(xin)网(wang)(wang)站(zhan)申请(qing)人(ren)之窗实名(ming)注(zhu)册申请(qing)企业10674家,基(ji)本实现了药(yao)品(pin)(pin)、原(yuan)料药(yao)、辅料、包材注(zhu)册申请(qing)人(ren)网(wang)(wang)上(shang)业务办理(li)(li)(li)的(de)全覆(fu)盖(gai)。

(五)积极推(tui)进流程导向科学(xue)管(guan)理体系建设

为贯彻党的(de)(de)(de)(de)(de)十九届四中(zhong)、五(wu)中(zhong)全(quan)会(hui)精神(shen),加(jia)强治(zhi)理(li)体系(xi)、治(zhi)理(li)能力(li)建(jian)设,以(yi)流程(cheng)导向科(ke)学(xue)(xue)管理(li)体系(xi)建(jian)设为抓手,不(bu)断推(tui)进药(yao)品审(shen)(shen)(shen)(shen)(shen)评体系(xi)和审(shen)(shen)(shen)(shen)(shen)评能力(li)的(de)(de)(de)(de)(de)现代(dai)化(hua)。按照前期(qi)工作计划(hua),药(yao)审(shen)(shen)(shen)(shen)(shen)中(zhong)心(xin)已全(quan)面铺开任务受理(li)、任务分配、专业审(shen)(shen)(shen)(shen)(shen)评、综合审(shen)(shen)(shen)(shen)(shen)评、沟通(tong)交流、专家咨询(xun)、书面发(fa)补、核查检验共8个子课题的(de)(de)(de)(de)(de)科(ke)学(xue)(xue)管理(li)体系(xi)试点建(jian)设,并(bing)印发(fa)《药(yao)审(shen)(shen)(shen)(shen)(shen)中(zhong)心(xin)关于运(yun)行药(yao)品专业审(shen)(shen)(shen)(shen)(shen)评流程(cheng)导向科(ke)学(xue)(xue)管理(li)体系(xi)有关问(wen)题的(de)(de)(de)(de)(de)通(tong)知》等8个文件(jian),制定科(ke)学(xue)(xue)管理(li)体系(xi)制度(du)(du)制修订计划(hua)(含(han)28项制度(du)(du)),截至2020年12月31日已完成(cheng)14项。注重试点建(jian)设成(cheng)果的(de)(de)(de)(de)(de)信息化(hua),将各(ge)项措施纳入审(shen)(shen)(shen)(shen)(shen)评信息系(xi)统,增强措施执行的(de)(de)(de)(de)(de)刚性约束,提高了(le)科(ke)学(xue)(xue)监管和智慧审(shen)(shen)(shen)(shen)(shen)评能力(li)。

形成按季度(du)汇报机制,定(ding)期组织汇报试(shi)点(dian)运行情况。建(jian)(jian)立了改(gai)革措(cuo)(cuo)(cuo)施管理(li)台账(zhang),纳入了58项需要监督(du)的改(gai)革措(cuo)(cuo)(cuo)施,按月度(du)对每项改(gai)革措(cuo)(cuo)(cuo)施实施的责任落实、进(jin)展情况、新问(wen)题和(he)解决建(jian)(jian)议予(yu)以一体化动态(tai)管理(li)。召开了试(shi)点(dian)推进(jin)座谈会(hui)、子课题结题座谈会(hui),对各子课题试(shi)点(dian)进(jin)度(du)、成效(xiao)(xiao)、问(wen)题等进(jin)行总结分析。建(jian)(jian)立了促进(jin)试(shi)点(dian)建(jian)(jian)设(she)的长效(xiao)(xiao)运行机制,常态(tai)化、一体化推进(jin)科(ke)学(xue)审评、高效(xiao)(xiao)审评和(he)廉(lian)洁审评。

(六)持(chi)续开展ICH工作

切实(shi)推(tui)进我国药(yao)(yao)(yao)(yao)(yao)品审(shen)评(ping)审(shen)批体(ti)系(xi)与国际接轨(gui),参(can)与ICH指导原(yuan)(yuan)(yuan)则(ze)的国际协调。一是(shi)(shi)积极参(can)与ICH议(yi)题协调工(gong)(gong)作(zuo),自原(yuan)(yuan)(yuan)国家(jia)食(shi)品药(yao)(yao)(yao)(yao)(yao)品监督管理总局(ju)2017年(nian)加入ICH以来(lai),已向36个(ge)ICH工(gong)(gong)作(zuo)组(zu)(zu)派出了(le)69名(ming)专家(jia),2020年(nian)参(can)与ICH工(gong)(gong)作(zuo)组(zu)(zu)电话(hua)会437场。二是(shi)(shi)进一步推(tui)进ICH三级(ji)指导原(yuan)(yuan)(yuan)则(ze)实(shi)施工(gong)(gong)作(zuo),国家(jia)药(yao)(yao)(yao)(yao)(yao)监局(ju)共(gong)发(fa)布了(le)3个(ge)ICH指导原(yuan)(yuan)(yuan)则(ze)适(shi)(shi)用及(ji)推(tui)荐适(shi)(shi)用公(gong)告。三是(shi)(shi)组(zu)(zu)织(zhi)开展ICH指导原(yuan)(yuan)(yuan)则(ze)培训(xun)工(gong)(gong)作(zuo),药(yao)(yao)(yao)(yao)(yao)审(shen)中(zhong)心开展ICH指导原(yuan)(yuan)(yuan)则(ze)线上(shang)培训(xun)共(gong)15场,主要(yao)围(wei)绕(rao)29个(ge)ICH指导原(yuan)(yuan)(yuan)则(ze)的技术要(yao)点、实(shi)施现状、实(shi)施过程中(zhong)可(ke)能存在的问题等内容(rong)进行宣贯。培训(xun)对象主要(yao)包括国家(jia)药(yao)(yao)(yao)(yao)(yao)监局(ju)相关(guan)司局(ju)、各直属(shu)单(dan)位、各省级(ji)药(yao)(yao)(yao)(yao)(yao)监局(ju)和省级(ji)药(yao)(yao)(yao)(yao)(yao)检机构的相关(guan)工(gong)(gong)作(zuo)人(ren)员,共(gong)计2723人(ren)观看培训(xun)直播,4244人(ren)观看直播回放。四(si)是(shi)(shi)召开ICH指导原(yuan)(yuan)(yuan)则(ze)和协调议(yi)题研讨会,为广泛听(ting)取行业及(ji)学界(jie)专家(jia)意见,2020年(nian)药(yao)(yao)(yao)(yao)(yao)审(shen)中(zhong)心共(gong)召开ICH国内专家(jia)研讨会15场,共(gong)计312人(ren)参(can)会。

(七)加强审评队伍(wu)建(jian)设和管(guan)理(li)

加强审评队伍建设(she),畅通(tong)审评员(yuan)职业发展(zhan)通(tong)道,开展(zhan)主审审评员(yuan)认定(ding)工作;完善聘(pin)期考核(he)评价体系,加强员(yuan)工聘(pin)期考核(he)工作;开展(zhan)补充性招(zhao)聘(pin),引进临(lin)床、统计等紧缺专业人才(cai);加强员(yuan)工培(pei)训,组织开展(zhan)《药品注册(ce)管(guan)理办法》及配套文件(jian)系列讲(jiang)座、实训、英语(yu)口语(yu)等培(pei)训。

  九、加强服务指导、改进(jin)工作效率和作风

2020年,药(yao)审中心驰而不(bu)息强化作风建设,积极服务药(yao)品(pin)高质量(liang)发展新要(yao)求。

一(yi)是(shi)紧密围绕新(xin)冠(guan)肺炎(yan)(yan)疫(yi)(yi)(yi)情(qing)防(fang)控大局,超常(chang)规创(chuang)新(xin)开展(zhan)应(ying)(ying)急(ji)审(shen)评(ping)审(shen)批(pi),加强审(shen)评(ping)服(fu)务保障,全力(li)做好新(xin)冠(guan)病(bing)毒疫(yi)(yi)(yi)苗(miao)审(shen)评(ping)过程中(zhong)的(de)(de)各(ge)项工作。面对新(xin)冠(guan)肺炎(yan)(yan)疫(yi)(yi)(yi)情(qing)对新(xin)冠(guan)病(bing)毒疫(yi)(yi)(yi)苗(miao)药(yao)物的(de)(de)急(ji)迫需(xu)(xu)求(qiu),药(yao)审(shen)中(zhong)心坚持(chi)(chi)尊重(zhong)科学规律,建立早期介入,持(chi)(chi)续跟(gen)踪,主动(dong)服(fu)务、研审(shen)联动(dong)的(de)(de)工作机制,始终保持(chi)(chi)24小时(shi)(shi)与企业(ye)畅(chang)通沟通的(de)(de)状态(tai),无论多(duo)晚,即(ji)使是(shi)凌晨3-4点钟,都会第一(yi)时(shi)(shi)间(jian)反馈研发企业(ye)诉求(qiu),在(zai)推动(dong)境(jing)外临(lin)(lin)床试(shi)(shi)(shi)验上(shang)强化担(dan)当,在(zai)创(chuang)新(xin)审(shen)评(ping)审(shen)批(pi)中(zhong)挖潜增效(xiao),成(cheng)(cheng)功高效(xiao)推动(dong)国(guo)药(yao)集(ji)团新(xin)冠(guan)病(bing)毒疫(yi)(yi)(yi)苗(miao)附条件批(pi)准上(shang)市和(he)(he)(he)5个疫(yi)(yi)(yi)苗(miao)品种(zhong)进入Ⅲ期临(lin)(lin)床试(shi)(shi)(shi)验,确(que)保中(zhong)国(guo)新(xin)冠(guan)病(bing)毒疫(yi)(yi)(yi)苗(miao)走在(zai)世界(jie)前列(lie),及时(shi)(shi)有(you)力(li)支撑(cheng)了(le)(le)疫(yi)(yi)(yi)情(qing)防(fang)控大局。同时(shi)(shi)贯彻落实(shi)习近平(ping)总书记坚持(chi)(chi)中(zhong)西(xi)医结合、中(zhong)西(xi)药(yao)并用的(de)(de)重(zhong)要(yao)指示精神,主动(dong)对接(jie)临(lin)(lin)床救治中(zhong)应(ying)(ying)用的(de)(de)“三药(yao)三方”生产(chan)企业(ye)和(he)(he)(he)研发单位,积极(ji)做好有(you)效(xiao)中(zhong)药(yao)方剂转化产(chan)品注册和(he)(he)(he)临(lin)(lin)床试(shi)(shi)(shi)验申请技术指导(dao),确(que)保中(zhong)药(yao)第一(yi)时(shi)(shi)间(jian)用于新(xin)冠(guan)肺炎(yan)(yan)患者救治。这些成(cheng)(cheng)果(guo)不仅(jin)(jin)确(que)保了(le)(le)防(fang)疫(yi)(yi)(yi)的(de)(de)应(ying)(ying)急(ji)所需(xu)(xu),还为常(chang)态(tai)化疫(yi)(yi)(yi)情(qing)防(fang)控准备了(le)(le)重(zhong)要(yao)的(de)(de)战(zhan)略(lve)资源,不仅(jin)(jin)提振了(le)(le)国(guo)人(ren)战(zhan)胜疫(yi)(yi)(yi)情(qing)的(de)(de)信(xin)心,还为全球疫(yi)(yi)(yi)情(qing)防(fang)控贡献了(le)(le)中(zhong)国(guo)力(li)量。

二是强(qiang)化(hua)服务(wu)(wu)(wu)申(shen)(shen)请(qing)(qing)人(ren)(ren)(ren)沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)。在新(xin)(xin)冠(guan)肺(fei)炎疫情(qing)防控(kong)常态化(hua)的(de)(de)情(qing)况(kuang)下,全面落实新(xin)(xin)冠(guan)肺(fei)炎疫情(qing)联防联控(kong)措施(shi),最(zui)大限度减少人(ren)(ren)(ren)员流(liu)(liu)动聚集,阻断疫情(qing)传播扩(kuo)散(san)渠(qu)道(dao),切实保障申(shen)(shen)请(qing)(qing)人(ren)(ren)(ren)的(de)(de)生命安(an)全和(he)(he)(he)(he)身体健(jian)康(kang),暂(zan)停现场咨(zi)询业务(wu)(wu)(wu)的(de)(de)同时开通(tong)(tong)(tong)(tong)(tong)(tong)(tong)了(le)电(dian)话咨(zi)询业务(wu)(wu)(wu)。增设立了(le)8个(ge)联系邮(you)箱,申(shen)(shen)请(qing)(qing)人(ren)(ren)(ren)可以邮(you)件(jian)咨(zi)询问题并(bing)提供在审品种(zhong)受理(li)(li)(li)号等信息(xi),项目管(guan)理(li)(li)(li)人(ren)(ren)(ren)员将在3个(ge)工作(zuo)日内与(yu)该受理(li)(li)(li)号相关的(de)(de)申(shen)(shen)请(qing)(qing)人(ren)(ren)(ren)进(jin)行联系。通(tong)(tong)(tong)(tong)(tong)(tong)(tong)过(guo)不断丰富和(he)(he)(he)(he)拓展沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)的(de)(de)渠(qu)道(dao)和(he)(he)(he)(he)方式,服务(wu)(wu)(wu)和(he)(he)(he)(he)便(bian)利申(shen)(shen)请(qing)(qing)人(ren)(ren)(ren);为(wei)(wei)鼓励创新(xin)(xin),更好地体现沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)的(de)(de)服务(wu)(wu)(wu)属性,结合《药(yao)(yao)品注(zhu)(zhu)册管(guan)理(li)(li)(li)办(ban)(ban)法(fa)》,从药(yao)(yao)物(wu)研制规律和(he)(he)(he)(he)注(zhu)(zhu)册要求(qiu)出发,秉持(chi)为(wei)(wei)药(yao)(yao)品注(zhu)(zhu)册申(shen)(shen)请(qing)(qing)人(ren)(ren)(ren)服务(wu)(wu)(wu)的(de)(de)原(yuan)则,修订后发布了(le)《药(yao)(yao)物(wu)研发与(yu)技(ji)术审评沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)管(guan)理(li)(li)(li)办(ban)(ban)法(fa)》。在保证(zheng)受试者安(an)全性的(de)(de)基础(chu)上,将Ⅱ类(lei)会议(yi)划分为(wei)(wei)依法(fa)应沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)、原(yuan)则上应当沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)、可以沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)三类(lei)情(qing)形,并(bing)明确和(he)(he)(he)(he)细化(hua)了(le)三类(lei)沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)的(de)(de)情(qing)形和(he)(he)(he)(he)要求(qiu);为(wei)(wei)提高(gao)沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)申(shen)(shen)请(qing)(qing)办(ban)(ban)理(li)(li)(li)的(de)(de)可预见性和(he)(he)(he)(he)效率(lv),药(yao)(yao)审中(zhong)心通(tong)(tong)(tong)(tong)(tong)(tong)(tong)过(guo)持(chi)续(xu)优化(hua)沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)管(guan)理(li)(li)(li),细化(hua)环节时限控(kong)制,确保了(le)申(shen)(shen)请(qing)(qing)人(ren)(ren)(ren)能够(gou)尽快(kuai)享受到(dao)优质的(de)(de)沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)服务(wu)(wu)(wu),努力满足申(shen)(shen)请(qing)(qing)人(ren)(ren)(ren)逐(zhu)年增加的(de)(de)沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)需求(qiu),将2020年沟(gou)(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)(jiao)流(liu)(liu)申(shen)(shen)请(qing)(qing)办(ban)(ban)理(li)(li)(li)量提升至(zhi)2019年办(ban)(ban)理(li)(li)(li)量的(de)(de)1.31倍,这也是2016年办(ban)(ban)理(li)(li)(li)量的(de)(de)11.35倍。

三是(shi)持(chi)续(xu)改(gai)善内部工作作风,提(ti)(ti)(ti)高工作效率。这(zhei)一(yi)年药(yao)(yao)审(shen)(shen)(shen)(shen)中(zhong)心继续(xu)深(shen)化审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)制度(du)改(gai)革,持(chi)续(xu)优化审(shen)(shen)(shen)(shen)评(ping)(ping)流程,严格时(shi)限管理(li),实(shi)施(shi)审(shen)(shen)(shen)(shen)评(ping)(ping)任(ren)务分析会(hui)制度(du),加强项目(mu)(mu)督导,鼓(gu)励药(yao)(yao)品(pin)(pin)创新,推动仿(fang)制药(yao)(yao)高质量(liang)发展(zhan)(zhan),审(shen)(shen)(shen)(shen)评(ping)(ping)质量(liang)和(he)效率有了极大地提(ti)(ti)(ti)升(sheng),2020年全年审(shen)(shen)(shen)(shen)结任(ren)务整体按时(shi)完成(cheng)率创历史新高。药(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)的可(ke)预期性进一(yi)步提(ti)(ti)(ti)高,顺(shun)利完成(cheng)《十(shi)三五(wu)药(yao)(yao)品(pin)(pin)安全规划》涉及药(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)改(gai)革目(mu)(mu)标。通(tong)过(guo)5年来深(shen)化药(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批(pi)制度(du)改(gai)革的不懈努(nu)力,药(yao)(yao)审(shen)(shen)(shen)(shen)中(zhong)心实(shi)现了量(liang)变到质变的飞跃,药(yao)(yao)品(pin)(pin)平均审(shen)(shen)(shen)(shen)评(ping)(ping)时(shi)限大幅压缩,审(shen)(shen)(shen)(shen)评(ping)(ping)能力大幅提(ti)(ti)(ti)升(sheng),一(yi)大批(pi)创新药(yao)(yao)、临(lin)床急需药(yao)(yao)获批(pi)上市,累计通(tong)过(guo)和(he)视(shi)同(tong)通(tong)过(guo)一(yi)致(zhi)性评(ping)(ping)价(jia)审(shen)(shen)(shen)(shen)评(ping)(ping)的品(pin)(pin)种(zhong)已达(da)445个,为十(shi)四五(wu)药(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)事业的发展(zhan)(zhan)奠定了坚实(shi)的基础。

药审(shen)(shen)中心将深入梳(shu)理在提(ti)高(gao)审(shen)(shen)评(ping)效(xiao)率、创新(xin)审(shen)(shen)评(ping)方(fang)(fang)式等(deng)方(fang)(fang)面的经验做法(fa),使应急状(zhuang)态(tai)(tai)下的临时性措(cuo)施,有序地上升(sheng)为常态(tai)(tai)化(hua)审(shen)(shen)评(ping)工作长(zhang)效(xiao)机制(zhi),将被(bei)动选择(ze)但被(bei)实践证明长(zhang)期有效(xiao)的方(fang)(fang)法(fa)转化(hua)为常态(tai)(tai)化(hua)条件下提(ti)高(gao)审(shen)(shen)评(ping)能力的主(zhu)动选择(ze)。

十、加大(da)药品(pin)审评审批信息公(gong)开力度

药审(shen)(shen)中心持续(xu)推进(jin)技术审(shen)(shen)评(ping)的(de)(de)(de)信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)工(gong)作,提高(gao)药品审(shen)(shen)评(ping)审(shen)(shen)批工(gong)作透(tou)明(ming)度(du)(du)。一(yi)是(shi)完善信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)制度(du)(du),发布了《药品审(shen)(shen)评(ping)审(shen)(shen)批信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)管理办法》,明(ming)确信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)的(de)(de)(de)范围(wei)、种类、时(shi)限等要求,为(wei)做(zuo)好信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)工(gong)作提供了制度(du)(du)依(yi)据。二是(shi)大力(li)推动新(xin)药技术审(shen)(shen)评(ping)报告的(de)(de)(de)公(gong)(gong)开(kai)(kai)(kai)(kai)(kai),自开(kai)(kai)(kai)(kai)(kai)展工(gong)作以来已完成(cheng)公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)新(xin)药技术审(shen)(shen)评(ping)报告316个,指导行业(ye)研发,更好的(de)(de)(de)服务药品注(zhu)册申(shen)(shen)请(qing)人和公(gong)(gong)众。三是(shi)加大技术审(shen)(shen)评(ping)过程信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)力(li)度(du)(du),通(tong)(tong)过药审(shen)(shen)中心网站(zhan)向申(shen)(shen)请(qing)人进(jin)一(yi)步公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)了审(shen)(shen)评(ping)排队信(xin)(xin)(xin)息(xi)、优先审(shen)(shen)评(ping)的(de)(de)(de)状(zhuang)态信(xin)(xin)(xin)息(xi)、沟通(tong)(tong)交流(liu)申(shen)(shen)请(qing)及办理信(xin)(xin)(xin)息(xi)等信(xin)(xin)(xin)息(xi),新(xin)增了“突(tu)破(po)性治疗(liao)公(gong)(gong)示”的(de)(de)(de)栏目,公(gong)(gong)开(kai)(kai)(kai)(kai)(kai)了“拟突(tu)破(po)性治疗(liao)品种、异议(yi)论(lun)证结果”等信(xin)(xin)(xin)息(xi)。方便(bian)申(shen)(shen)请(qing)人查(cha)询信(xin)(xin)(xin)息(xi),进(jin)一(yi)步拓宽了申(shen)(shen)请(qing)人的(de)(de)(de)沟通(tong)(tong)渠(qu)道,及时(shi)回应社会关切,提高(gao)了审(shen)(shen)评(ping)审(shen)(shen)批工(gong)作的(de)(de)(de)透(tou)明(ming)度(du)(du)。

 十一、2021年重点工作安排

2020年,药品审(shen)(shen)评(ping)(ping)工作(zuo)取得了一定进展,但(dan)仍存在(zai)着(zhe)一些问(wen)题(ti)(ti):一是注(zhu)册申请申报量,特别是创新(xin)药申报量连年递增,药审(shen)(shen)中(zhong)心(xin)审(shen)(shen)评(ping)(ping)队(dui)伍规模结构与(yu)审(shen)(shen)评(ping)(ping)任(ren)务量配比失衡;二是高层次(ci)及(ji)(ji)紧(jin)缺专(zhuan)业人才引(yin)进难、新(xin)进审(shen)(shen)评(ping)(ping)员急(ji)需长期专(zhuan)业培训等审(shen)(shen)评(ping)(ping)能力现代化短板问(wen)题(ti)(ti)突出(chu);三是新(xin)旧注(zhu)册相(xiang)关规定过渡(du)期间,应(ying)及(ji)(ji)时研究问(wen)题(ti)(ti),给(ji)予相(xiang)应(ying)的解(jie)决措(cuo)施。2021年药审(shen)(shen)中(zhong)心(xin)将紧(jin)密围绕国家药监局工作(zuo)部署,重点开展以下工作(zuo):

(一)积(ji)极推动制度(du)体系建设

完(wan)善新《药(yao)品(pin)注(zhu)册管理办法》配套(tao)文件,做好新旧(jiu)注(zhu)册相关(guan)(guan)规定(ding)过渡(du)期相关(guan)(guan)工作,稳妥处理历史问(wen)题;继续开展(zhan)药(yao)品(pin)审(shen)(shen)评流程导(dao)向科学(xue)管理体系(xi)(xi)(xi)建设(she)工作,构建长(zhang)效运行机制(zhi),完(wan)善药(yao)品(pin)技(ji)术指导(dao)原则体系(xi)(xi)(xi),规范中心制(zhi)度体系(xi)(xi)(xi)建设(she),推(tui)动审(shen)(shen)评体系(xi)(xi)(xi)和审(shen)(shen)评能力现(xian)代化;深入(ru)推(tui)进(jin)监管科学(xue)研究(jiu),深化与高校、科研院所合(he)作,加快首批重点(dian)项目研究(jiu)成果转化。

(二)毫不放松做好应急审评审批工作

始终保持应(ying)急工(gong)作(zuo)状态,完善(shan)研审(shen)(shen)联动机制(zhi),坚(jian)持特(te)事特(te)办(ban),促进(jin)包(bao)括中医药、抗(kang)体药物(wu)等新(xin)冠肺(fei)炎(yan)治(zhi)疗药物(wu)的研发;持续做好应(ying)急审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)核查检(jian)验(yan)协调工(gong)作(zuo);继续强化服(fu)务指导(dao),持续跟进(jin)各条技术路线新(xin)冠病毒疫(yi)苗(miao)研发进(jin)展,依(yi)法依(yi)规严格审(shen)(shen)评(ping)(ping),继续做好新(xin)冠肺(fei)炎(yan)治(zhi)疗药物(wu)和新(xin)冠病毒疫(yi)苗(miao)审(shen)(shen)评(ping)(ping)工(gong)作(zuo);全面总结应(ying)急审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)工(gong)作(zuo)经验(yan),完善(shan)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)制(zhi)度体系(xi),进(jin)一步激(ji)发药品(pin)创新(xin)发展活力。

(三)加(jia)快建立符合(he)中医药(yao)特点的(de)中药(yao)审评机制体系

构建中医(yi)药(yao)理(li)论(lun)、中药(yao)人用经(jing)验和(he)临床(chuang)试验“三结合”的审(shen)(shen)评(ping)证据体系,组建古(gu)代经(jing)典(dian)名(ming)方中药(yao)复方制剂专家审(shen)(shen)评(ping)委员会(hui),扎实推进中药(yao)审(shen)(shen)评(ping)审(shen)(shen)批(pi)改革;参(can)考(kao)“三方”审(shen)(shen)评(ping)审(shen)(shen)批(pi)经(jing)验,逐步探索(suo)适合古(gu)代经(jing)典(dian)名(ming)方的中药(yao)复方制剂的审(shen)(shen)评(ping)指(zhi)导原则(ze)和(he)标准,完善符合中医(yi)药(yao)特点的技术指(zhi)导原则(ze);加快确有临床(chuang)价值的中药(yao)新药(yao)审(shen)(shen)批(pi),发挥中医(yi)药(yao)在疾病防治中的独特优势。

(四)持续深化审评审批制(zhi)度改(gai)革

巩固按时(shi)限审(shen)(shen)(shen)评改(gai)革成(cheng)果,完善(shan)项目(mu)管理工作(zuo)机(ji)制;完善(shan)专(zhuan)家咨询委员会制度,解(jie)决争议重(zhong)大疑(yi)难问题,利用(yong)巡视整改(gai)要(yao)求(qiu)推动制度改(gai)革,加(jia)(jia)大审(shen)(shen)(shen)评审(shen)(shen)(shen)批(pi)信息公开力度,优化沟(gou)通(tong)交流制度,提高审(shen)(shen)(shen)评服务水平;细(xi)化上(shang)市(shi)(shi)药品(pin)变更管理技(ji)术要(yao)求(qiu),指导(dao)药品(pin)上(shang)市(shi)(shi)许可持(chi)有人开展(zhan)上(shang)市(shi)(shi)后持(chi)续(xu)研究(jiu);进一步(bu)加(jia)(jia)强临床试验期间安全性评价(jia)及药物警戒(jie)体系建设(she);持(chi)续(xu)推进ICH指导(dao)原则(ze)在国(guo)内转化实施;加(jia)(jia)快(kuai)审(shen)(shen)(shen)评数(shu)字化建设(she),推进eCTD系统使用(yong)。加(jia)(jia)快(kuai)推进研发生产主体信息库建设(she)。

(五)坚持鼓励药品(pin)研(yan)发创(chuang)新

持续(xu)完善(shan)药(yao)(yao)品(pin)审(shen)(shen)(shen)(shen)评审(shen)(shen)(shen)(shen)批(pi)制度(du)体系,坚持以安全(quan)有效为(wei)根本(ben)标准,优化(hua)(hua)审(shen)(shen)(shen)(shen)评资源配置,在创(chuang)新(xin)(xin)药(yao)(yao)审(shen)(shen)(shen)(shen)评中探索实(shi)施“提前(qian)介入(ru)”“研(yan)审(shen)(shen)(shen)(shen)联动(dong)”“平行(xing)检(jian)验”“前(qian)置检(jian)验”等方式;继续(xu)鼓励(li)新(xin)(xin)药(yao)(yao)好药(yao)(yao)研(yan)发创(chuang)新(xin)(xin),强化(hua)(hua)沟通(tong)交流,优先配置资源,进一步(bu)细化(hua)(hua)和实(shi)施突破性(xing)治疗(liao)药(yao)(yao)物、附条件批(pi)准、优先审(shen)(shen)(shen)(shen)评、特别审(shen)(shen)(shen)(shen)批(pi)等加(jia)快(kuai)审(shen)(shen)(shen)(shen)评程序,加(jia)快(kuai)临床急需(xu)境外新(xin)(xin)药(yao)(yao)、罕见病(bing)用(yong)药(yao)(yao)、儿童(tong)用(yong)药(yao)(yao)、重大传染病(bing)用(yong)药(yao)(yao)等上市速度(du)。

(六)推动仿制药(yao)高质量发展

持(chi)续完善仿(fang)制(zhi)(zhi)药(yao)参(can)比(bi)制(zhi)(zhi)剂遴选,坚持(chi)标准(zhun)(zhun)不降低的原(yuan)则,稳妥有序推(tui)进仿(fang)制(zhi)(zhi)药(yao)质(zhi)(zhi)量和(he)(he)疗效(xiao)一(yi)致性评(ping)价;进一(yi)步完善仿(fang)制(zhi)(zhi)药(yao)相关(guan)技(ji)术(shu)指导原(yuan)则和(he)(he)标准(zhun)(zhun)体系(xi)建设;以建立审(shen)(shen)评(ping)要点体系(xi)为基础,推(tui)动(dong)仿(fang)制(zhi)(zhi)药(yao)审(shen)(shen)评(ping)科学规(gui)范(fan)、标准(zhun)(zhun),提高仿(fang)制(zhi)(zhi)药(yao)审(shen)(shen)评(ping)质(zhi)(zhi)量和(he)(he)效(xiao)率。

(七)优化(hua)人才(cai)队(dui)伍建设

按照国家药监局(ju)统一(yi)部署,全力(li)指导和推进(jin)(jin)长三角(jiao)、大湾区两个分中心建(jian)设;以专(zhuan)业(ye)培训为抓手,进(jin)(jin)一(yi)步加(jia)强药品审评队(dui)(dui)伍(wu)能(neng)力(li)建(jian)设;配合药品审评业(ye)务(wu),积(ji)极开展人员(yuan)招聘工(gong)作,加(jia)强队(dui)(dui)伍(wu)建(jian)设;进(jin)(jin)一(yi)步加(jia)强专(zhuan)业(ye)技(ji)术(shu)队(dui)(dui)伍(wu)建(jian)设,完(wan)善专(zhuan)业(ye)技(ji)术(shu)队(dui)(dui)伍(wu)晋升等制度;进(jin)(jin)一(yi)步严(yan)格人员(yuan)招聘条件,规范人员(yuan)离职,严(yan)格队(dui)(dui)伍(wu)管(guan)理。

 十二、结语

大(da)鹏(peng)一日同风起(qi),扶(fu)摇直(zhi)上(shang)九万里。2021年(nian)是(shi)实(shi)施(shi)“十(shi)四五”规划的(de)开局(ju)之年(nian),药(yao)(yao)(yao)审中(zhong)心(xin)将在国(guo)(guo)家药(yao)(yao)(yao)监局(ju)的(de)坚(jian)强领导下,坚(jian)持以(yi)习(xi)近(jin)平新时代中(zhong)国(guo)(guo)特色社会(hui)主义思(si)想(xiang)为(wei)指导,全面贯(guan)彻党(dang)(dang)的(de)十(shi)九大(da)和十(shi)九届二中(zhong)、三中(zhong)、四中(zhong)、五中(zhong)全会(hui)精(jing)神,坚(jian)持以(yi)人民为(wei)中(zhong)心(xin)的(de)发(fa)(fa)展(zhan)(zhan)思(si)想(xiang),按照立(li)(li)足新发(fa)(fa)展(zhan)(zhan)阶段(duan),贯(guan)彻新发(fa)(fa)展(zhan)(zhan)理念,构建新发(fa)(fa)展(zhan)(zhan)格局(ju)的(de)要(yao)求(qiu),以(yi)习(xi)近(jin)平总(zong)书记“四个最严”要(yao)求(qiu)为(wei)根本(ben)遵循,以(yi)鼓励创新推动药(yao)(yao)(yao)品(pin)(pin)高质量发(fa)(fa)展(zhan)(zhan)为(wei)主题,以(yi)深化(hua)药(yao)(yao)(yao)品(pin)(pin)审评审批(pi)制度(du)改革为(wei)主线,以(yi)满足人民日益增长(zhang)的(de)美好(hao)生活需要(yao)为(wei)根本(ben)目的(de),以(yi)建设国(guo)(guo)际化(hua)现(xian)代化(hua)科学化(hua)药(yao)(yao)(yao)品(pin)(pin)审评机构为(wei)根本(ben)动力,坚(jian)持为(wei)国(guo)(guo)为(wei)民履(lv)职尽(jin)责,切实(shi)保障药(yao)(yao)(yao)品(pin)(pin)安全有效可(ke)及(ji),保护和促进公众(zhong)健康,努(nu)力实(shi)现(xian)“十(shi)四五”时期发(fa)(fa)展(zhan)(zhan)开好(hao)局(ju)、起(qi)好(hao)步,以(yi)优(you)异成(cheng)绩迎接(jie)中(zhong)国(guo)(guo)共产党(dang)(dang)成(cheng)立(li)(li)100周年(nian)。

 

 

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来源:国家药品(pin)监督管(guan)理局网(wang)站,具(ju)体详见(jian):http://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20210621142436183.html