2020年度药品审评报告

时间:2020-06-22

2020年(nian)是极不(bu)平凡的(de)一年(nian),面对突如其(qi)来的(de)新(xin)(xin)(xin)(xin)冠(guan)肺炎疫(yi)情(qing),国家(jia)(jia)药(yao)(yao)品(pin)(pin)监(jian)(jian)督(du)管(guan)(guan)理(li)局(ju)(ju)药(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)中心(以下简称药(yao)(yao)审(shen)(shen)(shen)(shen)(shen)(shen)中心)在国家(jia)(jia)药(yao)(yao)品(pin)(pin)监(jian)(jian)督(du)管(guan)(guan)理(li)局(ju)(ju)(以下简称国家(jia)(jia)药(yao)(yao)监(jian)(jian)局(ju)(ju))的(de)坚强领导下,认真(zhen)学习贯彻习近平总书记(ji)重要讲(jiang)话(hua)和重要指示批示精神,闻(wen)令而动、尽锐出(chu)战,坚持(chi)人(ren)民(min)至上(shang)(shang)、生命至上(shang)(shang),超常规建立(li)“早期介入、持(chi)续跟踪、主动服务、研(yan)审(shen)(shen)(shen)(shen)(shen)(shen)联动”全天候应急审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)审(shen)(shen)(shen)(shen)(shen)(shen)批工作机(ji)制(zhi),加(jia)速推动新(xin)(xin)(xin)(xin)冠(guan)病毒疫(yi)苗(miao)和新(xin)(xin)(xin)(xin)冠(guan)肺炎治疗(liao)药(yao)(yao)物研(yan)发上(shang)(shang)市,充分发挥技术审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)对疫(yi)情(qing)防(fang)控的(de)科(ke)技支撑作用;主动服务于药(yao)(yao)监(jian)(jian)系统工作大局(ju)(ju),紧(jin)紧(jin)围绕(rao)落实(shi)党(dang)中央国务院(yuan)审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)审(shen)(shen)(shen)(shen)(shen)(shen)批制(zhi)度(du)改革、贯彻《药(yao)(yao)品(pin)(pin)管(guan)(guan)理(li)法》《疫(yi)苗(miao)管(guan)(guan)理(li)法》《药(yao)(yao)品(pin)(pin)注(zhu)册管(guan)(guan)理(li)办法》、推动审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)体系和审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)能(neng)力(li)现代化(hua),统筹推进(jin)疫(yi)情(qing)防(fang)控和依法依规科(ke)学审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)工作,不(bu)断(duan)提(ti)(ti)高审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)质(zhi)量和效率(lv),不(bu)断(duan)加(jia)快新(xin)(xin)(xin)(xin)药(yao)(yao)研(yan)发上(shang)(shang)市步伐,为疫(yi)情(qing)防(fang)控和满足临(lin)床急需提(ti)(ti)供有效药(yao)(yao)物保(bao)障(zhang)(zhang)、为医药(yao)(yao)产业(ye)(ye)高质(zhi)量发展提(ti)(ti)供有力(li)促(cu)进(jin)作用,保(bao)障(zhang)(zhang)了人(ren)民(min)群众用药(yao)(yao)安全有效可及,药(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)(shen)(shen)评(ping)(ping)(ping)事业(ye)(ye)得(de)到新(xin)(xin)(xin)(xin)发展、迈上(shang)(shang)新(xin)(xin)(xin)(xin)台阶、开创(chuang)新(xin)(xin)(xin)(xin)局(ju)(ju)面。 

一、药品注册申请审(shen)评审(shen)批情况

(一(yi))总体(ti)完成情(qing)况

1.全年审评审批完成情况(kuang)

2020年(nian)(nian),根据《药(yao)品(pin)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)管(guan)(guan)理办(ban)(ban)法》(国家(jia)市场监(jian)督管(guan)(guan)理总(zong)局令第27号(hao))、《国家(jia)药(yao)监(jian)局关(guan)于实施<药(yao)品(pin)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)管(guan)(guan)理办(ban)(ban)法>有关(guan)事宜(yi)的(de)公告》(2020年(nian)(nian)第46号(hao),以(yi)下(xia)(xia)简称46号(hao)公告)及《药(yao)品(pin)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)管(guan)(guan)理办(ban)(ban)法》相关(guan)配套文件(jian)(jian)(jian)(jian),药(yao)审中(zhong)(zhong)(zhong)心完成(cheng)中(zhong)(zhong)(zhong)药(yao)(包括(kuo)民族药(yao),下(xia)(xia)同(tong)(tong)(tong))、化学药(yao)、生物制品(pin)各类(lei)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)(qing)审评(ping)审批共11582件(jian)(jian)(jian)(jian)(含(han)(han)器械组(zu)合产品(pin)4件(jian)(jian)(jian)(jian),以(yi)受理号(hao)计,下(xia)(xia)同(tong)(tong)(tong)),较2019年(nian)(nian)增长32.67%(如无说明,以(yi)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)(qing)件(jian)(jian)(jian)(jian)数计,下(xia)(xia)同(tong)(tong)(tong))。其中(zhong)(zhong)(zhong),完成(cheng)需(xu)技(ji)(ji)术审评(ping)的(de)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)(qing)8606件(jian)(jian)(jian)(jian)(含(han)(han)5674件(jian)(jian)(jian)(jian)需(xu)药(yao)审中(zhong)(zhong)(zhong)心技(ji)(ji)术审评(ping)和(he)行政(zheng)审批注(zhu)(zhu)(zhu)册(ce)(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)(qing)),较2019年(nian)(nian)增长26.24%;完成(cheng)直(zhi)接行政(zheng)审批(无需(xu)技(ji)(ji)术审评(ping),下(xia)(xia)同(tong)(tong)(tong))的(de)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)(qing)2972件(jian)(jian)(jian)(jian)。2020年(nian)(nian)底正在审评(ping)审批和(he)等待审评(ping)审批的(de)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)(qing)已由2015年(nian)(nian)9月高(gao)峰时(shi)的(de)近22000件(jian)(jian)(jian)(jian)降至4882件(jian)(jian)(jian)(jian)(不含(han)(han)完成(cheng)技(ji)(ji)术审评(ping)因申(shen)(shen)(shen)报资料缺陷等待申(shen)(shen)(shen)请(qing)(qing)(qing)人回复补充资料的(de)注(zhu)(zhu)(zhu)册(ce)(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)(qing))。

完成8606件需技术(shu)审(shen)评(ping)(ping)的药(yao)品(pin)注(zhu)(zhu)(zhu)册(ce)申请中,化学药(yao)注(zhu)(zhu)(zhu)册(ce)申请为(wei)6778件,较(jiao)(jiao)2019年(nian)(nian)增(zeng)(zeng)长(zhang)25.22%;中药(yao)注(zhu)(zhu)(zhu)册(ce)申请418件,较(jiao)(jiao)2019年(nian)(nian)增(zeng)(zeng)长(zhang)39.33%;生物(wu)制(zhi)品(pin)注(zhu)(zhu)(zhu)册(ce)申请1410件,较(jiao)(jiao)2019年(nian)(nian)增(zeng)(zeng)长(zhang)27.72%;化学药(yao)注(zhu)(zhu)(zhu)册(ce)申请约占全部技术(shu)审(shen)评(ping)(ping)完成量的78.76%。2016-2020年(nian)(nian)中药(yao)、生物(wu)制(zhi)品(pin)、化学药(yao)注(zhu)(zhu)(zhu)册(ce)申请审(shen)评(ping)(ping)审(shen)批完成情况详见图(tu)1。

 

 

  药(yao)审(shen)(shen)中(zhong)心完(wan)成(cheng)(cheng)需技术审(shen)(shen)评(ping)(ping)的(de)8606件(jian)(jian)注(zhu)册申(shen)请(qing)中(zhong),完(wan)成(cheng)(cheng)新药(yao)临床试验(IND)申(shen)请(qing)审(shen)(shen)评(ping)(ping)1561件(jian)(jian),较2019年(nian)增长55.94%;完(wan)成(cheng)(cheng)新药(yao)上市申(shen)请(qing)(NDA)审(shen)(shen)评(ping)(ping)289件(jian)(jian),完(wan)成(cheng)(cheng)仿制药(yao)上市申(shen)请(qing)(ANDA)审(shen)(shen)评(ping)(ping)1700件(jian)(jian);完(wan)成(cheng)(cheng)仿制药(yao)质量和(he)疗效一致(zhi)性评(ping)(ping)价(以下简称一致(zhi)性评(ping)(ping)价)申(shen)请(qing)(以补充申(shen)请(qing)途径(jing)申(shen)报(bao))1136件(jian)(jian),较2019年(nian)增长103.22%;完(wan)成(cheng)(cheng)补充申(shen)请(qing)技术审(shen)(shen)评(ping)(ping)3250件(jian)(jian),较2019年(nian)增长24.19%。2016-2020年(nian)各(ge)类(lei)注(zhu)册申(shen)请(qing)审(shen)(shen)评(ping)(ping)完(wan)成(cheng)(cheng)情(qing)况详见图2。

 

3.审(shen)评通(tong)过情况(kuang)

2020年,药(yao)审(shen)(shen)中心审(shen)(shen)评(ping)(ping)(ping)通过(guo)(guo)批(pi)准IND申(shen)请(qing)1435件(jian),较2019年增(zeng)长(zhang)54.97%;审(shen)(shen)评(ping)(ping)(ping)通过(guo)(guo)NDA 208件(jian),较2019年增(zeng)长(zhang)26.83%;审(shen)(shen)评(ping)(ping)(ping)通过(guo)(guo)ANDA 918件(jian);审(shen)(shen)评(ping)(ping)(ping)通过(guo)(guo)批(pi)准一致性评(ping)(ping)(ping)价申(shen)请(qing)577件(jian),较2019年增(zeng)长(zhang)121.92%。

药审(shen)(shen)中心审(shen)(shen)评(ping)通(tong)过创新药NDA 20个品种(zhong),审(shen)(shen)评(ping)通(tong)过境外生产原研(yan)药品NDA 72个品种(zhong)(含(han)新增(zeng)适(shi)应症(zheng)品种(zhong)),具体品种(zhong)详见附(fu)件(jian)1、2。

4.审结注册申请任务(wu)按时限(xian)完成情况

2020年,药审(shen)(shen)(shen)中心持(chi)续优(you)化(hua)审(shen)(shen)(shen)评(ping)流程,严(yan)格审(shen)(shen)(shen)评(ping)时(shi)(shi)限管理(li),加强项目督导,加快审(shen)(shen)(shen)评(ping)速度,整(zheng)体审(shen)(shen)(shen)评(ping)任(ren)务(wu)和(he)重点(dian)序列审(shen)(shen)(shen)评(ping)任(ren)务(wu)按(an)(an)(an)(an)时(shi)(shi)限完成率(lv)均取得显著(zhu)提升(sheng)。全年审(shen)(shen)(shen)结注册申请(qing)任(ren)务(wu)整(zheng)体按(an)(an)(an)(an)时(shi)(shi)限完成率(lv)为(wei)94.48%,其中临床急需境外已上市新药注册申请(qing)审(shen)(shen)(shen)结任(ren)务(wu)整(zheng)体按(an)(an)(an)(an)时(shi)(shi)限完成率(lv)为(wei)100%,按(an)(an)(an)(an)默(mo)示许(xu)可受(shou)理(li)注册申请(qing)的审(shen)(shen)(shen)结任(ren)务(wu)整(zheng)体按(an)(an)(an)(an)时(shi)(shi)限完成率(lv)为(wei)99.87%,直接行政审(shen)(shen)(shen)批的注册申请(qing)100%在法定的20个工作日内完成,且审(shen)(shen)(shen)批平(ping)均用时(shi)(shi)11.8个工作日。各类注册申请(qing)任(ren)务(wu)按(an)(an)(an)(an)时(shi)(shi)限完成情况详见表1。

 

  2020年(nian)的(de)NDA年(nian)度整体按(an)时(shi)(shi)限(xian)(xian)(xian)完(wan)(wan)成(cheng)率已经有了很大的(de)提(ti)升(sheng),例如:NDA按(an)时(shi)(shi)限(xian)(xian)(xian)完(wan)(wan)成(cheng)率在(zai)(zai)2020年(nian)12月(yue)突破(po)80%,提(ti)升(sheng)至(zhi)87.5%;ANDA按(an)时(shi)(shi)限(xian)(xian)(xian)完(wan)(wan)成(cheng)率在(zai)(zai)2020年(nian)12月(yue)突破(po)90%,达到93.85%;纳入(ru)优先审评程序的(de)注册申请按(an)时(shi)(shi)限(xian)(xian)(xian)完(wan)(wan)成(cheng)率在(zai)(zai)2020年(nian)10-12月(yue)的(de)月(yue)度按(an)时(shi)(shi)限(xian)(xian)(xian)完(wan)(wan)成(cheng)率连(lian)续达到90%以上(shang),取得历史(shi)性突破(po)。

(二)中药注册(ce)申请(qing)审(shen)评完成情况(kuang)

1.总(zong)体情况

2020年,药审中(zhong)(zhong)心完成(cheng)审评的中(zhong)(zhong)药注册申(shen)(shen)请(qing)418件(jian)。其中(zhong)(zhong),完成(cheng)IND申(shen)(shen)请(qing)37件(jian),完成(cheng)NDA 8件(jian),完成(cheng)ANDA 3件(jian)。2020年中(zhong)(zhong)药各(ge)类注册申(shen)(shen)请(qing)的审评完成(cheng)情况(kuang)详(xiang)见图3。

 

2.审(shen)评通过情况

药(yao)(yao)(yao)审(shen)中心审(shen)评通(tong)过(guo)批准中药(yao)(yao)(yao)IND申(shen)请28件(jian),审(shen)评通(tong)过(guo)中药(yao)(yao)(yao)NDA 4件(jian)(连(lian)花清咳片、筋骨止痛凝胶、桑枝总(zong)生(sheng)物(wu)碱片及桑枝总(zong)生(sheng)物(wu)碱)。2020年(nian)中药(yao)(yao)(yao)各类(lei)注(zhu)册申(shen)请审(shen)评完成的具体情况详见(jian)表2,2016-2020年(nian)审(shen)评通(tong)过(guo)批准中药(yao)(yao)(yao)IND申(shen)请和审(shen)评通(tong)过(guo)中药(yao)(yao)(yao)NDA情况详见(jian)图(tu)4。

 

 

  药审中(zhong)心审评通过批(pi)准(zhun)(zhun)的(de)中(zhong)药IND申(shen)请28件(jian),涉及10个适应症领(ling)域。其中(zhong),呼吸7件(jian)、骨(gu)科(ke)4件(jian)、消(xiao)化(hua)4件(jian),共占53.57%,2020年审评通过批(pi)准(zhun)(zhun)的(de)中(zhong)药IND申(shen)请适应症分布详见图5。

 

(三)化学药注册申请(qing)审(shen)评完成情况(kuang)

1.总体情况

2020年(nian),药审中心(xin)完(wan)成(cheng)(cheng)审评(ping)的化(hua)(hua)学(xue)(xue)药注册申(shen)请(qing)6778件(jian)。其(qi)中,完(wan)成(cheng)(cheng)化(hua)(hua)学(xue)(xue)药临(lin)床申(shen)请(qing)(IND申(shen)请(qing)和验证(zheng)性临(lin)床)共1086件(jian),较2019年(nian)增长(zhang)(zhang)45.58%;完(wan)成(cheng)(cheng)化(hua)(hua)学(xue)(xue)药NDA 163件(jian);完(wan)成(cheng)(cheng)化(hua)(hua)学(xue)(xue)药ANDA 1697件(jian);完(wan)成(cheng)(cheng)一致(zhi)性评(ping)价申(shen)请(qing)1136件(jian),较2019年(nian)增长(zhang)(zhang)103.22%;完(wan)成(cheng)(cheng)化(hua)(hua)学(xue)(xue)药补充申(shen)请(qing)2248件(jian),较2019年(nian)增长(zhang)(zhang)23.72%。2020年(nian)化(hua)(hua)学(xue)(xue)药各(ge)类注册申(shen)请(qing)的审评(ping)完(wan)成(cheng)(cheng)情(qing)况详见图6。

 

2.审评(ping)通(tong)过(guo)情(qing)况(kuang)

药审(shen)(shen)(shen)中(zhong)心完成(cheng)审(shen)(shen)(shen)评(ping)(ping)的化学(xue)药注册申请(qing)中(zhong),审(shen)(shen)(shen)评(ping)(ping)通过批准IND申请(qing)907件,较2019年(nian)(nian)增长(zhang)51.42%;审(shen)(shen)(shen)评(ping)(ping)通过NDA 115件,较2019年(nian)(nian)增长(zhang)30.68%;审(shen)(shen)(shen)评(ping)(ping)通过ANDA 918件,较2019年(nian)(nian)增长(zhang)15.33%。2020年(nian)(nian)化学(xue)药各类(lei)注册申请(qing)审(shen)(shen)(shen)评(ping)(ping)完成(cheng)的具(ju)体情况详见表3。

 

药(yao)审(shen)中(zhong)心(xin)完成(cheng)审(shen)评的化(hua)学(xue)(xue)药(yao)IND申请960件,审(shen)评通过(guo)批准(zhun)IND申请907件。其中(zhong),1类创(chuang)新(xin)化(hua)学(xue)(xue)药(yao)IND申请694件(298个(ge)品(pin)(pin)种(zhong)),较2019年增长40.77%,品(pin)(pin)种(zhong)数(shu)较2019年增长57.67%。2016-2020年审(shen)评通过(guo)批准(zhun)化(hua)学(xue)(xue)药(yao)IND申请、1类创(chuang)新(xin)化(hua)学(xue)(xue)药(yao)IND申请情况详见图7。

 

药(yao)审中心审评(ping)通过批(pi)准(zhun)IND申请的(de)694件1类创(chuang)新(xin)化学药(yao)中,抗肿瘤药(yao)物、抗感(gan)染(ran)药(yao)物、循环系(xi)统(tong)疾(ji)病(bing)药(yao)物、内分(fen)泌系(xi)统(tong)药(yao)物、消化系(xi)统(tong)疾(ji)病(bing)药(yao)物和风湿性疾(ji)病(bing)及(ji)免疫药(yao)物较多,占全部创(chuang)新(xin)药(yao)临床试验批(pi)准(zhun)数(shu)量的(de)80.69%。2020年审评(ping)通过批(pi)准(zhun)的(de)1类创(chuang)新(xin)化学药(yao)IND申请适应症分(fen)布(bu)详见图(tu)8。

 

药(yao)(yao)审(shen)(shen)(shen)中心完成审(shen)(shen)(shen)评(ping)的化(hua)学药(yao)(yao)NDA共(gong)163件(jian)。其中,审(shen)(shen)(shen)评(ping)通过化(hua)药(yao)(yao)NDA 115件(jian),审(shen)(shen)(shen)评(ping)通过1类(lei)创新化(hua)学药(yao)(yao)NDA 14个品种。2016-2020年审(shen)(shen)(shen)评(ping)通过化(hua)学药(yao)(yao)NDA情况详见图(tu)9。

 

  药审(shen)中心完成审(shen)评(ping)(ping)(ping)的一致性(xing)评(ping)(ping)(ping)价(jia)申请(qing)共(gong)1136件,审(shen)评(ping)(ping)(ping)通过577件。其中,审(shen)评(ping)(ping)(ping)通过批准口服(fu)固(gu)体(ti)制剂一致性(xing)评(ping)(ping)(ping)价(jia)456件,审(shen)评(ping)(ping)(ping)通过批准注射剂一致性(xing)评(ping)(ping)(ping)价(jia)申请(qing)121件,具体(ti)品种详(xiang)(xiang)见附(fu)件3。2018-2020年(nian)审(shen)评(ping)(ping)(ping)通过批准的一致性(xing)评(ping)(ping)(ping)价(jia)申请(qing)情况详(xiang)(xiang)见图10。

 

(四)生物(wu)制品注(zhu)册申(shen)请审评(ping)完成情况

1.总体情况

2020年,药审中(zhong)心完(wan)(wan)成(cheng)(cheng)审评(ping)的(de)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)制(zhi)品(pin)注册(ce)申(shen)(shen)(shen)请(qing)(qing)(qing)(qing)共1410件。其中(zhong),完(wan)(wan)成(cheng)(cheng)预防用生(sheng)(sheng)(sheng)物(wu)(wu)(wu)制(zhi)品(pin)IND申(shen)(shen)(shen)请(qing)(qing)(qing)(qing)(预防用IND申(shen)(shen)(shen)请(qing)(qing)(qing)(qing))27件,完(wan)(wan)成(cheng)(cheng)治疗(liao)(liao)用生(sheng)(sheng)(sheng)物(wu)(wu)(wu)制(zhi)品(pin)IND申(shen)(shen)(shen)请(qing)(qing)(qing)(qing)(治疗(liao)(liao)用IND申(shen)(shen)(shen)请(qing)(qing)(qing)(qing))537件,较2019年增长58.88%;完(wan)(wan)成(cheng)(cheng)预防用生(sheng)(sheng)(sheng)物(wu)(wu)(wu)制(zhi)品(pin)NDA(预防用NDA)9件,完(wan)(wan)成(cheng)(cheng)治疗(liao)(liao)用生(sheng)(sheng)(sheng)物(wu)(wu)(wu)制(zhi)品(pin)NDA(治疗(liao)(liao)用NDA)108件,完(wan)(wan)成(cheng)(cheng)体外(wai)诊断试剂NDA(体外(wai)诊断NDA)1件。2020年生(sheng)(sheng)(sheng)物(wu)(wu)(wu)制(zhi)品(pin)各类(lei)注册(ce)申(shen)(shen)(shen)请(qing)(qing)(qing)(qing)的(de)审评(ping)完(wan)(wan)成(cheng)(cheng)情况详(xiang)见图11。

 

2.审评(ping)通过情(qing)况

药审(shen)(shen)中(zhong)(zhong)心(xin)审(shen)(shen)评通过(guo)批准生(sheng)物(wu)制(zhi)品(pin)IND申(shen)(shen)(shen)请(qing)500件(jian)(jian),较(jiao)(jiao)(jiao)2019年(nian)增(zeng)(zeng)长(zhang)60.26%。其(qi)中(zhong)(zhong),预防用(yong)IND申(shen)(shen)(shen)请(qing)19件(jian)(jian);治疗用(yong)IND申(shen)(shen)(shen)请(qing)481件(jian)(jian),较(jiao)(jiao)(jiao)2019年(nian)增(zeng)(zeng)长(zhang)63.61%。审(shen)(shen)评通过(guo)生(sheng)物(wu)制(zhi)品(pin)NDA 89件(jian)(jian),较(jiao)(jiao)(jiao)2019年(nian)增(zeng)(zeng)长(zhang)20.27%。其(qi)中(zhong)(zhong),预防用(yong)NDA 7件(jian)(jian);治疗用(yong)NDA 81件(jian)(jian)(制(zhi)剂77件(jian)(jian)),较(jiao)(jiao)(jiao)2019年(nian)增(zeng)(zeng)长(zhang)19.12%;体外(wai)诊断(duan)NDA 1件(jian)(jian)。2020年(nian)生(sheng)物(wu)制(zhi)品(pin)各(ge)类注册申(shen)(shen)(shen)请(qing)审(shen)(shen)评完成的具体情况详(xiang)见(jian)表4,2016-2020年(nian)审(shen)(shen)评通过(guo)批准生(sheng)物(wu)制(zhi)品(pin)IND申(shen)(shen)(shen)请(qing)和审(shen)(shen)评通过(guo)NDA情况详(xiang)见(jian)图12。

 

 

药审(shen)中心审(shen)评(ping)(ping)通过批(pi)准生(sheng)物(wu)(wu)制(zhi)品IND申请500件(jian),2020年(nian)(nian)审(shen)评(ping)(ping)通过批(pi)准的(de)生(sheng)物(wu)(wu)制(zhi)品IND申请适(shi)应(ying)症(zheng)(zheng)分(fen)布详见图(tu)13。药审(shen)中心审(shen)评(ping)(ping)通过生(sheng)物(wu)(wu)制(zhi)品NDA 89件(jian),2020年(nian)(nian)审(shen)评(ping)(ping)通过的(de)生(sheng)物(wu)(wu)制(zhi)品NDA适(shi)应(ying)症(zheng)(zheng)分(fen)布详见图(tu)14。

 

 

(五)行政审批注册(ce)申请完成情况

1.总体情况

2020年,药(yao)审(shen)中(zhong)(zhong)心完(wan)成(cheng)中(zhong)(zhong)药(yao)、化学药(yao)、生物制(zhi)品各(ge)类注(zhu)(zhu)册(ce)(ce)申(shen)请(qing)行政(zheng)审(shen)批(pi)共8646件(jian),较2019年增长(zhang)44.51%。其中(zhong)(zhong),完(wan)成(cheng)审(shen)评(ping)审(shen)批(pi)的注(zhu)(zhu)册(ce)(ce)申(shen)请(qing)(临床(chuang)试验申(shen)请(qing)、一致(zhi)性评(ping)价申(shen)请(qing)、补(bu)充(chong)申(shen)请(qing)、境(jing)外生产药(yao)品再注(zhu)(zhu)册(ce)(ce)及(ji)复审(shen))5674件(jian),较2019年增长(zhang)39.24%;完(wan)成(cheng)直(zhi)接行政(zheng)审(shen)批(pi)的注(zhu)(zhu)册(ce)(ce)申(shen)请(qing)(无需技术(shu)审(shen)评(ping)的补(bu)充(chong)申(shen)请(qing)、临时进口申(shen)请(qing))2972件(jian),较2019年增长(zhang)55.77%。2020年中(zhong)(zhong)药(yao)、化学药(yao)、生物制(zhi)品各(ge)类注(zhu)(zhu)册(ce)(ce)申(shen)请(qing)行政(zheng)审(shen)批(pi)完(wan)成(cheng)情(qing)(qing)况见(jian)表5。2018-2020年行政(zheng)审(shen)批(pi)注(zhu)(zhu)册(ce)(ce)申(shen)请(qing)完(wan)成(cheng)情(qing)(qing)况详(xiang)见(jian)图15。

 

 

2.需审评(ping)审批的注册(ce)申请完成情况

药审中心(xin)完成(cheng)的需审评审批的5674件注册(ce)(ce)申请(qing)(qing)中,临床试验(yan)申请(qing)(qing)1686件(含验(yan)证性临床),较(jiao)(jiao)2019年(nian)增(zeng)长(zhang)(zhang)50.00%;一致性评价申请(qing)(qing)623件,较(jiao)(jiao)2019年(nian)增(zeng)长(zhang)(zhang)80.58%;补充申请(qing)(qing)2860件,较(jiao)(jiao)2019年(nian)增(zeng)长(zhang)(zhang)34.46%;境外生(sheng)产(chan)药品(pin)再(zai)注册(ce)(ce)478件、复审27件。

3.直接(jie)行政审批的注册申(shen)请完成情况

药(yao)审(shen)中(zhong)心完(wan)成直接行政(zheng)审(shen)批的(de)2972件(jian)(jian)(jian)注册申请中(zhong),按注册申请类型(xing)划分,补充申请2537件(jian)(jian)(jian)、临时进口(kou)申请435件(jian)(jian)(jian)。按药(yao)品类型(xing)划分,中(zhong)药(yao)153件(jian)(jian)(jian)、化学药(yao)2411件(jian)(jian)(jian)、生物制品408件(jian)(jian)(jian)。

(六(liu))注册申请(qing)不批(pi)准的主要原因及存在的问题

2020年,中药(yao)、化学药(yao)、生物制(zhi)品(pin)各类药(yao)品(pin)注册(ce)申请(qing)因(yin)申报资(zi)料(liao)无法证(zheng)明药(yao)品(pin)安全性(xing)、有效性(xing)或者质量可(ke)控性(xing),以及未能按期提交补充资(zi)料(liao)等情形,导(dao)致审评结论为建议不(bu)(bu)批准(zhun)(zhun)的(de)共367件(jian)。通过系统梳理上述注册(ce)申请(qing)不(bu)(bu)批准(zhun)(zhun)原因(yin),从新药(yao)、仿制(zhi)药(yao)等不(bu)(bu)同注册(ce)分类角度分析药(yao)品(pin)注册(ce)申请(qing)在研发和(he)申报过程中存在的(de)主(zhu)要问题包括:

1.新药(yao)申请

IND申请和研(yan)发中(zhong)存(cun)在的(de)问题主要有(you):正(zheng)式申报前未开(kai)展沟通(tong)交流(liu);开(kai)发立(li)题依(yi)据不(bu)足,成药(yao)性存(cun)在严(yan)重缺(que)陷;申报资料不(bu)足以(yi)支(zhi)持开(kai)展药(yao)物临(lin)(lin)床(chuang)试(shi)验(yan)或者(zhe)不(bu)能(neng)保障临(lin)(lin)床(chuang)受试(shi)者(zhe)安(an)全。具(ju)体(ti)表现包(bao)括:未沟通(tong)交流(liu)致(zhi)使申报后发现研(yan)究(jiu)信息(xi)严(yan)重缺(que)项,无(wu)法在时限内完(wan)成补充研(yan)究(jiu);已有(you)的(de)研(yan)究(jiu)结果提示(shi)药(yao)效作用弱,毒性大,临(lin)(lin)床(chuang)获(huo)益和风险(xian)(xian)比值(zhi)不(bu)合(he)理(li);临(lin)(lin)床(chuang)开(kai)发定位违背(bei)临(lin)(lin)床(chuang)诊疗、用药(yao)的(de)基本(ben)原则;已有(you)的(de)药(yao)学、临(lin)(lin)床(chuang)前研(yan)究(jiu)不(bu)符合(he)临(lin)(lin)床(chuang)试(shi)验(yan)要求;临(lin)(lin)床(chuang)试(shi)验(yan)方案整(zheng)体(ti)设计严(yan)重缺(que)陷,风险(xian)(xian)控制措施不(bu)足;联合(he)用药(yao)的(de)非临(lin)(lin)床(chuang)研(yan)究(jiu)数(shu)据不(bu)充分;联合(he)疫苗中(zhong)单苗的(de)数(shu)据不(bu)充分和/或免疫程序(xu)不(bu)一致(zhi)。

NDA研(yan)(yan)发(fa)(fa)和申报中(zhong)存在(zai)的(de)(de)问(wen)题(ti)主要有(you):研(yan)(yan)究(jiu)质(zhi)量(liang)(liang)控(kong)(kong)制和管(guan)理存在(zai)缺陷,导致已有(you)的(de)(de)研(yan)(yan)究(jiu)结果不能证明药品(pin)安(an)全(quan)性(xing)(xing)(xing)、有(you)效性(xing)(xing)(xing)和质(zhi)量(liang)(liang)可控(kong)(kong)性(xing)(xing)(xing);违反合(he)规性(xing)(xing)(xing)要求(qiu)。具体表现包(bao)括:关键临床研(yan)(yan)究(jiu)设计存在(zai)重(zhong)大缺陷,无法(fa)得出客观(guan)、有(you)力的(de)(de)有(you)效性(xing)(xing)(xing)、安(an)全(quan)性(xing)(xing)(xing)证据;药学(xue)研(yan)(yan)究(jiu)存在(zai)严重(zhong)缺陷,无法(fa)证明产品(pin)的(de)(de)质(zhi)量(liang)(liang)可控(kong)(kong)性(xing)(xing)(xing);各(ge)开发(fa)(fa)阶段的(de)(de)研(yan)(yan)究(jiu)受(shou)试样品(pin)不一致;注(zhu)册(ce)核查中(zhong)发(fa)(fa)现临床试验数据存在(zai)真实性(xing)(xing)(xing)问(wen)题(ti)。

2.仿(fang)制药申请

仿(fang)制(zhi)(zhi)药(yao)(yao)(yao)一(yi)致性(xing)(xing)(xing)评价申(shen)请(qing)和(he)上市申(shen)请(qing)中存在的(de)(de)问题主要有(you):仿(fang)制(zhi)(zhi)药(yao)(yao)(yao)研(yan)(yan)发立(li)题不合理;申(shen)报(bao)资料(liao)(liao)无法证明仿(fang)制(zhi)(zhi)药(yao)(yao)(yao)与参比制(zhi)(zhi)剂(ji)(被(bei)仿(fang)制(zhi)(zhi)药(yao)(yao)(yao)品(pin)(pin))的(de)(de)质量一(yi)致性(xing)(xing)(xing)。具(ju)(ju)体表现包括:仿(fang)制(zhi)(zhi)药(yao)(yao)(yao)的(de)(de)参比制(zhi)(zhi)剂(ji)已(yi)撤市,且已(yi)有(you)更新换代安全性(xing)(xing)(xing)更好的(de)(de)产品(pin)(pin)满足临(lin)床需求(qiu);样品(pin)(pin)复(fu)核(he)检(jian)验不符合规定(ding)或分析方法存在严(yan)重缺陷;人体生物(wu)等效性(xing)(xing)(xing)试验结(jie)果表明不等效;样品(pin)(pin)稳定(ding)性(xing)(xing)(xing)研(yan)(yan)究结(jie)果、原料(liao)(liao)药(yao)(yao)(yao)起始物(wu)料(liao)(liao)选择等不符合仿(fang)制(zhi)(zhi)药(yao)(yao)(yao)上市技(ji)术(shu)要求(qiu);仿(fang)制(zhi)(zhi)药(yao)(yao)(yao)未按规定(ding)使用具(ju)(ju)有(you)合法来源的(de)(de)原料(liao)(liao)药(yao)(yao)(yao)。

3.补(bu)充(chong)申请(qing)

补(bu)充申请(qing)研究(jiu)和申报中存在的(de)问题主要有:申请(qing)资(zi)料未能充分(fen)说(shuo)(shuo)明(ming)变更的(de)科学性(xing)和合(he)理性(xing),不(bu)足以支持变更事项;已有的(de)研究(jiu)结(jie)果不(bu)能保证变更后产品的(de)安全性(xing)、有效(xiao)性(xing)和质量可控性(xing)。具(ju)体(ti)表现包括:变更引起药用(yong)物质基础发生重大改变;药品说(shuo)(shuo)明(ming)书(shu)修改申请(qing)不(bu)符合(he)说(shuo)(shuo)明(ming)书(shu)撰写的(de)技术要求;用(yong)于支持变更的(de)文献资(zi)料存在偏倚,或者(zhe)临床安全性(xing)和有效(xiao)性(xing)数据不(bu)充分(fen)。

4.其他(ta)

其他(ta)药品(pin)注(zhu)册申(shen)请(qing)在(zai)(zai)研(yan)发和申(shen)报中(zhong)存在(zai)(zai)的问题主要有:生(sheng)物(wu)类似药开发缺少相似性比较(jiao)数据(ju),药学比对研(yan)究(jiu)中(zhong)参照药选择存在(zai)(zai)缺陷;生(sheng)物(wu)类似药临床前研(yan)究(jiu)结(jie)果不足以支持其开展临床试验(yan)(yan);天然(ran)药物(wu)的研(yan)究(jiu)资料不符合国(guo)际多中(zhong)心(xin)临床试验(yan)(yan)或我国(guo)天然(ran)药物(wu)评价基本技术要求。

(七)药品加快上市注册程序(xu)情况

创新是推(tui)动药(yao)(yao)品高(gao)质量(liang)发展(zhan)的(de)力量(liang)源泉,《药(yao)(yao)品注(zhu)册管理办(ban)法》结合我国(guo)医药(yao)(yao)产(chan)业发展(zhan)和(he)临(lin)床需求实(shi)际(ji),参考国(guo)际(ji)经验(yan),设立了(le)特别(bie)审(shen)(shen)批、突(tu)破性治疗药(yao)(yao)物(wu)、附条(tiao)件(jian)批准、优先审(shen)(shen)评(ping)审(shen)(shen)批四个药(yao)(yao)品加快(kuai)上(shang)(shang)市(shi)程(cheng)序。《国(guo)家药(yao)(yao)监局关(guan)于(yu)发布<突(tu)破性治疗药(yao)(yao)物(wu)审(shen)(shen)评(ping)工作程(cheng)序(试行)>等三个文(wen)件(jian)的(de)公告》(2020年第82号),明(ming)确了(le)加快(kuai)通道的(de)适用(yong)(yong)范(fan)围、适用(yong)(yong)条(tiao)件(jian)、工作程(cheng)序和(he)政(zheng)策支持等,既(ji)能(neng)显著提(ti)高(gao)相关(guan)程(cheng)序执行过程(cheng)中的(de)可(ke)操作性,鼓励(li)药(yao)(yao)物(wu)研制和(he)创新,又能(neng)在全球抗击疫(yi)情(qing)的(de)大(da)背景下,依(yi)法依(yi)规对疫(yi)情(qing)防(fang)控所需药(yao)(yao)物(wu)实(shi)行特别(bie)审(shen)(shen)批,对于(yu)加快(kuai)临(lin)床急需、临(lin)床价值突(tu)出(chu)、公共(gong)卫生急需等药(yao)(yao)物(wu)的(de)上(shang)(shang)市(shi)具有重要推(tui)动作用(yong)(yong)。2020年已批准上(shang)(shang)市(shi)药(yao)(yao)品纳(na)入加快(kuai)上(shang)(shang)市(shi)程(cheng)序情(qing)况详见附件(jian)4。

1.特别审批药物情况

在(zai)发(fa)生突(tu)(tu)发(fa)公共卫(wei)生事件的威胁(xie)时(shi)以(yi)及突(tu)(tu)发(fa)公共卫(wei)生事件发(fa)生后,国家(jia)药(yao)监(jian)局可依法决定(ding)对突(tu)(tu)发(fa)公共卫(wei)生事件应急(ji)所需(xu)防治药(yao)品实行特(te)别审批。纳(na)入实施特(te)别审批程序的药(yao)物,国家(jia)药(yao)监(jian)局按照统一指挥、早期介入、快速高效、科学审批的原则(ze),组(zu)织加(jia)快并同步(bu)开展药(yao)品注册(ce)受(shou)理、审评、核查、检验工(gong)作,并根据疾病防控的特(te)定(ding)需(xu)要,限定(ding)其在(zai)一定(ding)的期限和范围内使用。

2020年新(xin)冠肺(fei)炎疫(yi)情(qing)在全球范(fan)围内不断(duan)蔓延,人民群众(zhong)的(de)生(sheng)命安(an)全受到严重威(wei)胁,药(yao)审中心闻令而动,第一(yi)时间科(ke)学、高效推进(jin)特别(bie)审评工作(zuo),按程序将59件(jian)中药(yao)、化学药(yao)、生(sheng)物制品注册(ce)申(shen)请纳入(ru)特别(bie)审批(pi)程序并(bing)完成技术(shu)审评。建议附条(tiao)件(jian)批(pi)准上(shang)市(shi)1件(jian),为新(xin)型冠状病毒灭(mie)活(huo)疫(yi)苗(miao)(Vero细胞);建议批(pi)准临(lin)床试(shi)验(yan)申(shen)请53件(jian),其中5件(jian)已进(jin)入(ru)Ⅲ期(qi)临(lin)床试(shi)验(yan),批(pi)准化湿败毒颗(ke)粒(li)、清肺(fei)排(pai)毒颗(ke)粒(li)的(de)临(lin)床试(shi)验(yan)申(shen)请;批(pi)准了连花清瘟胶囊/颗(ke)粒(li)、金花清感颗(ke)粒(li)及血必(bi)净(jing)注射液等5件(jian)增加(jia)适应症的(de)补充申(shen)请,加(jia)速了新(xin)冠病毒疫(yi)苗(miao)和(he)新(xin)冠肺(fei)炎治(zhi)疗药(yao)物的(de)上(shang)市(shi)进(jin)程,初步(bu)满足了新(xin)冠肺(fei)炎疫(yi)情(qing)防控的(de)需(xu)要。

2.突破(po)性治疗(liao)药物情况

突破(po)(po)性(xing)(xing)治(zhi)(zhi)(zhi)(zhi)疗药(yao)(yao)(yao)(yao)物(wu)(wu)指(zhi)的(de)是(shi)用(yong)于(yu)防治(zhi)(zhi)(zhi)(zhi)严重危及生(sheng)命或(huo)者(zhe)严重影响生(sheng)存质(zhi)量(liang)的(de)疾病,且尚无有效防治(zhi)(zhi)(zhi)(zhi)手段或(huo)者(zhe)与现有治(zhi)(zhi)(zhi)(zhi)疗手段相(xiang)比有足够证据表明(ming)具(ju)有明(ming)显(xian)临(lin)床(chuang)优势(shi)的(de)创新药(yao)(yao)(yao)(yao)或(huo)者(zhe)改良(liang)型新药(yao)(yao)(yao)(yao)等,申(shen)(shen)请人可在Ⅰ、Ⅱ临(lin)床(chuang)试(shi)验(yan)阶段申(shen)(shen)请适用(yong)突破(po)(po)性(xing)(xing)治(zhi)(zhi)(zhi)(zhi)疗药(yao)(yao)(yao)(yao)物(wu)(wu)程序。根据《突破(po)(po)性(xing)(xing)治(zhi)(zhi)(zhi)(zhi)疗药(yao)(yao)(yao)(yao)物(wu)(wu)审(shen)评(ping)工作(zuo)程序(试(shi)行)》,纳入(ru)到(dao)“突破(po)(po)性(xing)(xing)治(zhi)(zhi)(zhi)(zhi)疗”审(shen)评(ping)通道的(de)药(yao)(yao)(yao)(yao)物(wu)(wu),药(yao)(yao)(yao)(yao)审(shen)中心一是(shi)会(hui)优先处理相(xiang)关(guan)沟通交流,加(jia)强(qiang)指(zhi)导并促进药(yao)(yao)(yao)(yao)物(wu)(wu)研(yan)发进程;二是(shi)在申(shen)(shen)报上(shang)市(shi)环节,该药(yao)(yao)(yao)(yao)物(wu)(wu)可适用(yong)优先审(shen)评(ping)审(shen)批程序,审(shen)评(ping)时限进一步缩短;三是(shi)上(shang)市(shi)申(shen)(shen)请阶段,药(yao)(yao)(yao)(yao)审(shen)中心会(hui)滚动接收其申(shen)(shen)报资料(liao),并优先安排核查、检验(yan)等,可大大缩减新药(yao)(yao)(yao)(yao)从研(yan)发到(dao)上(shang)市(shi)的(de)时间。2020年(nian)药(yao)(yao)(yao)(yao)审(shen)中心收到(dao)147件突破(po)(po)性(xing)(xing)治(zhi)(zhi)(zhi)(zhi)疗药(yao)(yao)(yao)(yao)物(wu)(wu)申(shen)(shen)请。经综合评(ping)估、公示,已将24件突破(po)(po)性(xing)(xing)治(zhi)(zhi)(zhi)(zhi)疗药(yao)(yao)(yao)(yao)物(wu)(wu)申(shen)(shen)请(21个品种)纳入(ru)突破(po)(po)性(xing)(xing)治(zhi)(zhi)(zhi)(zhi)疗药(yao)(yao)(yao)(yao)物(wu)(wu)程序,详(xiang)见附件5。

3.附条件批准(zhun)药(yao)物(wu)情况

附条件(jian)批(pi)准(zhun)上市(shi),目的在于(yu)缩短(duan)药(yao)物(wu)临(lin)床试(shi)验的研发时(shi)间,使其尽(jin)早(zao)(zao)应(ying)用(yong)于(yu)无法继续等待的危重疾病或公共卫生(sheng)方面急需的患者。药(yao)物(wu)有效(xiao)性评价的指标(biao)为临(lin)床终(zhong)点,符合附条件(jian)批(pi)准(zhun)上市(shi)情(qing)形的药(yao)物(wu),可使用(yong)替代终(zhong)点、中间临(lin)床终(zhong)点或早(zao)(zao)期(qi)临(lin)床试(shi)验数据来反映(ying)药(yao)物(wu)的有效(xiao)性,当这些数据能(neng)够(gou)提(ti)示药(yao)品的获益大于(yu)风(feng)险(xian)时(shi)候,即可申(shen)请附条件(jian)批(pi)准(zhun)上市(shi)。

对于若不尽早进行治疗则会(hui)在数(shu)月或者更(geng)短(duan)时间内导致(zhi)死亡的疾(ji)病患者来说,附条(tiao)件批准上(shang)市的药物(wu),使得这些无法继续等(deng)待的患者能(neng)够延续生命、提高(gao)生存质量(liang),消(xiao)除(chu)重大突(tu)发公(gong)共卫生事件对于人民生命安全的威胁。2020年药审(shen)中(zhong)心审(shen)评(ping)通过的新(xin)药上(shang)市申(shen)请(qing)中(zhong),共有(you)15件注(zhu)册申(shen)请(qing)经附条(tiao)件批准后上(shang)市,覆盖了新(xin)型冠状病毒感染引起的疾(ji)病、非小细胞肺癌(ai)、卵(luan)巢癌(ai)等(deng)适应(ying)症。

4.优(you)先审(shen)评药物情况

(1)优先审评品种(zhong)纳入情况

《药品注册管(guan)理办法》对优(you)(you)(you)先(xian)(xian)审评(ping)(ping)审批程(cheng)序的(de)(de)(de)(de)调整(zheng),是(shi)在多(duo)年实践经(jing)验基(ji)础(chu)上的(de)(de)(de)(de)优(you)(you)(you)化,一是(shi)适用范(fan)围更(geng)多(duo)地向具有(you)明(ming)显临床价值、临床急需(xu)和临床优(you)(you)(you)势的(de)(de)(de)(de)药物聚焦,致力(li)于将更(geng)多(duo)的(de)(de)(de)(de)临床价值显著、临床急需(xu)的(de)(de)(de)(de)短缺药品、防治(zhi)(zhi)重大传染(ran)病、罕(han)见(jian)病、儿童用药、纳(na)入突破性治(zhi)(zhi)疗(liao)程(cheng)序、符合附条件批准的(de)(de)(de)(de)药品等(deng)纳(na)入优(you)(you)(you)先(xian)(xian)审评(ping)(ping)程(cheng)序;二是(shi)审评(ping)(ping)时(shi)(shi)限的(de)(de)(de)(de)加速,药品上市许可申请(qing)的(de)(de)(de)(de)审评(ping)(ping)时(shi)(shi)限一般为200个工(gong)作(zuo)日(ri),与(yu)完(wan)整(zheng)的(de)(de)(de)(de)申报(bao)路径相比,优(you)(you)(you)先(xian)(xian)审评(ping)(ping)审批程(cheng)序的(de)(de)(de)(de)审评(ping)(ping)时(shi)(shi)限缩短至130个工(gong)作(zuo)日(ri),其中临床急需(xu)境外已(yi)上市罕(han)见(jian)病用药优(you)(you)(you)先(xian)(xian)审评(ping)(ping)审批程(cheng)序的(de)(de)(de)(de)审评(ping)(ping)时(shi)(shi)限为70个工(gong)作(zuo)日(ri)。药审中心通过优(you)(you)(you)化审评(ping)(ping)资源(yuan)配置率,在高标(biao)准完(wan)成(cheng)技术审评(ping)(ping)的(de)(de)(de)(de)前提下,力(li)争按时(shi)(shi)限完(wan)成(cheng)审评(ping)(ping),推(tui)动纳(na)入优(you)(you)(you)先(xian)(xian)审评(ping)(ping)审批程(cheng)序中的(de)(de)(de)(de)品种(zhong)尽快(kuai)获(huo)批上市。

根据(ju)《药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册管理办法(fa)》、46号公(gong)告(gao)、《国家食(shi)品(pin)(pin)(pin)药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)监督管理总局关于(yu)鼓励药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)创新实行优(you)(you)先(xian)审(shen)评(ping)审(shen)批(pi)的意(yi)见(jian)》(食(shi)药(yao)(yao)(yao)(yao)监药(yao)(yao)(yao)(yao)化管〔2017〕126号,以(yi)下简(jian)称(cheng)126号文(wen)件(jian)),2020年(nian)药(yao)(yao)(yao)(yao)审(shen)中(zhong)(zhong)心将219件(jian)(按(an)通用(yong)名计127个品(pin)(pin)(pin)种)注(zhu)册申请(qing)纳入(ru)优(you)(you)先(xian)审(shen)评(ping)审(shen)批(pi)程(cheng)序(xu)。其中(zhong)(zhong),144件(jian)注(zhu)册申请(qing)按(an)照126号文(wen)件(jian)规定(ding)的范围(wei)纳入(ru)优(you)(you)先(xian)审(shen)评(ping)审(shen)批(pi)程(cheng)序(xu),75件(jian)按(an)照《药(yao)(yao)(yao)(yao)品(pin)(pin)(pin)注(zhu)册管理办法(fa)》规定(ding)的范围(wei)纳入(ru)优(you)(you)先(xian)审(shen)评(ping)审(shen)批(pi)程(cheng)序(xu),包括42件(jian)儿童用(yong)药(yao)(yao)(yao)(yao)和(he)罕见(jian)病用(yong)药(yao)(yao)(yao)(yao)。2016-2020年(nian)纳入(ru)优(you)(you)先(xian)审(shen)评(ping)审(shen)批(pi)程(cheng)序(xu)的各类注(zhu)册申请(qing)情况(kuang)详见(jian)表6和(he)表7。

   

 

 

  按此前优先(xian)审评范围纳入的注册申(shen)(shen)请中(zhong),同步申(shen)(shen)报(bao)占(zhan)比多达44%(64/144),具有明(ming)显临床(chuang)价值的新药(yao)占(zhan)比为20%,按与原(yuan)研药(yao)质(zhi)量和疗效一致的标准完善后重新申(shen)(shen)报(bao)品种占(zhan)比则(ze)由(you)7.9%降至4.2%。

按照(zhao)《药(yao)品(pin)注册(ce)管(guan)理办法》优先(xian)(xian)审(shen)评范围纳入(ru)的(de)注册(ce)申请中(zhong),符合附条件批准的(de)药(yao)品(pin)占(zhan)比为36%(27/75),创新药(yao)和儿童用药(yao)占(zhan)比28%(21/75),优先(xian)(xian)审(shen)评资源(yuan)已向具有明显临床价值的(de)创新、急需药(yao)物倾斜。

(2)优先审评品种完成情况

2020年有217件注(zhu)册申请(按通用名计(ji)121个品(pin)种(zhong))通过(guo)优先审评(ping)程序建议批准上(shang)(shang)市(含(han)已(yi)上(shang)(shang)市药品(pin)新增适应症),审评(ping)通过(guo)件数较2019年增长(zhang)51.7%,例如(ru):我国自主研发的1类创新药甲磺酸(suan)阿(a)美(mei)替(ti)尼(ni)片、泽布替(ti)尼(ni)胶囊(nang)、奥(ao)布替(ti)尼(ni)片等,治疗罕见病法布雷病阿(a)加糖(tang)酶α注(zhu)射用浓溶液,用于配合饮食控制及运动治疗2型糖(tang)尿病的中药新药桑枝(zhi)总生物(wu)碱片、间(jian)变性淋巴瘤(liu)激酶抑(yi)制剂盐(yan)酸(suan)恩沙替(ti)尼(ni)胶囊(nang)、成人(ren)复(fu)发型多发性硬化治疗药物(wu)西尼(ni)莫(mo)德片等。2016-2020年优先审评(ping)通过(guo)的品(pin)种(zhong)情况(kuang)详见表8。

 

(八)药(yao)品注册(ce)现场核查(cha)相关情(qing)况

1.总体情况(kuang)

药(yao)审中心积极(ji)落(luo)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(he)查(cha)(cha)理念,将注(zhu)(zhu)(zhu)册(ce)现场核(he)查(cha)(cha)启动(dong)工(gong)作(zuo)模式由(you)基于审评需要调整为(wei)(wei)基于风险启动(dong),并联(lian)开展技术审评与注(zhu)(zhu)(zhu)册(ce)现场核(he)查(cha)(cha)工(gong)作(zuo);对(dui)于自2020年7月1日(ri)(ri)起(qi)受(shou)理的注(zhu)(zhu)(zhu)册(ce)申(shen)请,在受(shou)理后(hou)40个工(gong)作(zuo)日(ri)(ri)内决定是否(fou)启动(dong)相(xiang)应注(zhu)(zhu)(zhu)册(ce)现场核(he)查(cha)(cha)任务。为(wei)(wei)便(bian)于申(shen)请人及时获(huo)知(zhi)注(zhu)(zhu)(zhu)册(ce)现场核(he)查(cha)(cha)启动(dong)相(xiang)关(guan)信息(xi),完善药(yao)审中心网站申(shen)请人之(zhi)窗栏目,开通(tong)(tong)递(di)交注(zhu)(zhu)(zhu)册(ce)现场核(he)查(cha)(cha)用生产工(gong)艺(yi)与质(zhi)量标(biao)准通(tong)(tong)道和(he)查(cha)(cha)收注(zhu)(zhu)(zhu)册(ce)现场核(he)查(cha)(cha)电子通(tong)(tong)知(zhi)函的功能。

2.注(zhu)册现场核查(cha)具体(ti)情况

2020年,药(yao)(yao)审中(zhong)心(xin)基于(yu)品种因(yin)素和(he)研发生产主体合规因(yin)素风险启动注册现场核(he)查任(ren)务(wu)1235个(ge)(ge)。其中(zhong),药(yao)(yao)学现场核(he)查任(ren)务(wu)792个(ge)(ge),临床试验数据核(he)查任(ren)务(wu)439个(ge)(ge),药(yao)(yao)理毒(du)理研究核(he)查任(ren)务(wu)4个(ge)(ge)。

药(yao)审中(zhong)心接收(shou)核(he)查报告(gao)818份(fen)(fen)。其中(zhong),药(yao)学现场核(he)查报告(gao)449份(fen)(fen),临床试验(yan)核(he)查报告(gao)363份(fen)(fen),药(yao)理(li)(li)毒(du)理(li)(li)研(yan)究核(he)查报告(gao)6份(fen)(fen)。

(九)沟通(tong)交流(liu)情(qing)况

1.总体情(qing)况

2020年,药(yao)(yao)审中(zhong)心在(zai)落实疫(yi)情(qing)防(fang)控要求的(de)同时,尽量满(man)足申(shen)(shen)请(qing)人(ren)的(de)需要,全力(li)保障各类(lei)沟(gou)(gou)(gou)(gou)通(tong)交流畅通(tong)。在(zai)推动新(xin)冠(guan)(guan)病毒(du)疫(yi)苗(miao)和新(xin)冠(guan)(guan)肺炎治(zhi)疗药(yao)(yao)物(wu)的(de)研发(fa)方(fang)(fang)面,为79个(ge)(ge)新(xin)冠(guan)(guan)病毒(du)疫(yi)苗(miao),中(zhong)医药(yao)(yao)、中(zhong)和抗(kang)体(ti)(27个(ge)(ge))等(deng)新(xin)冠(guan)(guan)肺炎治(zhi)疗药(yao)(yao)物(wu),组织申(shen)(shen)请(qing)人(ren)与药(yao)(yao)审中(zhong)心审评团(tuan)队之间的(de)沟(gou)(gou)(gou)(gou)通(tong)交流5600余次,并针对新(xin)冠(guan)(guan)病毒(du)疫(yi)苗(miao)、中(zhong)和抗(kang)体(ti)等(deng)重点(dian)品种,单独设立(li)(li)了台账(zhang),动态跟进;在(zai)维护(hu)与申(shen)(shen)请(qing)人(ren)沟(gou)(gou)(gou)(gou)通(tong)桥(qiao)梁方(fang)(fang)面,药(yao)(yao)审中(zhong)心发(fa)布(bu)了《药(yao)(yao)物(wu)研发(fa)与技(ji)术审评沟(gou)(gou)(gou)(gou)通(tong)交流管理(li)办法》《药(yao)(yao)审中(zhong)心关(guan)于业(ye)务(wu)咨询(xun)(xun)服(fu)务(wu)联(lian)络方(fang)(fang)式的(de)通(tong)知》,优化(hua)了电(dian)话(hua)咨询(xun)(xun)服(fu)务(wu),每天有(you)专人(ren)接听解(jie)答申(shen)(shen)请(qing)人(ren)咨询(xun)(xun)电(dian)话(hua),根据咨询(xun)(xun)问题类(lei)型的(de)不(bu)同设立(li)(li)了8个(ge)(ge)联(lian)系(xi)邮箱,及时解(jie)答处理(li)申(shen)(shen)请(qing)人(ren)问题,不(bu)断提高沟(gou)(gou)(gou)(gou)通(tong)交流的(de)质量和效率。

药审中心接(jie)(jie)(jie)收沟(gou)(gou)通交(jiao)流会(hui)(hui)议(yi)申请3229件(jian)(jian),较2019年(nian)增(zeng)长22.64%,办理沟(gou)(gou)通交(jiao)流会(hui)(hui)议(yi)申请2451件(jian)(jian),较2019年(nian)增(zeng)长31.00%。在网络平(ping)台(tai)接(jie)(jie)(jie)收一(yi)般性技(ji)(ji)术(shu)问题(ti)咨(zi)询(xun)20285个,较2019年(nian)增(zeng)长22.41%;接(jie)(jie)(jie)收电(dian)话咨(zi)询(xun)超过上万(wan)次,邮件(jian)(jian)咨(zi)询(xun)数千件(jian)(jian),同时也面向社会(hui)(hui)提供(gong)现场咨(zi)询(xun)服(fu)务。2016-2020年(nian)接(jie)(jie)(jie)收沟(gou)(gou)通交(jiao)流申请和一(yi)般性技(ji)(ji)术(shu)问题(ti)咨(zi)询(xun)具体情(qing)况详见图16。

 

2.沟通交(jiao)流会议申请的(de)完成情况

药(yao)审(shen)中(zhong)心所接收的(de)3229件沟(gou)通(tong)(tong)交流会(hui)议(yi)申(shen)(shen)请中(zhong),符合会(hui)议(yi)召(zhao)开(kai)(kai)(kai)条(tiao)件的(de),及时与(yu)申(shen)(shen)请人取得(de)了联系,商议(yi)会(hui)议(yi)细节;无需(xu)召(zhao)开(kai)(kai)(kai)会(hui)议(yi)的(de),以书面形式尽快回复了申(shen)(shen)请人。2020年共办(ban)理了2451件沟(gou)通(tong)(tong)交流会(hui)议(yi)申(shen)(shen)请。在药(yao)物研发关键阶段召(zhao)开(kai)(kai)(kai)的(de)Ⅱ类会(hui)议(yi)占比76.42%,其中(zhong)临(lin)床前(Pre-IND)申(shen)(shen)请占比37.49%。2020年各类沟(gou)通(tong)(tong)交流会(hui)议(yi)申(shen)(shen)请及办(ban)理情况详见表9。

 

  沟(gou)(gou)通(tong)交(jiao)(jiao)流(liu)会(hui)议(yi)(yi)的(de)形式(shi)为电话(hua)会(hui)议(yi)(yi)、视频会(hui)议(yi)(yi)、面(mian)对(dui)面(mian)会(hui)议(yi)(yi),共召开沟(gou)(gou)通(tong)交(jiao)(jiao)流(liu)会(hui)议(yi)(yi)268次,以书面(mian)形式(shi)回复两千余件(jian)。2018-2020年各类沟(gou)(gou)通(tong)交(jiao)(jiao)流(liu)会(hui)议(yi)(yi)的(de)召开情况详见表10。

 

3.一(yi)般性技术问题答复情况

药(yao)(yao)审中(zhong)心通过网上(shang)咨询平台共接收了20285个(ge)(ge)一般性技术(shu)问(wen)题的咨询。按照内(nei)容(rong)分类(lei),问(wen)题主(zhu)要(yao)集中(zhong)于(yu)受理(4038个(ge)(ge))、原(yuan)辅包(3952个(ge)(ge))等方(fang)面;按照药(yao)(yao)品(pin)分类(lei),问(wen)题主(zhu)要(yao)集中(zhong)于(yu)化(hua)(hua)学药(yao)(yao)(11338个(ge)(ge))方(fang)面,其中(zhong)化(hua)(hua)学药(yao)(yao)受理(2396个(ge)(ge))、化(hua)(hua)学药(yao)(yao)一致(zhi)性评价(1258个(ge)(ge))。一般性技术(shu)问(wen)题答复具体情(qing)况详(xiang)见表11。

 

二、药品(pin)注册申请受理情况(kuang)

(一)总体情(qing)况

2020年(nian),根据46号公告(gao)、《国(guo)(guo)家药(yao)监局关(guan)(guan)于发布(bu)(bu)生(sheng)物(wu)制品注(zhu)(zhu)册分类(lei)及申(shen)(shen)报(bao)资料(liao)要(yao)求(qiu)的(de)(de)(de)(de)通告(gao)》(2020年(nian)第(di)43号)、《国(guo)(guo)家药(yao)监局关(guan)(guan)于发布(bu)(bu)化(hua)学药(yao)品注(zhu)(zhu)册分类(lei)及申(shen)(shen)报(bao)资料(liao)要(yao)求(qiu)的(de)(de)(de)(de)通告(gao)》(2020年(nian)第(di)44号)、《国(guo)(guo)家药(yao)监局关(guan)(guan)于发布(bu)(bu)<中(zhong)药(yao)注(zhu)(zhu)册分类(lei)及申(shen)(shen)报(bao)资料(liao)要(yao)求(qiu)>的(de)(de)(de)(de)通告(gao)》(2020年(nian)第(di)68号)等,药(yao)审(shen)(shen)(shen)中(zhong)心(xin)受理中(zhong)药(yao)、化(hua)学药(yao)、生(sheng)物(wu)制品各(ge)类(lei)注(zhu)(zhu)册申(shen)(shen)请(qing)共10245件(jian)(含药(yao)械组合产(chan)品6件(jian)),较2019年(nian)增长26.76%。其(qi)中(zhong),需(xu)技术审(shen)(shen)(shen)评的(de)(de)(de)(de)注(zhu)(zhu)册申(shen)(shen)请(qing)7147件(jian)(含5695件(jian)需(xu)药(yao)审(shen)(shen)(shen)中(zhong)心(xin)技术审(shen)(shen)(shen)评和行政(zheng)(zheng)审(shen)(shen)(shen)批的(de)(de)(de)(de)注(zhu)(zhu)册申(shen)(shen)请(qing)),较2019年(nian)增长15.29%;直接行政(zheng)(zheng)审(shen)(shen)(shen)批的(de)(de)(de)(de)注(zhu)(zhu)册申(shen)(shen)请(qing)3092件(jian),较2019年(nian)增长64.64%。

受(shou)(shou)理的10239件药(yao)品注(zhu)(zhu)册(ce)申(shen)(shen)请中,化学药(yao)注(zhu)(zhu)册(ce)申(shen)(shen)请受(shou)(shou)理量为7901件,较2019年(nian)(nian)增长(zhang)22.02%,占2020年(nian)(nian)全(quan)部注(zhu)(zhu)册(ce)申(shen)(shen)请受(shou)(shou)理量的77.17%,2016-2020年(nian)(nian)各(ge)类(lei)药(yao)品注(zhu)(zhu)册(ce)申(shen)(shen)请受(shou)(shou)理情况(kuang)详见图(tu)17。

 

2.药审中(zhong)心的直接行(xing)政审批(pi)工作自2017年(nian)开始,故2016年(nian)无直接行(xing)政审批(pi)注册(ce)(ce)申请,所有受(shou)理注册(ce)(ce)申请均需技(ji)术审评。

2020年受理的需技术(shu)(shu)审评的注册(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)7147件中,化学药(yao)(yao)注册(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)为5402件,较(jiao)2019年增长(zhang)9.42%,占(zhan)全部(bu)需技术(shu)(shu)审评的注册(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)受理量的75.58%;中药(yao)(yao)注册(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)315件,较(jiao)2019年增长(zhang)22.57%;生物(wu)制(zhi)品(pin)注册(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)1430件,较(jiao)2019年增长(zhang)42.29%。2016-2020年需技术(shu)(shu)审评的中药(yao)(yao)、化学药(yao)(yao)、生物(wu)制(zhi)品(pin)各类注册(ce)(ce)申(shen)(shen)(shen)请(qing)(qing)受理情况详见图(tu)18。

 

(二(er))1类创新药(yao)受理情况

2020年(nian)(nian),药(yao)(yao)(yao)(yao)审(shen)中(zhong)心(xin)受(shou)(shou)理1类创(chuang)新药(yao)(yao)(yao)(yao)注册申请共1062件(597个品种),较(jiao)2019年(nian)(nian)增长(zhang)51.71%。其中(zhong),受(shou)(shou)理IND申请1008件(559个品种),较(jiao)2019年(nian)(nian)增长(zhang)49.78%;受(shou)(shou)理NDA 54件(38个品种),较(jiao)2019年(nian)(nian)增长(zhang)100.00%。以药(yao)(yao)(yao)(yao)品类别统计,中(zhong)药(yao)(yao)(yao)(yao)、化学(xue)药(yao)(yao)(yao)(yao)、生(sheng)物制品1类创(chuang)新药(yao)(yao)(yao)(yao)受(shou)(shou)理量(liang)分别为14、752、296件。以生(sheng)产场地统计,境(jing)内生(sheng)产药(yao)(yao)(yao)(yao)品843件,境(jing)外(wai)生(sheng)产药(yao)(yao)(yao)(yao)品219件。详见表12和13。

 

(三)各(ge)类注册申请受(shou)理情况

1.中药注册申请受理情况

2020年(nian),药(yao)(yao)审中(zhong)(zhong)(zhong)心受理(li)中(zhong)(zhong)(zhong)药(yao)(yao)注册申(shen)请(qing)471件。其中(zhong)(zhong)(zhong),受理(li)中(zhong)(zhong)(zhong)药(yao)(yao)IND申(shen)请(qing)22件,受理(li)中(zhong)(zhong)(zhong)药(yao)(yao)NDA 6件,受理(li)中(zhong)(zhong)(zhong)药(yao)(yao)ANDA 1件。2020年(nian)中(zhong)(zhong)(zhong)药(yao)(yao)各类(lei)注册申(shen)请(qing)受理(li)情况详见图19。

 

  受(shou)(shou)(shou)理(li)1类中药创新药注册申请14件。其中,受(shou)(shou)(shou)理(li)IND 申请9件(9个品种),受(shou)(shou)(shou)理(li)NDA 5件(5个品种)。

2.化学药注册(ce)申请受理情(qing)况

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

 

 

药审中心受理(li)(li)1类创新化学药注(zhu)册申请752件(jian)(360个品种),较(jiao)(jiao)2019年增长(zhang)(zhang)31.24%。其中,受理(li)(li)IND申请721件(jian)(339个品种),较(jiao)(jiao)2019年增长(zhang)(zhang)30.62%;受理(li)(li)NDA 31件(jian)(21个品种),较(jiao)(jiao)2019年增长(zhang)(zhang)47.62%。

药审中心(xin)受理化学药5.1类注(zhu)册申请160件,较2019年(nian)增(zeng)长(zhang)1.91%。其中受理临床试验(yan)申请(验(yan)证性(xing)临床)53件,受理NDA 107件。

360个(ge)品种的1类(lei)创新化学(xue)药注(zhu)册申(shen)请(qing)(qing)中,境内生产化学(xue)药注(zhu)册申(shen)请(qing)(qing)为(wei)258个(ge)品种,境外生产化学(xue)药注(zhu)册申(shen)请(qing)(qing)为(wei)102个(ge)品种。2016-2020年1类(lei)创新化学(xue)药注(zhu)册申(shen)请(qing)(qing)受理情况详(xiang)见图(tu)22。

 

3.生物制(zhi)品(pin)注册申请受理情况

2020年,药审中心受(shou)(shou)理(li)生(sheng)物(wu)(wu)制品(pin)注册申(shen)请(qing)1867件(jian)(jian)。其中,受(shou)(shou)理(li)生(sheng)物(wu)(wu)制品(pin)IND申(shen)请(qing)580件(jian)(jian)(预(yu)防(fang)用(yong)(yong)IND申(shen)请(qing)25件(jian)(jian),治(zhi)(zhi)疗用(yong)(yong)IND申(shen)请(qing)555件(jian)(jian)),较(jiao)2019年增长(zhang)87.10%;受(shou)(shou)理(li)生(sheng)物(wu)(wu)制品(pin)NDA 126件(jian)(jian)(预(yu)防(fang)用(yong)(yong)NDA 7件(jian)(jian),治(zhi)(zhi)疗用(yong)(yong)NDA 117件(jian)(jian),体外诊断试剂2件(jian)(jian)),较(jiao)2019年增长(zhang)1.62%。2020年生(sheng)物(wu)(wu)制品(pin)各类注册申(shen)请(qing)受(shou)(shou)理(li)情况详(xiang)见图23。2016-2020年生(sheng)物(wu)(wu)制品(pin)IND申(shen)请(qing)和(he)NDA受(shou)(shou)理(li)情况详(xiang)见图24。

 

 

 

药审中(zhong)心受(shou)理(li)(li)1类(lei)创新生(sheng)(sheng)(sheng)(sheng)物(wu)制品(pin)注(zhu)册申请296件(jian)(jian)(223个(ge)品(pin)种),较(jiao)2019年增长(zhang)133.07%。其中(zhong),受(shou)理(li)(li)预防用生(sheng)(sheng)(sheng)(sheng)物(wu)制品(pin)5件(jian)(jian),受(shou)理(li)(li)治疗(liao)用生(sheng)(sheng)(sheng)(sheng)物(wu)制品(pin)291件(jian)(jian);受(shou)理(li)(li)生(sheng)(sheng)(sheng)(sheng)物(wu)制品(pin)IND申请278件(jian)(jian)(211个(ge)品(pin)种),较(jiao)2019年增长(zhang)129.75%;受(shou)理(li)(li)生(sheng)(sheng)(sheng)(sheng)物(wu)制品(pin)NDA 18件(jian)(jian)(12个(ge)品(pin)种),较(jiao)2019年增长(zhang)200.00%,具体情(qing)况详见表14。

 

4.行政(zheng)审批注册申请受(shou)理情况

(1)总体情况

2020年(nian)(nian)(nian),药审(shen)(shen)(shen)中心受(shou)理(li)需中心行(xing)政审(shen)(shen)(shen)批的(de)中药、化学药、生物制品(pin)各类(lei)注册(ce)(ce)申请(qing)(qing)(qing)8787件,较(jiao)2019年(nian)(nian)(nian)增长29.51%。其中,受(shou)理(li)需审(shen)(shen)(shen)评审(shen)(shen)(shen)批的(de)注册(ce)(ce)申请(qing)(qing)(qing)(临床试验申请(qing)(qing)(qing)、一致性评价申请(qing)(qing)(qing)、补充申请(qing)(qing)(qing)、境外生产药品(pin)再注册(ce)(ce)及复审(shen)(shen)(shen))5695件,较(jiao)2019年(nian)(nian)(nian)增长16.06%;受(shou)理(li)直接(jie)行(xing)政审(shen)(shen)(shen)批的(de)注册(ce)(ce)申请(qing)(qing)(qing)(无需技术审(shen)(shen)(shen)评的(de)补充申请(qing)(qing)(qing)、临时进口申请(qing)(qing)(qing))3092件,较(jiao)2019年(nian)(nian)(nian)增长64.64%。2020年(nian)(nian)(nian)行(xing)政审(shen)(shen)(shen)批注册(ce)(ce)申请(qing)(qing)(qing)受(shou)理(li)的(de)具体(ti)情(qing)况(kuang)详见表15。2016-2020年(nian)(nian)(nian)行(xing)政审(shen)(shen)(shen)批注册(ce)(ce)申请(qing)(qing)(qing)受(shou)理(li)情(qing)况(kuang)详见图25。

 

(2)需审(shen)评审(shen)批的注册申请(qing)受理情(qing)况

药审(shen)中(zhong)心(xin)受理(li)5695件(jian)需审(shen)评审(shen)批(pi)的注册申请(qing)(qing)中(zhong),临床试验(yan)申请(qing)(qing)1618件(jian)(含验(yan)证性(xing)临床)、一(yi)致性(xing)评价申请(qing)(qing)914件(jian)、补充申请(qing)(qing)2827件(jian)、境(jing)外生产药品再(zai)注册328件(jian)、复审(shen)8件(jian)。

(3)直(zhi)接行(xing)政审批的注册申请受(shou)理情况

药(yao)(yao)审(shen)(shen)中心受(shou)理3092件直接行(xing)政(zheng)审(shen)(shen)批(pi)的注册申(shen)请中,按申(shen)请类型划(hua)分(fen)(fen),补充申(shen)请2644件、临时(shi)进口申(shen)请448件。按药(yao)(yao)品(pin)类型划(hua)分(fen)(fen),中药(yao)(yao)156件、化学药(yao)(yao)2499件、生物制(zhi)品(pin)437件。

 三、重点(dian)治疗领域(yu)品种

新(xin)冠(guan)病毒疫(yi)苗和(he)新(xin)冠(guan)肺炎治(zhi)疗药物:

1.新(xin)型冠状病毒灭(mie)活疫(yi)苗(Vero细胞),为(wei)国内首个附条件批(pi)准的(de)新(xin)冠病毒疫(yi)苗,也(ye)是全球首个新(xin)冠病毒灭(mie)活疫(yi)苗。适(shi)用于18岁及以上人群预防由新(xin)型冠状病毒(SARS-CoV-2)感染引起的(de)疾病。

2.“三药(yao)”品种,为《新(xin)型(xing)(xing)冠(guan)状(zhuang)(zhuang)病(bing)毒肺(fei)炎诊疗方(fang)案(试行)》推荐药(yao)物,即连花(hua)清瘟颗(ke)(ke)粒(li)/胶(jiao)囊、金花(hua)清感颗(ke)(ke)粒(li)和血(xue)必净注射(she)液(ye)。连花(hua)清瘟颗(ke)(ke)粒(li)/胶(jiao)囊和金花(hua)清感颗(ke)(ke)粒(li)新(xin)增适应症(zheng)(zheng)用于(yu)在新(xin)型(xing)(xing)冠(guan)状(zhuang)(zhuang)病(bing)毒肺(fei)炎的(de)常规治疗中的(de)轻型(xing)(xing)、普通(tong)型(xing)(xing)引起(qi)的(de)发(fa)热、咳嗽、乏力(li),血(xue)必净注射(she)液(ye)新(xin)增适应症(zheng)(zheng)用于(yu)新(xin)型(xing)(xing)冠(guan)状(zhuang)(zhuang)病(bing)毒肺(fei)炎重型(xing)(xing)、危重型(xing)(xing)的(de)全身炎症(zheng)(zheng)反应综合征或(huo)/和多脏器功能衰竭,其获批上市充分发(fa)挥了中医药(yao)在疫情防(fang)控中的(de)作用。

3.注射用(yong)西维来司他(ta)钠,为中性(xing)粒细(xi)胞弹性(xing)蛋白酶选择(ze)性(xing)抑制剂(ji),适用(yong)于改(gai)善伴有全身性(xing)炎症反应综合征的急性(xing)肺损伤(shang)/急性(xing)呼吸(xi)窘迫综合征(ALI/ARDS),是全球(qiu)唯一(yi)用(yong)于ALI/ARDS的药物,其(qi)获批(pi)上(shang)市填补了我(wo)国(guo)ALI/ARDS药物治疗领(ling)域的空白,为我(wo)国(guo)呼吸(xi)系统危(wei)重症患者(zhe)提供用(yong)药选择(ze)。

抗肿瘤药物:

4.甲磺酸阿美(mei)替(ti)尼片,为我(wo)国(guo)首个具有自(zi)主知识产权的(de)第(di)三代靶向表皮生长因子受体(EGFR)小(xiao)分(fen)子酪氨酸激酶抑制(zhi)剂(TKI)创新药(yao)物(wu),适用于治疗(liao)(liao)(liao)既往经(jing)EGFR-TKI治疗(liao)(liao)(liao)时或(huo)治疗(liao)(liao)(liao)后出现疾(ji)病进展(zhan),并且(qie)经(jing)检(jian)测确认(ren)存(cun)在EGFR T790M突(tu)变阳(yang)性(xing)的(de)局部(bu)晚期或(huo)转移性(xing)非小(xiao)细胞肺癌(ai)。本(ben)品疗(liao)(liao)(liao)效(xiao)突(tu)出,脑转移病灶控制(zhi)良好,其获批上市将显著改善该(gai)疾(ji)病治疗(liao)(liao)(liao)药(yao)物(wu)的(de)可(ke)及性(xing)。

5.索(suo)凡(fan)替尼胶囊,为多靶(ba)点、抗(kang)血管生(sheng)成口服小分(fen)子酪氨酸激酶抑制剂(ji),是(shi)国内(nei)首(shou)个用于治疗无法手术切(qie)除的(de)局(ju)部晚(wan)期或转移性(xing)、进展(zhan)期非(fei)功能性(xing)、分(fen)化良好(hao)(G1、G2)的(de)非(fei)胰(yi)腺来源的(de)神经内(nei)分(fen)泌瘤的(de)创新药物。本品疗效(xiao)突出(chu),显著降(jiang)低了此类患者的(de)疾病(bing)进展(zhan)和死亡风险,其获批上市填补(bu)了该疾病(bing)治疗领域的(de)空(kong)白。

6.注射(she)用维布妥昔单抗(kang),为全球(qiu)首个CD30靶点抗(kang)体偶(ou)联药物(wu)(ADC),也是国内首个用于恶(e)性淋巴瘤(liu)患者(zhe)的ADC药物(wu),适用于治(zhi)(zhi)疗(liao)复(fu)发或难治(zhi)(zhi)性的系统(tong)性间变性大细(xi)胞淋巴瘤(liu)和经典型霍奇金淋巴瘤(liu),本品(pin)获批上市(shi)为改善我国此(ci)类患者(zhe)的长期生存提(ti)供了有效的治(zhi)(zhi)疗(liao)手段(duan)。

7.注射用贝林妥欧(ou)单抗,为全球首(shou)个双特异性(xing)抗体(ti)(CD3和CD19靶点)药物,也(ye)是(shi)我国(guo)首(shou)个用于(yu)肿瘤适应症的(de)双特异性(xing)抗体(ti)药物,适用于(yu)治疗(liao)成人复发(fa)或(huo)难治性(xing)前体(ti)B细(xi)胞急性(xing)淋(lin)(lin)巴细(xi)胞白(bai)血病(bing)。对于(yu)化(hua)疗(liao)失败的(de)复发(fa)或(huo)难治性(xing)急性(xing)淋(lin)(lin)巴细(xi)胞白(bai)血病(bing)患者,与标准化(hua)疗(liao)相比,本品(pin)可显著延长患者生存期,其获批上市(shi)为我国(guo)此(ci)类(lei)患者提供了更好的(de)治疗(liao)手段。

8.甲磺(huang)酸(suan)仑伐(fa)替尼胶囊,为(wei)多靶点、口服酪氨(an)酸(suan)激(ji)酶抑(yi)制剂,是国内首个用(yong)于(yu)治(zhi)(zhi)疗进展性、局(ju)部(bu)晚期或转移性放射(she)性碘难治(zhi)(zhi)性分化型(xing)甲状腺癌的(de)小分子药物(wu)。本品疗效突出(chu),其获(huo)批上市(shi)为(wei)我国此类患(huan)者提(ti)供了(le)有效的(de)治(zhi)(zhi)疗方案,填补了(le)该治(zhi)(zhi)疗领域(yu)的(de)空白。

抗感染药(yao)物:

9.盐酸(suan)可洛(luo)派韦胶囊,为非(fei)结构蛋白5A(NS5A)抑制剂(ji),是我国具有自主知识产权的(de)广谱、直(zhi)接抗丙(bing)肝(gan)(gan)病(bing)毒(du)创新药物,适(shi)用(yong)于(yu)与索磷布韦联用(yong)治(zhi)疗初(chu)治(zhi)或(huo)干扰素(su)经治(zhi)的(de)基因1、2、3、6型成人慢性丙(bing)型肝(gan)(gan)炎(yan)病(bing)毒(du)感(gan)染(ran),可合并(bing)或(huo)不合并(bing)代(dai)偿性肝(gan)(gan)硬化,本品(pin)获批上市为我国慢性丙(bing)肝(gan)(gan)患者(zhe)提供了一种新的(de)治(zhi)疗选择。

10.恩曲他(ta)滨替诺福韦(wei)片(pian),增(zeng)加适应症用(yong)于(yu)降低(di)成人(ren)和(he)青少年(体重至少在35 kg以上)通过(guo)高(gao)风险(xian)性行为(wei)获得HIV-1的风险(xian),是国(guo)内首个用(yong)于(yu)暴(bao)露前(qian)预防HIV的药物。HIV感(gan)染(ran)是重大公共卫生问题,本品(pin)获批(pi)上市对于(yu)控制HIV传播具有重大意义。

循环系(xi)统(tong)药物(wu):

11.拉那(nei)利尤(you)单抗(kang)(kang)注射液,为(wei)全人源(yuan)化单克隆抗(kang)(kang)体(IgG1/K-轻链),是我(wo)国首个用(yong)于12岁及(ji)以上(shang)患(huan)者预防(fang)遗(yi)传性血管性水肿(HAE)发(fa)作(zuo)的药(yao)物(wu)。HAE疾病反复发(fa)作(zuo),近半数患(huan)者可出现上(shang)呼吸道黏膜水肿引发(fa)窒息而危及(ji)生命,本品(pin)获批上(shang)市为(wei)我(wo)国HAE患(huan)者预防(fang)发(fa)作(zuo)提供了安(an)全有效的治疗手(shou)段。

12.氯苯唑酸(suan)软(ruan)胶囊,为转甲状腺素蛋白(TTR)稳定剂,适(shi)用于治(zhi)疗转甲状腺素蛋白淀粉样变(bian)性心(xin)肌(ji)病(bing)(bing)(bing),以减少心(xin)血(xue)(xue)管死亡及心(xin)血(xue)(xue)管相关住院。该疾病(bing)(bing)(bing)是一种致命性疾病(bing)(bing)(bing),属(shu)罕见病(bing)(bing)(bing),本品为我国(guo)首个(ge)针对该病(bing)(bing)(bing)病(bing)(bing)(bing)因治(zhi)疗的药物,其获批(pi)上市为我国(guo)此类患者提供了新的治(zhi)疗手(shou)段(duan)。

呼吸系(xi)统药(yao)物:

13.苯环喹(kui)溴铵鼻(bi)喷雾剂(ji),为胆碱(jian)能受体拮抗剂(ji),为我国首个具有自主知识(shi)产权(quan)用于变应性鼻(bi)炎的鼻(bi)用抗胆碱(jian)创新(xin)药物,适用于改善(shan)变应性鼻(bi)炎引起的流(liu)涕、鼻(bi)塞、鼻(bi)痒和(he)喷嚏症状,本品其获批上市可为我国此类(lei)患者(zhe)提供新(xin)的治疗(liao)选择。

14.乙磺酸尼(ni)达尼(ni)布软(ruan)胶(jiao)囊,为(wei)小分子(zi)酪氨酸激酶抑(yi)制剂,具有抗(kang)纤(xian)维化(hua)作用(yong),增加适应症用(yong)于治(zhi)疗系统性(xing)(xing)(xing)硬化(hua)病(bing)相关间(jian)质性(xing)(xing)(xing)肺(fei)疾(ji)病(bing)(SSc-ILD)和具有进行性(xing)(xing)(xing)表(biao)型的慢性(xing)(xing)(xing)纤(xian)维化(hua)性(xing)(xing)(xing)间(jian)质性(xing)(xing)(xing)肺(fei)疾(ji)病(bing)(PF-ILD)。目(mu)前可用(yong)于SSc-ILD和PF-ILD的有效治(zhi)疗方式有限,临(lin)床(chuang)用(yong)药需求迫(po)切,本品获批(pi)新增适应症可以填(tian)补该治(zhi)疗领域空(kong)白(bai),为(wei)我国此类(lei)患者提供药物(wu)选择。

神(shen)经系统药物(wu):

15.氘丁苯那嗪片,为(wei)囊泡单胺转运蛋白(bai)2(VMAT2)抑制剂(ji),是我国首个用于治疗与罕见病(bing)亨廷顿病(bing)有关(guan)的舞(wu)蹈(dao)病(bing)、迟发(fa)性运动障碍的药物,属临床急需境外新(xin)药名单品(pin)种,本品(pin)获(huo)批上市满足了我国此类患者迫切的临床需求(qiu)。

16.氯苯唑(zuo)酸葡胺软胶囊(nang),为(wei)转甲(jia)状(zhuang)(zhuang)腺素蛋白(TTR)稳定剂,是我国首(shou)个用(yong)于治(zhi)疗成(cheng)人转甲(jia)状(zhuang)(zhuang)腺素蛋白淀粉样变(bian)性多发(fa)性神经病(bing)I期症状(zhuang)(zhuang)患(huan)者、延缓周围(wei)神经功能损害的药物,属临床(chuang)急需(xu)境外新药名单品种,其获(huo)批(pi)上市(shi)改变(bian)了(le)该病(bing)无药可治(zhi)的局面。

镇痛(tong)药及麻醉科药物:

17.环(huan)泊酚(fen)(fen)注射(she)(she)液,为(wei)GABAA受(shou)体(ti)激动剂,是用(yong)于(yu)消化(hua)道内镜检查(cha)中镇(zhen)静的(de)创新药(yao)物(wu)。本品(pin)与临床常用(yong)麻醉镇(zhen)静药(yao)物(wu)丙泊酚(fen)(fen)具(ju)有相似的(de)药(yao)理机(ji)制(zhi),但具(ju)有起效(xiao)快(kuai),注射(she)(she)痛少,呼吸抑制(zhi)轻(qing),恢复(fu)速度(du)快(kuai)等优势特征,其获批上市(shi)可(ke)为(wei)我国消化(hua)内镜检查(cha)操作用(yong)药(yao)提供(gong)新的(de)选择。

皮肤五官药物:

18.塞奈(nai)吉(ji)明滴眼液,为(wei)国内首个用于治疗(liao)神(shen)经营养性角膜炎(NK)的(de)(de)重(zhong)(zhong)组人(ren)神(shen)经生长(zhang)因(yin)子(zi)(rhNGF)药物,属临床急需(xu)境外新(xin)药名单品种。NK为(wei)罕(han)见的(de)(de)退行性角膜疾病,可(ke)致盲,中(zhong)重(zhong)(zhong)度(du)NK手术治疗(liao)为(wei)侵入性操(cao)作,费用高且不能永久治愈(yu),本品获批(pi)上市为(wei)我国此类患(huan)者提供了有效的(de)(de)治疗(liao)药物,预计(ji)将(jiang)成为(wei)中(zhong)重(zhong)(zhong)度(du)NK患(huan)者的(de)(de)首选治疗(liao)。

19.度普(pu)利(li)尤单(dan)抗(kang)注(zhu)射液,为(wei)重(zhong)组人免(mian)疫球(qiu)蛋白-G4单(dan)克(ke)隆抗(kang)体(ti),适用(yong)于治疗(liao)外用(yong)处方(fang)药控制不佳或不建(jian)议使用(yong)外用(yong)处方(fang)药的成人中重(zhong)度特应(ying)性皮炎,属临床(chuang)急(ji)需境(jing)外新药名单(dan)品种。与现(xian)有治疗(liao)方(fang)式相(xiang)比,本品有明显临床(chuang)优势,其获批(pi)上市为(wei)此类(lei)难治性严重(zhong)疾病患者提(ti)供了治疗(liao)选(xuan)择(ze)。

消化系统药物:

20.注射用(yong)(yong)维得利珠单(dan)抗(kang),为作用(yong)(yong)于(yu)人淋巴细胞整合素α4β7的(de)(de)(de)人源(yuan)化单(dan)克(ke)隆抗(kang)体,适用(yong)(yong)于(yu)治(zhi)(zhi)疗(liao)对(dui)传统治(zhi)(zhi)疗(liao)或(huo)肿瘤坏死因子α(TNF-α)抑制剂应(ying)答不充(chong)分、失应(ying)答或(huo)不耐受的(de)(de)(de)中度(du)至(zhi)重(zhong)度(du)活动性溃疡性结肠炎、克(ke)罗恩病(bing),属临(lin)床急需境外(wai)新药名(ming)单(dan)品种。此类疾病(bing)存在(zai)迫切的(de)(de)(de)临(lin)床治(zhi)(zhi)疗(liao)需求(qiu),特别(bie)是对(dui)于(yu)TNF-α拮抗(kang)剂治(zhi)(zhi)疗(liao)失败的(de)(de)(de)患者,本品获批上市可为临(lin)床提(ti)供新的(de)(de)(de)治(zhi)(zhi)疗(liao)选择(ze)。

外科药物(wu):

21.注射用丹(dan)曲林钠,适用于预防及(ji)治(zhi)疗恶性高热(MH),是目(mu)前唯一短时间内给药(yao)可(ke)改变该疾病转归(gui)的药(yao)物。MH临床(chuang)结局(ju)危重,死亡率高,其(qi)获批上市可(ke)改变目(mu)前国内MH无安全有效治(zhi)疗手段(duan)的现状,满足迫切临床(chuang)需(xu)求。

22.他(ta)克莫司颗粒,适用(yong)于预防儿童肝脏(zang)(zang)或(huo)(huo)肾脏(zang)(zang)移植(zhi)术后的移植(zhi)物(wu)(wu)排斥反(fan)应(ying),治疗儿童肝脏(zang)(zang)或(huo)(huo)肾脏(zang)(zang)移植(zhi)术后应(ying)用(yong)其他(ta)免疫抑制药物(wu)(wu)无法控制的移植(zhi)物(wu)(wu)排斥反(fan)应(ying),属儿童用(yong)药,本品获批上市可极大解决(jue)我国儿科肝肾移植(zhi)患者未满足的临(lin)床需求。

罕见(jian)病(bing)药(yao)物:

23.注射用拉(la)罗尼(ni)酶(mei)浓溶液,为国内首个(ge)用于罕见病黏(nian)多糖(tang)贮积(ji)症(zheng)I型(MPS I,α-L-艾杜糖(tang)苷酶(mei)缺乏症(zheng))的酶(mei)替代(dai)治疗药物,属(shu)临床急(ji)需境外新药名单品种。黏(nian)多糖(tang)贮积(ji)症(zheng)I型是一种严重(zhong)危(wei)及生(sheng)命且国内尚无有效治疗手(shou)段(duan)的遗(yi)传(chuan)性罕见病,已列入我(wo)国第一批(pi)罕见病目(mu)录,本(ben)品获(huo)批(pi)上市填补了(le)我(wo)国此类(lei)患者的用药空白。

24.艾度(du)硫酸酯酶(mei)β注射(she)液,为国(guo)内首个用(yong)(yong)于罕见(jian)病黏多(duo)糖贮积症(zheng)Ⅱ型(MPS Ⅱ,亨特综合征)的酶(mei)替代治(zhi)疗药物。黏多(duo)糖贮积症(zheng)Ⅱ型是一种严重危及(ji)生命且国(guo)内尚无有效(xiao)治(zhi)疗手段的遗(yi)传性罕见(jian)病,已列入我(wo)国(guo)第一批罕见(jian)病目录(lu),本品获批上市填补了我(wo)国(guo)此类患者的用(yong)(yong)药空(kong)白(bai)。

体内诊断(duan)试剂(ji):

25.重组结(jie)(jie)核(he)杆(gan)菌(jun)融合蛋白(EC),适用于6月(yue)龄及以(yi)上(shang)婴儿、儿童及65周岁以(yi)下成人结(jie)(jie)核(he)杆(gan)菌(jun)感染(ran)诊(zhen)断(duan),并可用于辅助结(jie)(jie)核(he)病的临床诊(zhen)断(duan),为(wei)全球首(shou)个用于鉴别(bie)卡介苗(miao)接种与(yu)结(jie)(jie)核(he)杆(gan)菌(jun)感染(ran)的体(ti)内诊(zhen)断(duan)产品,其获(huo)批上(shang)市为(wei)临床鉴别(bie)诊(zhen)断(duan)提供了新的手段。

预防用生物制(zhi)品(pin)(疫苗):

26.鼻喷(pen)冻干流感减毒(du)活疫苗:为国内首家以鼻喷(pen)途径(jing)接种(zhong)的疫苗,适用(yong)于3(36月龄(ling))~17岁人(ren)群用(yong)于预防由疫苗相关型别的流感病(bing)毒(du)引(yin)起的流行性感冒,接种(zhong)后可刺激机体产生抗流感病(bing)毒(du)的免疫力。

中药新药:

27.桑枝(zhi)总生物碱片,其主要成分为桑枝(zhi)中提取得(de)到的桑枝(zhi)总生物碱,是(shi)近10年来首(shou)个获(huo)批(pi)上(shang)市的抗(kang)糖(tang)尿(niao)病中药新药,适用(yong)于配合饮食控(kong)制及运动、治(zhi)疗(liao)2型(xing)糖(tang)尿(niao)病。本(ben)品可有(you)效(xiao)降低2型(xing)糖(tang)尿(niao)病受试者(zhe)糖(tang)化血红蛋白水平,其获(huo)批(pi)上(shang)市为2型(xing)糖(tang)尿(niao)病患者(zhe)提供新的治(zhi)疗(liao)选择(ze)。

28.筋(jin)骨(gu)止痛凝胶(jiao),为醋(cu)延胡索(suo)、川芎等12种药(yao)味(wei)组成的(de)(de)中药(yao)复(fu)方新药(yao),适用(yong)于膝(xi)骨(gu)关(guan)节炎肾(shen)虚筋(jin)脉瘀滞(zhi)证的(de)(de)症状改善,具(ju)有“活血理气,祛(qu)风除湿,通(tong)(tong)络止痛”的(de)(de)功效。本品为外用(yong)凝胶(jiao)制剂,药(yao)物中各成分通(tong)(tong)过透皮吸(xi)收(shou)而发(fa)挥(hui)作用(yong),可避免肠(chang)胃吸(xi)收(shou)和肝脏(zang)首过代(dai)谢,其获(huo)批上市可为膝(xi)关(guan)节骨(gu)性关(guan)节炎患者提供新的(de)(de)治疗选择。

29.连花清咳片,为(wei)麻黄、桑白皮等(deng)15种药(yao)味组成的(de)中药(yao)新(xin)药(yao),适用(yong)于治疗(liao)急性气(qi)(qi)管(guan)(guan)-支(zhi)气(qi)(qi)管(guan)(guan)炎痰热壅(yong)肺证(zheng)引起的(de)咳嗽、咳痰等(deng),具有(you)“宣肺泄热,化痰止咳”的(de)功效,其获批上市可(ke)为(wei)急性气(qi)(qi)管(guan)(guan)-支(zhi)气(qi)(qi)管(guan)(guan)炎患者(zhe)提供新(xin)的(de)治疗(liao)选择(ze)。

四、全(quan)力(li)做好(hao)应急审评工作

(一)加强统一领(ling)导(dao),制定工作程序

按照国家药监局党组(zu)(zu)关于(yu)疫(yi)情(qing)防(fang)控应(ying)急审(shen)(shen)评(ping)(ping)审(shen)(shen)批工(gong)(gong)作(zuo)(zuo)部署,药审(shen)(shen)中(zhong)心(xin)闻令而动(dong),一是充分(fen)发挥集体决策作(zuo)(zuo)用,迅速成(cheng)立抗新型(xing)冠(guan)(guan)状病毒(du)药物(wu)特别(bie)审(shen)(shen)评(ping)(ping)领(ling)导(dao)小(xiao)(xiao)组(zu)(zu),抽调16个(ge)部门148名骨干(gan)力量(liang)为工(gong)(gong)作(zuo)(zuo)小(xiao)(xiao)组(zu)(zu)成(cheng)员,先后召开(kai)特别(bie)审(shen)(shen)评(ping)(ping)领(ling)导(dao)小(xiao)(xiao)组(zu)(zu)会议(yi)6次(ci)和(he)领(ling)导(dao)小(xiao)(xiao)组(zu)(zu)专题会18次(ci),明晰工(gong)(gong)作(zuo)(zuo)原则,优化工(gong)(gong)作(zuo)(zuo)流程(cheng),及(ji)时研究解决应(ying)急审(shen)(shen)评(ping)(ping)过程(cheng)中(zhong)遇到的(de)问题,保(bao)证工(gong)(gong)作(zuo)(zuo)顺利推进、有(you)序(xu)(xu)开(kai)展(zhan)。二是制定工(gong)(gong)作(zuo)(zuo)程(cheng)序(xu)(xu),形成(cheng)1个(ge)方案、2个(ge)程(cheng)序(xu)(xu)、1个(ge)规(gui)(gui)(gui)范,即《药审(shen)(shen)中(zhong)心(xin)抗新型(xing)冠(guan)(guan)状病毒(du)药物(wu)特别(bie)审(shen)(shen)评(ping)(ping)工(gong)(gong)作(zuo)(zuo)方案》《关于(yu)新型(xing)冠(guan)(guan)状病毒(du)(2019-nCoV)药物(wu)立项申请评(ping)(ping)议(yi)工(gong)(gong)作(zuo)(zuo)程(cheng)序(xu)(xu)》《关于(yu)新型(xing)冠(guan)(guan)状病毒(du)(2019-nCoV)药物(wu)特别(bie)专家组(zu)(zu)评(ping)(ping)估(gu)和(he)审(shen)(shen)核(he)工(gong)(gong)作(zuo)(zuo)程(cheng)序(xu)(xu)》《国家药监局抗新型(xing)冠(guan)(guan)状病毒(du)药物(wu)专家会议(yi)管理规(gui)(gui)(gui)范》。三是严格落实“安全守底线、疗(liao)效有(you)证据、质量(liang)能(neng)保(bao)证、审(shen)(shen)评(ping)(ping)超常(chang)规(gui)(gui)(gui)”的(de)工(gong)(gong)作(zuo)(zuo)要求,按照工(gong)(gong)作(zuo)(zuo)程(cheng)序(xu)(xu),依法依规(gui)(gui)(gui)、科学规(gui)(gui)(gui)范审(shen)(shen)评(ping)(ping),标准不降,加速审(shen)(shen)批。

(二)发挥专家(jia)作用,解决技术(shu)难题

一是(shi)(shi)组(zu)(zu)建特别(bie)专家(jia)(jia)组(zu)(zu)。按照《国(guo)家(jia)(jia)食品(pin)(pin)药(yao)品(pin)(pin)监督(du)管理(li)局(ju)药(yao)品(pin)(pin)特别(bie)审批程(cheng)序》(原国(guo)家(jia)(jia)食品(pin)(pin)药(yao)品(pin)(pin)监督(du)管理(li)局(ju)令(ling)第21号)规(gui)定和(he)国(guo)家(jia)(jia)药(yao)监局(ju)新(xin)型冠(guan)状病毒感染(ran)肺(fei)炎疫情应对工作组(zu)(zu)药(yao)品(pin)(pin)组(zu)(zu)的(de)(de)决定,药(yao)审中(zhong)心先后(hou)遴选出(chu)多(duo)位院士(shi)和(he)知名专家(jia)(jia)组(zu)(zu)成了特别(bie)专家(jia)(jia)组(zu)(zu),经国(guo)家(jia)(jia)药(yao)监局(ju)批准(zhun)后(hou)开展工作。遇到新(xin)的(de)(de)技术难点问题时(shi),听取专家(jia)(jia)意见建议后(hou),由专家(jia)(jia)投票表(biao)决。二是(shi)(shi)注重(zhong)发(fa)挥专家(jia)(jia)技术支(zhi)撑作用。通(tong)过专家(jia)(jia)研讨会和(he)专家(jia)(jia)咨询会解决特定技术问题,例如针对mRNA新(xin)冠(guan)病毒疫苗在研发(fa)上存在的(de)(de)难点和(he)潜(qian)在的(de)(de)风险,药(yao)审中(zhong)心组(zu)(zu)织专家(jia)(jia)形成技术指导(dao)原则,以指导(dao)相关企业(ye)的(de)(de)研发(fa)。

(三)实(shi)时高(gao)(gao)效(xiao)沟通,提高(gao)(gao)研发进(jin)度

一是遵循“早期(qi)介入(ru)、持(chi)续(xu)跟(gen)进(jin)、主(zhu)动(dong)(dong)服务”的工作(zuo)要求(qiu),第一时间组(zu)(zu)织审(shen)评力量对咨询品(pin)种或(huo)注(zhu)册申(shen)请(qing)(qing)立项的科学(xue)性(xing)和可行(xing)性(xing)进(jin)行(xing)评议,并(bing)在24小时内与申(shen)请(qing)(qing)人进(jin)行(xing)沟通(tong)交(jiao)流,保证(zheng)申(shen)请(qing)(qing)人尽(jin)快提交(jiao)特别(bie)审(shen)批(pi)注(zhu)册申(shen)请(qing)(qing)。二(er)是加强国际合作(zuo)。积(ji)极(ji)参加世界卫(wei)生组(zu)(zu)织(WHO)、国际药品(pin)监管机构(gou)联盟(ICMRA)等组(zu)(zu)织召开(kai)的视频电话会议,共同探(tan)讨研发审(shen)评标(biao)准,了(le)解新冠病毒疫苗研发信(xin)息,指导推动(dong)(dong)研发企业(ye)赴(fu)国外开(kai)展Ⅲ期(qi)临床试验。

(四(si))探索研审联动(dong),坚持(chi)科学审评

一是探索建立研(yan)发审(shen)(shen)评(ping)(ping)联动工作(zuo)机(ji)制。边研(yan)发、边提交、边审(shen)(shen)评(ping)(ping),为新冠(guan)病毒(du)(du)疫苗(miao)研(yan)发争取到了(le)宝贵(gui)时(shi)间,确保新冠(guan)病毒(du)(du)疫苗(miao)等(deng)研(yan)发走在世界前列。通(tong)过这种(zhong)工作(zuo)机(ji)制,大(da)大(da)缩短了(le)审(shen)(shen)评(ping)(ping)时(shi)间。二是建立技(ji)术标准(zhun)体系。针对新冠(guan)病毒(du)(du)的特点,及(ji)时(shi)制定新冠(guan)病毒(du)(du)疫苗(miao)、新冠(guan)肺炎治疗药(yao)物研(yan)发技(ji)术指(zhi)导原则等(deng)28个技(ji)术文件,指(zhi)导企(qi)业高标准(zhun)研(yan)发,少走弯路,科(ke)学开展(zhan)审(shen)(shen)评(ping)(ping)。

 五(wu)、鼓励中药传承创(chuang)新发展(zhan)

贯彻(che)落实(shi)习(xi)近平总书记关于中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)重要指(zhi)(zhi)(zhi)(zhi)示(shi)精(jing)(jing)神、《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)共中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)央(yang) 国务院关于促(cu)进(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)传(chuan)承创(chuang)新(xin)(xin)发(fa)(fa)展(zhan)(zhan)的(de)(de)意见》及国家(jia)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)局要求(qiu),药(yao)(yao)(yao)(yao)(yao)(yao)(yao)审中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)心(xin)从改革(ge)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)分类、健(jian)全中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)等(deng)(deng)各方(fang)面积极鼓励中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)守正创(chuang)新(xin)(xin)。一(yi)是(shi)(shi)推(tui)动(dong)(dong)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)传(chuan)承发(fa)(fa)展(zhan)(zhan)。起草并由国家(jia)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)局发(fa)(fa)布《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)分类及申(shen)(shen)报资(zi)(zi)料(liao)要求(qiu)》,丰富古代经(jing)典(dian)名方(fang)复方(fang)制(zhi)(zhi)(zhi)剂(ji)的(de)(de)范围,促(cu)进(jin)古代经(jing)典(dian)名方(fang)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)制(zhi)(zhi)(zhi)剂(ji)研(yan)(yan)(yan)(yan)(yan)发(fa)(fa),推(tui)动(dong)(dong)其向新(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)转化(hua)。二是(shi)(shi)建立完善符(fu)(fu)合中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)点(dian)的(de)(de)质(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)体(ti)系(xi)(xi)。遵(zun)循中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)点(dian)和(he)(he)研(yan)(yan)(yan)(yan)(yan)发(fa)(fa)规律,将中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)独特(te)(te)(te)的(de)(de)理论体(ti)系(xi)(xi)和(he)(he)实(shi)践特(te)(te)(te)点(dian)、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)剂(ji)质(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)特(te)(te)(te)点(dian)与药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)质(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)的(de)(de)一(yi)般(ban)要求(qiu)有机结(jie)合,研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)构建完善符(fu)(fu)合中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)剂(ji)特(te)(te)(te)点(dian)的(de)(de)质(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)方(fang)法和(he)(he)策略,制(zhi)(zhi)(zhi)定《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)(yong)饮片(pian)炮制(zhi)(zhi)(zhi)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(试(shi)行(xing)(xing)(xing)(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)量(liang)(liang)标准研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(试(shi)行(xing)(xing)(xing)(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)制(zhi)(zhi)(zhi)剂(ji)生产工(gong)(gong)艺研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(试(shi)行(xing)(xing)(xing)(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)生物效应(ying)检测研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(试(shi)行(xing)(xing)(xing)(xing))》等(deng)(deng)8个(ge)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)。三是(shi)(shi)健(jian)全符(fu)(fu)合中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)点(dian)的(de)(de)审评(ping)体(ti)系(xi)(xi)。引入新(xin)(xin)工(gong)(gong)具、新(xin)(xin)方(fang)法、新(xin)(xin)标准用(yong)(yong)(yong)(yong)于中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)疗(liao)效评(ping)价,细化(hua)申(shen)(shen)报资(zi)(zi)料(liao)要求(qiu),制(zhi)(zhi)(zhi)定《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)(yong)于慢性便秘临床(chuang)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)(yong)于糖尿病肾病临床(chuang)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)》等(deng)(deng)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze),探索构建中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)理论、人用(yong)(yong)(yong)(yong)经(jing)验和(he)(he)临床(chuang)试(shi)验相结(jie)合的(de)(de)审评(ping)证据体(ti)系(xi)(xi)。四(si)是(shi)(shi)全力(li)做好(hao)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)别审评(ping)工(gong)(gong)作(zuo)。充分发(fa)(fa)扬抗疫精(jing)(jing)神,制(zhi)(zhi)(zhi)定了(le)《用(yong)(yong)(yong)(yong)于新(xin)(xin)冠肺(fei)炎(yan)(yan)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)申(shen)(shen)请(qing)特(te)(te)(te)别审批申(shen)(shen)报资(zi)(zi)料(liao)要求(qiu)(试(shi)行(xing)(xing)(xing)(xing))》《用(yong)(yong)(yong)(yong)于新(xin)(xin)冠肺(fei)炎(yan)(yan)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)申(shen)(shen)请(qing)特(te)(te)(te)别审批技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(试(shi)行(xing)(xing)(xing)(xing))》等(deng)(deng),指(zhi)(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)(dao)(dao)应(ying)急状(zhuang)态下的(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)审评(ping)。截至2020年12月31日,“三方(fang)”中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)的(de)(de)清肺(fei)排毒颗粒、化(hua)湿败毒颗粒的(de)(de)IND申(shen)(shen)请(qing)已(yi)获批准,“三药(yao)(yao)(yao)(yao)(yao)(yao)(yao)”连花(hua)清瘟(wen)颗粒/胶囊、金花(hua)清感颗粒、血(xue)必净(jing)注(zhu)射液获批增加用(yong)(yong)(yong)(yong)于治(zhi)疗(liao)新(xin)(xin)冠肺(fei)炎(yan)(yan)的(de)(de)适应(ying)症(zheng)。五(wu)是(shi)(shi)赴武汉开(kai)(kai)(kai)展(zhan)(zhan)实(shi)地(di)调研(yan)(yan)(yan)(yan)(yan)和(he)(he)座(zuo)谈,持续推(tui)进(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)管(guan)科学“以临床(chuang)价值为导(dao)(dao)(dao)(dao)(dao)(dao)向的(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)安全性评(ping)价研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)”课(ke)题研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)。六(liu)是(shi)(shi)开(kai)(kai)(kai)展(zhan)(zhan)援(yuan)疆(jiang)援(yuan)藏工(gong)(gong)作(zuo),赴西藏开(kai)(kai)(kai)展(zhan)(zhan)实(shi)地(di)调研(yan)(yan)(yan)(yan)(yan)、与新(xin)(xin)疆(jiang)维吾尔自治(zhi)区药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)监(jian)督(du)管(guan)理局召开(kai)(kai)(kai)线上座(zuo)谈交流会,支(zhi)持民族(zu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)发(fa)(fa)展(zhan)(zhan)。

  六、加(jia)强(qiang)《药品(pin)注册管理办法(fa)》配套(tao)文件制修(xiu)订

新(xin)修(xiu)订(ding)的(de)《药(yao)品注册(ce)管(guan)(guan)(guan)理(li)办(ban)法(fa)》是贯彻党中央、国(guo)务(wu)院审(shen)评审(shen)批(pi)制度改革精神和(he)落实新(xin)修(xiu)订(ding)《药(yao)品管(guan)(guan)(guan)理(li)法(fa)》的(de)重要(yao)(yao)规章,考虑到药(yao)品注册(ce)管(guan)(guan)(guan)理(li)中的(de)具体技术(shu)要(yao)(yao)求(qiu),需(xu)要(yao)(yao)跟随技术(shu)发展的(de)脚步不(bu)断(duan)调整完善,在规章中不(bu)适宜作(zuo)出具体的(de)规定,因此这些具体技术(shu)要(yao)(yao)求(qiu)在《药(yao)品注册(ce)管(guan)(guan)(guan)理(li)办(ban)法(fa)》发布后(hou),以(yi)配套(tao)文件(jian)、技术(shu)指导(dao)原(yuan)则(ze)等(deng)形式(shi)发布,既能更(geng)好(hao)地顺应药(yao)品研发的(de)科学(xue)规律(lv),也能确保(bao)新(xin)旧《药(yao)品注册(ce)管(guan)(guan)(guan)理(li)办(ban)法(fa)》的(de)平稳过渡和(he)新(xin)《药(yao)品注册(ce)管(guan)(guan)(guan)理(li)办(ban)法(fa)》的(de)顺利实施(shi)。

根据国家(jia)局部(bu)署,药审中心(xin)统筹(chou)协调,加大配套(tao)文件(jian)的制修(xiu)订力度,成立课题组,对重点(dian)难点(dian)问题开展调研(yan)攻关,充(chong)分听取专家(jia)、业界意见,力求达成共识(shi),共参与(yu)了(le)48个配套(tao)文件(jian)制修(xiu)订工作(zuo)(zuo),其(qi)中牵头起草配套(tao)文件(jian)30个。自开展工作(zuo)(zuo)以来(lai),已基本完(wan)成配套(tao)文件(jian)公开征求意见工作(zuo)(zuo),部(bu)分文件(jian)已经国家(jia)局审核(he)同意后发布实(shi)施(shi),有(you)效确保(bao)了(le)各项审评任务不断、不散、不乱,新旧注册相关规定的顺利过渡(du)和(he)实(shi)施(shi)。

 七、加快审评技术标准体系建设

在药品审评和(he)研发过程中(zhong),指(zhi)(zhi)导(dao)原(yuan)则兼(jian)具(ju)监管依据和(he)技术要求(qiu)的(de)双重职能。《药品注册管理(li)办法(fa)(fa)》明(ming)确(que)从事药物研制(zhi)和(he)药品注册活(huo)动,应(ying)当(dang)遵守有(you)关法(fa)(fa)律、法(fa)(fa)规、规章、标准和(he)规范(fan);药审中(zhong)心等专业(ye)技术机构,应(ying)当(dang)根据科(ke)学进展、行业(ye)发展实(shi)际(ji)和(he)药品监督管理(li)工作(zuo)需要制(zhi)定技术指(zhi)(zhi)导(dao)原(yuan)则和(he)程序(xu),并(bing)向(xiang)社会公布(bu)。

药(yao)(yao)(yao)(yao)(yao)品(pin)技术指(zhi)(zhi)导(dao)(dao)原则(ze)体系的(de)(de)建立与完善,是落(luo)实“四个(ge)最严”要求(qiu)(qiu)的(de)(de)最好实践,是药(yao)(yao)(yao)(yao)(yao)审中心(xin)(xin)推(tui)进审评体系和审评能力现(xian)代(dai)化的(de)(de)重(zhong)要举措(cuo)。药(yao)(yao)(yao)(yao)(yao)审中心(xin)(xin)通过“定(ding)标(biao)准(zhun)、定(ding)程序(xu)、定(ding)计划”三步(bu)走的(de)(de)方式,统筹规(gui)划以指(zhi)(zhi)导(dao)(dao)原则(ze)为核心(xin)(xin)的(de)(de)审评标(biao)准(zhun)体系建设,围(wei)绕药(yao)(yao)(yao)(yao)(yao)品(pin)研发需求(qiu)(qiu)和鼓励(li)创(chuang)新的(de)(de)原则(ze),对标(biao)国际先进监(jian)管机构技术标(biao)准(zhun),加(jia)大指(zhi)(zhi)导(dao)(dao)原则(ze)制(zhi)定(ding)和公开力度。2020年共开展了(le)119个(ge)技术指(zhi)(zhi)导(dao)(dao)原则(ze)制(zhi)修订工(gong)作,根据《国家药(yao)(yao)(yao)(yao)(yao)监(jian)局综合司关(guan)于印(yin)发药(yao)(yao)(yao)(yao)(yao)品(pin)技术指(zhi)(zhi)导(dao)(dao)原则(ze)发布(bu)程序(xu)的(de)(de)通知(zhi)》(药(yao)(yao)(yao)(yao)(yao)监(jian)综药(yao)(yao)(yao)(yao)(yao)管〔2020〕9号)要求(qiu)(qiu),截(jie)至2020年12月(yue)31日,药(yao)(yao)(yao)(yao)(yao)审中心(xin)(xin)已经国家药(yao)(yao)(yao)(yao)(yao)监(jian)局审查同意发布(bu)了(le)71个(ge)指(zhi)(zhi)导(dao)(dao)原则(ze),详见(jian)附(fu)件(jian)6。

在(zai)应(ying)(ying)对新(xin)(xin)型(xing)(xing)冠状病(bing)毒肺炎、促进新(xin)(xin)冠病(bing)毒疫苗(miao)和(he)(he)新(xin)(xin)冠肺炎治疗药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)的研(yan)(yan)(yan)(yan)(yan)发(fa)和(he)(he)审(shen)(shen)(shen)评质(zhi)(zhi)量(liang)、速(su)度(du)方(fang)面,药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)审(shen)(shen)(shen)中(zhong)心(xin)发(fa)布了(le)(le)《新(xin)(xin)型(xing)(xing)冠状病(bing)毒预(yu)防用(yong)疫苗(miao)研(yan)(yan)(yan)(yan)(yan)发(fa)技(ji)(ji)术(shu)(shu)(shu)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(试(shi)行(xing)(xing))》等7个(ge)(ge)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则;在(zai)着(zhe)力提升(sheng)中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)材质(zhi)(zhi)量(liang)研(yan)(yan)(yan)(yan)(yan)究(jiu),鼓励中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)研(yan)(yan)(yan)(yan)(yan)发(fa)与创(chuang)新(xin)(xin)方(fang)面,发(fa)布了(le)(le)《中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)材质(zhi)(zhi)量(liang)控制(zhi)(zhi)(zhi)研(yan)(yan)(yan)(yan)(yan)究(jiu)技(ji)(ji)术(shu)(shu)(shu)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(试(shi)行(xing)(xing))》《中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)制(zhi)(zhi)(zhi)剂(ji)生产工艺研(yan)(yan)(yan)(yan)(yan)究(jiu)技(ji)(ji)术(shu)(shu)(shu)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(试(shi)行(xing)(xing))》《中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)于慢(man)性(xing)便秘临(lin)床(chuang)研(yan)(yan)(yan)(yan)(yan)究(jiu)技(ji)(ji)术(shu)(shu)(shu)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则》等10个(ge)(ge)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则;在(zai)鼓励儿(er)童药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)研(yan)(yan)(yan)(yan)(yan)发(fa)方(fang)面,发(fa)布了(le)(le)《真实世(shi)界研(yan)(yan)(yan)(yan)(yan)究(jiu)支持(chi)儿(er)童药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)研(yan)(yan)(yan)(yan)(yan)发(fa)与审(shen)(shen)(shen)评的技(ji)(ji)术(shu)(shu)(shu)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(试(shi)行(xing)(xing))》等3个(ge)(ge)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则;在(zai)支持(chi)抗(kang)(kang)(kang)(kang)肿(zhong)瘤(liu)(liu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)研(yan)(yan)(yan)(yan)(yan)发(fa),进一步满足申请人对具体(ti)抗(kang)(kang)(kang)(kang)肿(zhong)瘤(liu)(liu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)的个(ge)(ge)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则需求方(fang)面,发(fa)布了(le)(le)《抗(kang)(kang)(kang)(kang)肿(zhong)瘤(liu)(liu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)联合治疗临(lin)床(chuang)试(shi)验技(ji)(ji)术(shu)(shu)(shu)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则》《注(zhu)射(she)用(yong)曲妥珠(zhu)单(dan)抗(kang)(kang)(kang)(kang)生物(wu)(wu)类似药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)临(lin)床(chuang)试(shi)验指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则》等22个(ge)(ge)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则;在(zai)提高(gao)仿制(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang),推进仿制(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)一致(zhi)(zhi)性(xing)评价(jia)(jia)方(fang)面,规范审(shen)(shen)(shen)评标(biao)(biao)准和(he)(he)尺(chi)度(du),发(fa)布了(le)(le)《化(hua)学药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)注(zhu)射(she)剂(ji)仿制(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang)和(he)(he)疗效一致(zhi)(zhi)性(xing)评价(jia)(jia)技(ji)(ji)术(shu)(shu)(shu)要求》《化(hua)学药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)注(zhu)射(she)剂(ji)(特殊注(zhu)射(she)剂(ji))仿制(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang)和(he)(he)疗效一致(zhi)(zhi)性(xing)评价(jia)(jia)技(ji)(ji)术(shu)(shu)(shu)要求》等9个(ge)(ge)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则。这些(xie)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则覆盖新(xin)(xin)冠应(ying)(ying)急审(shen)(shen)(shen)评标(biao)(biao)准、儿(er)童用(yong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)、中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)民(min)族(zu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)技(ji)(ji)术(shu)(shu)(shu)标(biao)(biao)准体(ti)系(xi)、抗(kang)(kang)(kang)(kang)肿(zhong)瘤(liu)(liu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)研(yan)(yan)(yan)(yan)(yan)发(fa)及(ji)仿制(zhi)(zhi)(zhi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)研(yan)(yan)(yan)(yan)(yan)发(fa)等热点难点问(wen)题,持(chi)续完善药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)技(ji)(ji)术(shu)(shu)(shu)指导(dao)(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则体(ti)系(xi),有(you)效推动药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)研(yan)(yan)(yan)(yan)(yan)发(fa)创(chuang)新(xin)(xin),不断优化(hua)统一审(shen)(shen)(shen)评尺(chi)度(du),大力提升(sheng)审(shen)(shen)(shen)评质(zhi)(zhi)量(liang)和(he)(he)效率,显(xian)著(zhu)减少审(shen)(shen)(shen)评自(zi)由裁(cai)量(liang)权。

 八、持续深化药品审评(ping)审批制度改革(ge)

(一)加快境外已(yi)上市临床急需新药审评

深(shen)入贯(guan)彻国(guo)(guo)(guo)务(wu)院(yuan)常(chang)务(wu)会议精神,落实加快境外(wai)已(yi)上(shang)(shang)市临(lin)床(chuang)急(ji)需(xu)新(xin)药(yao)审评要求(qiu),在(zai)确定了(le)第一(yi)二(er)批(pi)(pi)74个(ge)(ge)品种名(ming)单的基础上(shang)(shang),国(guo)(guo)(guo)家(jia)(jia)药(yao)监(jian)局(ju)(ju)、国(guo)(guo)(guo)家(jia)(jia)卫生健康委组织有关专家(jia)(jia)研究论证,遴选临(lin)床(chuang)急(ji)需(xu)新(xin)药(yao)品种,药(yao)审中心发布(bu)了(le)第三(san)批(pi)(pi)7个(ge)(ge)品种名(ming)单。对(dui)于符合《国(guo)(guo)(guo)家(jia)(jia)药(yao)品监(jian)督管理局(ju)(ju) 国(guo)(guo)(guo)家(jia)(jia)卫生健康委员(yuan)会关于临(lin)床(chuang)急(ji)需(xu)境外(wai)新(xin)药(yao)审评审批(pi)(pi)相关事(shi)宜的公(gong)告》(2018年(nian)第79号)规(gui)定情形的品种,国(guo)(guo)(guo)家(jia)(jia)药(yao)监(jian)局(ju)(ju)会同国(guo)(guo)(guo)家(jia)(jia)卫生健康委已(yi)组织进行了(le)充(chong)分遴选,基本解决了(le)临(lin)床(chuang)急(ji)需(xu)境外(wai)已(yi)上(shang)(shang)市新(xin)药(yao)在(zai)我国(guo)(guo)(guo)上(shang)(shang)市速度(du)较慢的问题,进一(yi)步提高了(le)公(gong)众(zhong)用药(yao)的可及性。

2020年,药审中心(xin)完(wan)成(cheng)了13个(ge)用于治疗(liao)罕见(jian)病的、临(lin)床急(ji)需(xu)的药品(pin)(pin)的技术审评,均在(zai)规定时限(xian)内(nei)完(wan)成(cheng),罕见(jian)病药品(pin)(pin)在(zai)3个(ge)月(yue)之内(nei)完(wan)成(cheng)审评,其(qi)他临(lin)床急(ji)需(xu)药品(pin)(pin)在(zai)6个(ge)月(yue)之内(nei)完(wan)成(cheng)审评,大大缩短了临(lin)床急(ji)需(xu)境外(wai)新药在(zai)我国(guo)上(shang)(shang)市的时间差距。截至2020年12月(yue)31日,已发布(bu)的三批81个(ge)品(pin)(pin)种(zhong)临(lin)床急(ji)需(xu)境外(wai)已上(shang)(shang)市新药中,已有(you)38家企业的48个(ge)品(pin)(pin)种(zhong)提出注(zhu)册申请,其(qi)中39个(ge)品(pin)(pin)种(zhong)已获批上(shang)(shang)市或(huo)完(wan)成(cheng)审评,100%在(zai)时限(xian)内(nei)完(wan)成(cheng)审评工作,详见(jian)附件7。

(二)加速(su)推动仿(fang)制药一致性(xing)评价工作

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

一(yi)(yi)是在(zai)口服(fu)固体(ti)制(zhi)(zhi)剂(ji)(ji)一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)工(gong)作的(de)(de)(de)(de)基础上,积极推进注(zhu)(zhu)射(she)(she)剂(ji)(ji)一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)工(gong)作。国家药(yao)(yao)监局于5月(yue)12日发(fa)布(bu)《关于开(kai)展(zhan)化(hua)(hua)学药(yao)(yao)品注(zhu)(zhu)射(she)(she)剂(ji)(ji)仿(fang)(fang)(fang)制(zhi)(zhi)药(yao)(yao)质(zhi)量(liang)和(he)疗效一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)工(gong)作的(de)(de)(de)(de)公(gong)告(gao)》(2020年第(di)62号),正(zheng)式启(qi)(qi)动注(zhu)(zhu)射(she)(she)剂(ji)(ji)一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)工(gong)作。药(yao)(yao)审(shen)中心发(fa)布(bu)《化(hua)(hua)学药(yao)(yao)品注(zhu)(zhu)射(she)(she)剂(ji)(ji)仿(fang)(fang)(fang)制(zhi)(zhi)药(yao)(yao)质(zhi)量(liang)和(he)疗效一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)技术要(yao)求(qiu)》《化(hua)(hua)学药(yao)(yao)品注(zhu)(zhu)射(she)(she)剂(ji)(ji)仿(fang)(fang)(fang)制(zhi)(zhi)药(yao)(yao)质(zhi)量(liang)和(he)疗效一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)申报资料要(yao)求(qiu)》和(he)《化(hua)(hua)学药(yao)(yao)品注(zhu)(zhu)射(she)(she)剂(ji)(ji)(特殊注(zhu)(zhu)射(she)(she)剂(ji)(ji))仿(fang)(fang)(fang)制(zhi)(zhi)药(yao)(yao)质(zhi)量(liang)和(he)疗效一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)技术要(yao)求(qiu)》等技术要(yao)求(qiu)。针对正(zheng)式启(qi)(qi)动前(qian)已有620件待审(shen)评(ping)(ping)(ping)(ping)的(de)(de)(de)(de)注(zhu)(zhu)射(she)(she)剂(ji)(ji)一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)申请(qing),药(yao)(yao)审(shen)中心成立专项审(shen)评(ping)(ping)(ping)(ping)工(gong)作组,采取细化(hua)(hua)分类处理措施,严(yan)格执行(xing)一(yi)(yi)次性(xing)(xing)(xing)(xing)发(fa)补,明(ming)确(que)注(zhu)(zhu)射(she)(she)剂(ji)(ji)一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)注(zhu)(zhu)册(ce)检查(cha)的(de)(de)(de)(de)随机原(yuan)则,加快审(shen)评(ping)(ping)(ping)(ping)速(su)度,在(zai)不到5个月(yue)的(de)(de)(de)(de)时间内完成了620件品种(zhong)的(de)(de)(de)(de)审(shen)评(ping)(ping)(ping)(ping),一(yi)(yi)致性(xing)(xing)(xing)(xing)评(ping)(ping)(ping)(ping)价(jia)(jia)(jia)(jia)按(an)时限审(shen)评(ping)(ping)(ping)(ping)已进入常(chang)态化(hua)(hua)。

二是继续规(gui)范参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)遴(lin)选工(gong)(gong)作(zuo)(zuo)(zuo),强化服务(wu)与指导(dao)。药审(shen)中心(xin)发布《化学仿制(zhi)(zhi)药参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)遴(lin)选申请(qing)资(zi)料要求》(药审(shen)中心(xin)通(tong)(tong)告2020年(nian)第(di)32号),进(jin)一(yi)步(bu)强调申请(qing)人(ren)的自(zi)查(cha)环(huan)节,提高参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)遴(lin)选工(gong)(gong)作(zuo)(zuo)(zuo)效率。通(tong)(tong)过进(jin)一(yi)步(bu)规(gui)范内部审(shen)核、专(zhuan)家委(wei)员会审(shen)核等流程,2020年(nian)优化了参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)遴(lin)选工(gong)(gong)作(zuo)(zuo)(zuo)。自(zi)2017年(nian)8月开展一(yi)致(zhi)性评(ping)价工(gong)(gong)作(zuo)(zuo)(zuo)以来(lai)共发布参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)目(mu)录35批,涉及3963个品规(gui)(1703个品种),其中包括注射剂(ji)(ji)参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)975个品规(gui)(405个品种)。

三(san)是加强信息公(gong)开和(he)培训。2020年7月(yue)举办线上化学仿制药(yao)注(zhu)(zhu)射剂(ji)一致性评价技术研讨(tao)会,对注(zhu)(zhu)射剂(ji)一致性评价技术要(yao)求、特殊注(zhu)(zhu)射剂(ji)技术要(yao)求、参比制剂(ji)申请资(zi)料要(yao)求等(deng)进行宣讲(jiang)。

四是(shi)持(chi)续推进生(sheng)物等效性试(shi)(shi)验(yan)备案工(gong)作。2020年(nian)化学药生(sheng)物等效性试(shi)(shi)验(yan)备案平台(tai)共(gong)收(shou)集(ji)了(le)672条记录,仿制药一致(zhi)性评价(jia)生(sheng)物等效性试(shi)(shi)验(yan)备案平台(tai)共(gong)收(shou)集(ji)了(le)292条记录。

(三)全(quan)面落实临床试(shi)验(yan)期(qi)间(jian)风险(xian)管(guan)理

为落(luo)实《药品管(guan)理(li)法(fa)》《药品注册管(guan)理(li)办(ban)法(fa)》中(zhong)有关临(lin)(lin)(lin)床试(shi)验(yan)(yan)期(qi)间(jian)安全风险(xian)(xian)管(guan)理(li)工作(zuo),药审中(zhong)心(xin)在国家药监局(ju)指(zhi)导(dao)下(xia),发(fa)布了(le)(le)《药物(wu)临(lin)(lin)(lin)床试(shi)验(yan)(yan)期(qi)间(jian)安全信息(xi)评估(gu)(gu)与(yu)管(guan)理(li)规(gui)范(试(shi)行(xing))》、《研发(fa)期(qi)间(jian)安全性(xing)更(geng)新(xin)(xin)报(bao)(bao)告管(guan)理(li)规(gui)范(试(shi)行(xing))》和《药物(wu)临(lin)(lin)(lin)床试(shi)验(yan)(yan)登记(ji)及信息(xi)公示管(guan)理(li)规(gui)范(试(shi)行(xing))》3个配套文(wen)件。为进一步加强临(lin)(lin)(lin)床试(shi)验(yan)(yan)过程的(de)安全信息(xi)监测、识别、评估(gu)(gu)和风险(xian)(xian)控制,制定了(le)(le)《药品审评中(zhong)心(xin)药物(wu)临(lin)(lin)(lin)床试(shi)验(yan)(yan)期(qi)间(jian)安全信息(xi)评估(gu)(gu)与(yu)风险(xian)(xian)管(guan)理(li)工作(zuo)程序(试(shi)行(xing))》,上线运行(xing)“临(lin)(lin)(lin)床试(shi)验(yan)(yan)期(qi)间(jian)安全风险(xian)(xian)管(guan)理(li)系统”,对临(lin)(lin)(lin)床试(shi)验(yan)(yan)期(qi)间(jian)的(de)安全信息(xi),如(ru)可疑(yi)且非预期(qi)严(yan)重不良反应(SUSAR)和研发(fa)期(qi)间(jian)安全性(xing)更(geng)新(xin)(xin)报(bao)(bao)告(DSUR)等开(kai)展全过程信息(xi)系统化的(de)风险(xian)(xian)评估(gu)(gu)。

2020年药(yao)审中心接收(shou)来(lai)(lai)自国内(nei)外的(de)SUSAR个例报(bao)(bao)告164403份(涉(she)及(ji)(ji)病例为57995例)。其中,来(lai)(lai)自中国的(de)SUSAR个例报(bao)(bao)告17243份(涉(she)及(ji)(ji)病例为4647例);接收(shou)DSUR共计1775份;完成临(lin)床试(shi)验登记2610项(xiang)(含新冠(guan)病毒疫苗和新冠(guan)肺炎治疗药(yao)物)。对18个药(yao)物临(lin)床试(shi)验中存(cun)在的(de)安(an)全性风(feng)险(xian)(xian),提出了进(jin)一步的(de)风(feng)险(xian)(xian)控(kong)制处理(li)意见,包括(kuo)一般风(feng)险(xian)(xian)控(kong)制(如修(xiu)改临(lin)床试(shi)验方案(an)、修(xiu)改知情(qing)同意书、修(xiu)改研(yan)究者手册、补充完善风(feng)险(xian)(xian)控(kong)制措施)和建议申请人主(zhu)动暂停临(lin)床试(shi)验等。

面对突如其(qi)来的(de)严重(zhong)新(xin)(xin)(xin)冠肺(fei)(fei)炎疫(yi)情,药(yao)审(shen)(shen)中心探索建立了(le)申请(qing)人进行临(lin)(lin)床试(shi)验(yan)(yan)进展信息报告机(ji)制与(yu)通道,规范了(le)相关工作程序与(yu)技(ji)术(shu)要求,发(fa)布了(le)《新(xin)(xin)(xin)冠肺(fei)(fei)炎疫(yi)情期(qi)间(jian)药(yao)物临(lin)(lin)床试(shi)验(yan)(yan)管理(li)指导原则(试(shi)行)》,制定了(le)规范统一的(de)《应急(ji)审(shen)(shen)批品种临(lin)(lin)床试(shi)验(yan)(yan)进展和(he)安全(quan)监(jian)测(ce)工作文(wen)件》。通过每日(ri)(ri)和(he)每周的(de)动态风(feng)(feng)险沟通交流,实施有(you)效的(de)风(feng)(feng)险监(jian)测(ce)与(yu)风(feng)(feng)险控制。对2020年2月2日(ri)(ri)至2020年12月31日(ri)(ri)经特别审(shen)(shen)批程序批准15个疫(yi)苗(miao)、16个生(sheng)物制品、6个化学药(yao)、2个中药(yao)的(de)临(lin)(lin)床试(shi)验(yan)(yan)共39个品种实施动态安全(quan)监(jian)测(ce),完成(cheng)了(le)应急(ji)审(shen)(shen)批新(xin)(xin)(xin)冠病毒疫(yi)苗(miao)及新(xin)(xin)(xin)冠肺(fei)(fei)炎治疗药(yao)物临(lin)(lin)床试(shi)验(yan)(yan)进展及安全(quan)性监(jian)测(ce)报告共195份。

药(yao)审中心参加(jia)《药(yao)物警戒质量管理规范》(GVP)的(de)起草工(gong)(gong)作(zuo)(zuo),撰写(xie)临床(chuang)(chuang)试验(yan)(yan)期(qi)间(jian)药(yao)物警戒相关内容和要(yao)求。完成《临床(chuang)(chuang)试验(yan)(yan)期(qi)间(jian)安全信息管理:国(guo)际(ji)医学科(ke)学组织理事会(CIOMS)VI工(gong)(gong)作(zuo)(zuo)组报(bao)告》的(de)翻译与出版工(gong)(gong)作(zuo)(zuo),召开(kai)“疫情期(qi)间(jian)临床(chuang)(chuang)试验(yan)(yan)管理及远(yuan)程智能技(ji)术(shu)应用(yong)学术(shu)交流视频会议”,探索(suo)开(kai)展远(yuan)程智能化临床(chuang)(chuang)试验(yan)(yan)的(de)安全管理工(gong)(gong)作(zuo)(zuo),稳步提升临床(chuang)(chuang)试验(yan)(yan)期(qi)间(jian)安全信息评估和风险(xian)管理能力。

(四)继(ji)续(xu)夯实审评科学(xue)基础建设

1.审评质量管(guan)理体系建设

发挥审(shen)(shen)(shen)评质(zhi)量管(guan)(guan)理体(ti)(ti)系(xi)对(dui)(dui)药(yao)(yao)(yao)(yao)品审(shen)(shen)(shen)评工(gong)作(zuo)(zuo)持(chi)续有效(xiao)运行的(de)保(bao)障作(zuo)(zuo)用。一(yi)方(fang)(fang)面是应(ying)(ying)对(dui)(dui)新(xin)法律规章(zhang)实(shi)施对(dui)(dui)审(shen)(shen)(shen)评业务工(gong)作(zuo)(zuo)带(dai)来(lai)的(de)风险(xian)和挑(tiao)战,结(jie)合(he)《药(yao)(yao)(yao)(yao)品注(zhu)册管(guan)(guan)理办法》及(ji)其配套文件要求,及(ji)时组织(zhi)对(dui)(dui)《质(zhi)量手册》等(deng)体(ti)(ti)系(xi)文件进(jin)行全面修订(ding),加(jia)强(qiang)药(yao)(yao)(yao)(yao)品审(shen)(shen)(shen)评业务与质(zhi)量体(ti)(ti)系(xi)的(de)结(jie)合(he);另一(yi)方(fang)(fang)面是应(ying)(ying)对(dui)(dui)新(xin)冠(guan)肺炎疫(yi)情对(dui)(dui)审(shen)(shen)(shen)评工(gong)作(zuo)(zuo)带(dai)来(lai)的(de)影响,通过开展(zhan)(zhan)药(yao)(yao)(yao)(yao)审(shen)(shen)(shen)中(zhong)心(xin)专项内部监(jian)督检查,充分(fen)锻(duan)炼药(yao)(yao)(yao)(yao)审(shen)(shen)(shen)中(zhong)心(xin)内审(shen)(shen)(shen)员队(dui)伍,及(ji)时发现存在(zai)的(de)风险(xian)并组织(zhi)改进(jin);同时持(chi)续开展(zhan)(zhan)年度满意度调查工(gong)作(zuo)(zuo),收(shou)集国(guo)家药(yao)(yao)(yao)(yao)监(jian)局和申(shen)请人对(dui)(dui)药(yao)(yao)(yao)(yao)审(shen)(shen)(shen)中(zhong)心(xin)在(zai)落实(shi)新(xin)注(zhu)册相(xiang)关要求、应(ying)(ying)对(dui)(dui)新(xin)冠(guan)肺炎疫(yi)情风险(xian)防(fang)控时的(de)意见和建议,为提(ti)(ti)高审(shen)(shen)(shen)评质(zhi)量和效(xiao)率提(ti)(ti)供思路,发挥质(zhi)量体(ti)(ti)系(xi)对(dui)(dui)各项工(gong)作(zuo)(zuo)的(de)支持(chi)作(zuo)(zuo)用。

2.强化(hua)审评信息化(hua)建设

为确保各项(xiang)审(shen)(shen)(shen)(shen)(shen)评(ping)改革(ge)工(gong)(gong)(gong)作执(zhi)行(xing)过程中(zhong)(zhong)的(de)规范化(hua)、标准化(hua)、数(shu)字化(hua),药(yao)(yao)(yao)审(shen)(shen)(shen)(shen)(shen)中(zhong)(zhong)心(xin)大力(li)(li)推进(jin)信(xin)息化(hua)建设,依据《药(yao)(yao)(yao)品注(zhu)(zhu)册(ce)管理(li)(li)办法》和(he)流(liu)(liu)程为导向的(de)科学(xue)管理(li)(li)体(ti)系,以药(yao)(yao)(yao)品审(shen)(shen)(shen)(shen)(shen)评(ping)业(ye)(ye)(ye)务流(liu)(liu)程为基(ji)础,立(li)足工(gong)(gong)(gong)作实际,对药(yao)(yao)(yao)品技(ji)术审(shen)(shen)(shen)(shen)(shen)评(ping)系统升级完善。新(xin)增(zeng)发补前的(de)专业(ye)(ye)(ye)审(shen)(shen)(shen)(shen)(shen)评(ping)问询(xun)和(he)发补后的(de)补充资料问询(xun)平(ping)台,优化(hua)沟通(tong)交(jiao)流(liu)(liu)系统,加(jia)(jia)强(qiang)审(shen)(shen)(shen)(shen)(shen)评(ping)期间与申(shen)请人(ren)的(de)主动沟通(tong)交(jiao)流(liu)(liu),促进(jin)审(shen)(shen)(shen)(shen)(shen)评(ping)业(ye)(ye)(ye)务工(gong)(gong)(gong)作开展(zhan);新(xin)增(zeng)异议处理(li)(li)审(shen)(shen)(shen)(shen)(shen)核(he)和(he)注(zhu)(zhu)册(ce)检(jian)验网络通(tong)道(dao),调(diao)整(zheng)优先审(shen)(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)(shen)批系统,强(qiang)化(hua)审(shen)(shen)(shen)(shen)(shen)核(he)流(liu)(liu)程可操作性,保障(zhang)审(shen)(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)(shen)批工(gong)(gong)(gong)作顺(shun)利实施。开通(tong)受理(li)(li)网上预约(yue)通(tong)道(dao),减少人(ren)员(yuan)流(liu)(liu)动聚集,有效保障(zhang)新(xin)冠(guan)肺炎(yan)疫情期间申(shen)请人(ren)受理(li)(li)业(ye)(ye)(ye)务的(de)有序(xu)办理(li)(li);增(zeng)加(jia)(jia)突破(po)性治疗药(yao)(yao)(yao)物程序(xu),为鼓励创(chuang)新(xin)和(he)加(jia)(jia)快临床急需(xu)品种(zhong)上市拓宽审(shen)(shen)(shen)(shen)(shen)评(ping)通(tong)道(dao)。通(tong)过信(xin)息化(hua)手段助(zhu)力(li)(li)药(yao)(yao)(yao)品审(shen)(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)(shen)批业(ye)(ye)(ye)务管理(li)(li),强(qiang)化(hua)网络信(xin)息安全保障(zhang),不(bu)断提(ti)升药(yao)(yao)(yao)品审(shen)(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)(shen)批工(gong)(gong)(gong)作质量和(he)效率(lv)。目前药(yao)(yao)(yao)审(shen)(shen)(shen)(shen)(shen)中(zhong)(zhong)心(xin)网站申(shen)请人(ren)之窗(chuang)实名(ming)注(zhu)(zhu)册(ce)申(shen)请企(qi)业(ye)(ye)(ye)10674家,基(ji)本实现了(le)药(yao)(yao)(yao)品、原料药(yao)(yao)(yao)、辅(fu)料、包材注(zhu)(zhu)册(ce)申(shen)请人(ren)网上业(ye)(ye)(ye)务办理(li)(li)的(de)全覆盖。

(五)积极推进流程导向科学管(guan)理体系建设

为贯(guan)彻(che)党的十九届四中、五(wu)中全(quan)会(hui)精神,加(jia)强治理(li)(li)体系(xi)(xi)、治理(li)(li)能(neng)力(li)建(jian)(jian)设,以流(liu)程导向(xiang)科(ke)(ke)学(xue)管理(li)(li)体系(xi)(xi)建(jian)(jian)设为抓(zhua)手,不断推进药(yao)(yao)(yao)品审(shen)(shen)(shen)评(ping)体系(xi)(xi)和(he)(he)审(shen)(shen)(shen)评(ping)能(neng)力(li)的现(xian)代化(hua)。按照前期工作计划(hua),药(yao)(yao)(yao)审(shen)(shen)(shen)中心(xin)已全(quan)面(mian)铺(pu)开任务受理(li)(li)、任务分配(pei)、专(zhuan)业审(shen)(shen)(shen)评(ping)、综(zong)合审(shen)(shen)(shen)评(ping)、沟通(tong)交流(liu)、专(zhuan)家咨询、书面(mian)发(fa)(fa)补、核查检验共8个(ge)(ge)子课题的科(ke)(ke)学(xue)管理(li)(li)体系(xi)(xi)试点建(jian)(jian)设,并印发(fa)(fa)《药(yao)(yao)(yao)审(shen)(shen)(shen)中心(xin)关(guan)于运行药(yao)(yao)(yao)品专(zhuan)业审(shen)(shen)(shen)评(ping)流(liu)程导向(xiang)科(ke)(ke)学(xue)管理(li)(li)体系(xi)(xi)有关(guan)问题的通(tong)知》等8个(ge)(ge)文件,制(zhi)定科(ke)(ke)学(xue)管理(li)(li)体系(xi)(xi)制(zhi)度制(zhi)修订计划(hua)(含28项(xiang)制(zhi)度),截至(zhi)2020年(nian)12月31日已完(wan)成(cheng)14项(xiang)。注重(zhong)试点建(jian)(jian)设成(cheng)果的信息化(hua),将各项(xiang)措(cuo)施(shi)纳入审(shen)(shen)(shen)评(ping)信息系(xi)(xi)统,增强措(cuo)施(shi)执行的刚性约束,提(ti)高(gao)了(le)科(ke)(ke)学(xue)监管和(he)(he)智慧审(shen)(shen)(shen)评(ping)能(neng)力(li)。

形成按(an)季度汇报机(ji)制(zhi),定期组(zu)织汇报试点运(yun)行(xing)情况。建(jian)立了(le)改(gai)革措施管(guan)理(li)台账,纳(na)入了(le)58项需要(yao)监督(du)的改(gai)革措施,按(an)月度对(dui)(dui)每(mei)项改(gai)革措施实施的责任落实、进(jin)展情况、新问(wen)题(ti)(ti)和解决建(jian)议予(yu)以一体(ti)(ti)化(hua)动态管(guan)理(li)。召(zhao)开了(le)试点推(tui)进(jin)座谈会(hui)、子课题(ti)(ti)结(jie)题(ti)(ti)座谈会(hui),对(dui)(dui)各子课题(ti)(ti)试点进(jin)度、成效(xiao)、问(wen)题(ti)(ti)等进(jin)行(xing)总结(jie)分析。建(jian)立了(le)促进(jin)试点建(jian)设的长效(xiao)运(yun)行(xing)机(ji)制(zhi),常态化(hua)、一体(ti)(ti)化(hua)推(tui)进(jin)科学(xue)审评(ping)、高效(xiao)审评(ping)和廉洁审评(ping)。

(六)持(chi)续开展ICH工作

切实(shi)推(tui)进(jin)我国(guo)(guo)药品审(shen)评审(shen)批(pi)体(ti)系与(yu)国(guo)(guo)际接轨,参(can)与(yu)ICH指(zhi)导(dao)原(yuan)(yuan)则的国(guo)(guo)际协调。一(yi)是积极参(can)与(yu)ICH议(yi)(yi)题协调工(gong)(gong)作,自原(yuan)(yuan)国(guo)(guo)家(jia)食品药品监(jian)督管理总局(ju)(ju)2017年(nian)加入ICH以来,已向(xiang)36个ICH工(gong)(gong)作组(zu)派出了(le)69名(ming)专(zhuan)家(jia),2020年(nian)参(can)与(yu)ICH工(gong)(gong)作组(zu)电话会(hui)(hui)437场(chang)。二是进(jin)一(yi)步推(tui)进(jin)ICH三级(ji)指(zhi)导(dao)原(yuan)(yuan)则实(shi)施(shi)工(gong)(gong)作,国(guo)(guo)家(jia)药监(jian)局(ju)(ju)共(gong)发(fa)布了(le)3个ICH指(zhi)导(dao)原(yuan)(yuan)则适用及推(tui)荐(jian)适用公告。三是组(zu)织开展(zhan)ICH指(zhi)导(dao)原(yuan)(yuan)则培(pei)训(xun)工(gong)(gong)作,药审(shen)中(zhong)(zhong)心开展(zhan)ICH指(zhi)导(dao)原(yuan)(yuan)则线上培(pei)训(xun)共(gong)15场(chang),主(zhu)要围绕(rao)29个ICH指(zhi)导(dao)原(yuan)(yuan)则的技术要点、实(shi)施(shi)现状、实(shi)施(shi)过程(cheng)中(zhong)(zhong)可能存在的问题等(deng)内(nei)容进(jin)行宣贯。培(pei)训(xun)对象主(zhu)要包括国(guo)(guo)家(jia)药监(jian)局(ju)(ju)相关司(si)局(ju)(ju)、各直属单位(wei)、各省级(ji)药监(jian)局(ju)(ju)和省级(ji)药检机构的相关工(gong)(gong)作人(ren)员,共(gong)计(ji)2723人(ren)观看培(pei)训(xun)直播,4244人(ren)观看直播回放。四(si)是召(zhao)开ICH指(zhi)导(dao)原(yuan)(yuan)则和协调议(yi)(yi)题研(yan)讨会(hui)(hui),为广泛听取行业(ye)及学界专(zhuan)家(jia)意见(jian),2020年(nian)药审(shen)中(zhong)(zhong)心共(gong)召(zhao)开ICH国(guo)(guo)内(nei)专(zhuan)家(jia)研(yan)讨会(hui)(hui)15场(chang),共(gong)计(ji)312人(ren)参(can)会(hui)(hui)。

(七)加(jia)强审评队伍建设(she)和管理

加强审评(ping)(ping)队(dui)伍建设,畅通审评(ping)(ping)员(yuan)职(zhi)业发展(zhan)(zhan)通道,开(kai)展(zhan)(zhan)主审审评(ping)(ping)员(yuan)认定工作;完善聘期(qi)考核评(ping)(ping)价体系,加强员(yuan)工聘期(qi)考核工作;开(kai)展(zhan)(zhan)补充性招(zhao)聘,引进临床(chuang)、统计等紧缺专业人才(cai);加强员(yuan)工培训(xun)(xun),组织开(kai)展(zhan)(zhan)《药品(pin)注册管理办法》及配(pei)套文件系列讲座、实训(xun)(xun)、英语口语等培训(xun)(xun)。

  九、加(jia)强服(fu)务指导、改进工(gong)作效率和(he)作风

2020年,药审中心驰(chi)而不息强化作风建设,积极服(fu)务药品高质量发展(zhan)新要求。

一是紧密围绕新(xin)(xin)(xin)冠(guan)(guan)肺炎疫(yi)(yi)情(qing)防(fang)控(kong)大(da)(da)局(ju),超常规(gui)创新(xin)(xin)(xin)开展应急(ji)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi),加强(qiang)审(shen)(shen)评(ping)(ping)服务保(bao)障,全(quan)力(li)做好(hao)新(xin)(xin)(xin)冠(guan)(guan)病(bing)毒(du)疫(yi)(yi)苗(miao)审(shen)(shen)评(ping)(ping)过程中(zhong)(zhong)的(de)(de)(de)(de)(de)各项工作。面对新(xin)(xin)(xin)冠(guan)(guan)肺炎疫(yi)(yi)情(qing)对新(xin)(xin)(xin)冠(guan)(guan)病(bing)毒(du)疫(yi)(yi)苗(miao)药(yao)(yao)物的(de)(de)(de)(de)(de)急(ji)迫需求(qiu),药(yao)(yao)审(shen)(shen)中(zhong)(zhong)心(xin)坚(jian)持(chi)尊重科学规(gui)律,建(jian)立早(zao)期介入,持(chi)续跟踪,主动(dong)服务、研审(shen)(shen)联动(dong)的(de)(de)(de)(de)(de)工作机(ji)制,始终保(bao)持(chi)24小时(shi)与(yu)企(qi)(qi)业畅通(tong)沟(gou)通(tong)的(de)(de)(de)(de)(de)状态,无论多晚(wan),即使是凌晨3-4点钟,都会第(di)一时(shi)间反(fan)馈研发(fa)(fa)企(qi)(qi)业诉求(qiu),在推动(dong)境(jing)外(wai)临床(chuang)试验上(shang)强(qiang)化担(dan)当,在创新(xin)(xin)(xin)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)中(zhong)(zhong)挖潜增效,成功高效推动(dong)国(guo)药(yao)(yao)集团新(xin)(xin)(xin)冠(guan)(guan)病(bing)毒(du)疫(yi)(yi)苗(miao)附条件批(pi)准(zhun)上(shang)市和(he)(he)5个疫(yi)(yi)苗(miao)品种(zhong)进(jin)入Ⅲ期临床(chuang)试验,确(que)保(bao)中(zhong)(zhong)国(guo)新(xin)(xin)(xin)冠(guan)(guan)病(bing)毒(du)疫(yi)(yi)苗(miao)走在世界前(qian)列,及时(shi)有力(li)支撑了(le)疫(yi)(yi)情(qing)防(fang)控(kong)大(da)(da)局(ju)。同时(shi)贯彻落实习近平总书记坚(jian)持(chi)中(zhong)(zhong)西医结合、中(zhong)(zhong)西药(yao)(yao)并用的(de)(de)(de)(de)(de)重要(yao)指示(shi)精(jing)神,主动(dong)对接临床(chuang)救治中(zhong)(zhong)应用的(de)(de)(de)(de)(de)“三药(yao)(yao)三方”生产企(qi)(qi)业和(he)(he)研发(fa)(fa)单位,积极做好(hao)有效中(zhong)(zhong)药(yao)(yao)方剂(ji)转化产品注册和(he)(he)临床(chuang)试验申请技术指导(dao),确(que)保(bao)中(zhong)(zhong)药(yao)(yao)第(di)一时(shi)间用于(yu)新(xin)(xin)(xin)冠(guan)(guan)肺炎患者救治。这(zhei)些成果不(bu)仅确(que)保(bao)了(le)防(fang)疫(yi)(yi)的(de)(de)(de)(de)(de)应急(ji)所需,还为常态化疫(yi)(yi)情(qing)防(fang)控(kong)准(zhun)备了(le)重要(yao)的(de)(de)(de)(de)(de)战略资(zi)源,不(bu)仅提振了(le)国(guo)人(ren)战胜疫(yi)(yi)情(qing)的(de)(de)(de)(de)(de)信心(xin),还为全(quan)球疫(yi)(yi)情(qing)防(fang)控(kong)贡献了(le)中(zhong)(zhong)国(guo)力(li)量。

二是(shi)强化服(fu)(fu)务(wu)申请(qing)(qing)人(ren)沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流。在(zai)新(xin)冠肺炎(yan)疫情(qing)(qing)防(fang)控常态化的(de)情(qing)(qing)况下(xia),全面落实新(xin)冠肺炎(yan)疫情(qing)(qing)联防(fang)联控措施(shi),最(zui)大限度减少人(ren)员(yuan)流动(dong)聚集,阻断(duan)疫情(qing)(qing)传播扩散渠(qu)(qu)道,切实保障申请(qing)(qing)人(ren)的(de)生命(ming)安全和身体健康,暂停(ting)现场咨(zi)(zi)询业(ye)务(wu)的(de)同时开通(tong)(tong)(tong)了电(dian)话(hua)咨(zi)(zi)询业(ye)务(wu)。增(zeng)设立了8个联系邮箱,申请(qing)(qing)人(ren)可以(yi)邮件咨(zi)(zi)询问题并提供(gong)在(zai)审品(pin)种受(shou)理(li)号等信息,项(xiang)目管(guan)理(li)人(ren)员(yuan)将(jiang)在(zai)3个工作日内(nei)与(yu)该受(shou)理(li)号相关(guan)的(de)申请(qing)(qing)人(ren)进行联系。通(tong)(tong)(tong)过(guo)不(bu)断(duan)丰(feng)富和拓展沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流的(de)渠(qu)(qu)道和方式,服(fu)(fu)务(wu)和便利申请(qing)(qing)人(ren);为鼓励创新(xin),更好地(di)体现沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流的(de)服(fu)(fu)务(wu)属性,结(jie)合《药(yao)品(pin)注册(ce)(ce)管(guan)理(li)办(ban)(ban)法(fa)(fa)》,从药(yao)物研制规律(lv)和注册(ce)(ce)要求(qiu)(qiu)出发(fa),秉持为药(yao)品(pin)注册(ce)(ce)申请(qing)(qing)人(ren)服(fu)(fu)务(wu)的(de)原则(ze)(ze),修订后(hou)发(fa)布(bu)了《药(yao)物研发(fa)与(yu)技术(shu)审评沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流管(guan)理(li)办(ban)(ban)法(fa)(fa)》。在(zai)保证受(shou)试(shi)者安全性的(de)基础上(shang),将(jiang)Ⅱ类会议划(hua)分为依法(fa)(fa)应沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流、原则(ze)(ze)上(shang)应当沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流、可以(yi)沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流三类情(qing)(qing)形(xing)(xing),并明确和细化了三类沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流的(de)情(qing)(qing)形(xing)(xing)和要求(qiu)(qiu);为提高沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流申请(qing)(qing)办(ban)(ban)理(li)的(de)可预见性和效率,药(yao)审中心通(tong)(tong)(tong)过(guo)持续优化沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流管(guan)理(li),细化环节时限控制,确保了申请(qing)(qing)人(ren)能够尽快享受(shou)到优质的(de)沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流服(fu)(fu)务(wu),努力满足申请(qing)(qing)人(ren)逐(zhu)年增(zeng)加的(de)沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流需求(qiu)(qiu),将(jiang)2020年沟(gou)(gou)通(tong)(tong)(tong)交(jiao)(jiao)(jiao)流申请(qing)(qing)办(ban)(ban)理(li)量提升至2019年办(ban)(ban)理(li)量的(de)1.31倍,这也是(shi)2016年办(ban)(ban)理(li)量的(de)11.35倍。

三是持续(xu)(xu)改善内部工作(zuo)作(zuo)风,提高(gao)(gao)(gao)工作(zuo)效率。这一(yi)年(nian)药审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)中(zhong)心继续(xu)(xu)深(shen)(shen)化审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批制(zhi)度改革,持续(xu)(xu)优化审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)流程,严(yan)格时限(xian)管理,实(shi)施审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)任务分析会制(zhi)度,加强项目督导,鼓励药品(pin)创新(xin),推(tui)动仿制(zhi)药高(gao)(gao)(gao)质量发展,审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)质量和(he)(he)效率有了极(ji)大(da)地提升,2020年(nian)全年(nian)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)结任务整体按时完成(cheng)率创历史新(xin)高(gao)(gao)(gao)。药品(pin)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批的(de)(de)可预期(qi)性进一(yi)步提高(gao)(gao)(gao),顺利(li)完成(cheng)《十(shi)三五(wu)药品(pin)安全规划》涉及药品(pin)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批改革目标。通(tong)过5年(nian)来深(shen)(shen)化药品(pin)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)批制(zhi)度改革的(de)(de)不懈(xie)努(nu)力,药审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)中(zhong)心实(shi)现了量变到质变的(de)(de)飞跃(yue),药品(pin)平均审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)时限(xian)大(da)幅(fu)压缩,审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)能(neng)力大(da)幅(fu)提升,一(yi)大(da)批创新(xin)药、临床急需(xu)药获批上(shang)市,累计通(tong)过和(he)(he)视同(tong)通(tong)过一(yi)致性评(ping)价审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)的(de)(de)品(pin)种(zhong)已达(da)445个,为十(shi)四五(wu)药品(pin)审(shen)(shen)(shen)(shen)(shen)(shen)(shen)(shen)评(ping)事(shi)业的(de)(de)发展奠定了坚实(shi)的(de)(de)基础。

药审(shen)中心将(jiang)深入梳理在提高审(shen)评(ping)效率、创新审(shen)评(ping)方式等(deng)方面的经(jing)验做法,使应急状态(tai)下的临时(shi)性措(cuo)施(shi),有序(xu)地(di)上升(sheng)为常(chang)态(tai)化审(shen)评(ping)工(gong)作长效机制,将(jiang)被动选择(ze)但被实践证明(ming)长期有效的方法转化为常(chang)态(tai)化条件(jian)下提高审(shen)评(ping)能力的主动选择(ze)。

十、加大药品(pin)审(shen)评(ping)审(shen)批信息公开力度

药(yao)(yao)(yao)审(shen)中心持续推(tui)进技(ji)术(shu)审(shen)评(ping)(ping)的(de)(de)信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)工作(zuo)(zuo),提高药(yao)(yao)(yao)品(pin)审(shen)评(ping)(ping)审(shen)批(pi)工作(zuo)(zuo)透(tou)明(ming)度(du)。一(yi)是完(wan)善(shan)信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)制(zhi)度(du),发布了(le)(le)(le)《药(yao)(yao)(yao)品(pin)审(shen)评(ping)(ping)审(shen)批(pi)信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)管理办法》,明(ming)确信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)的(de)(de)范围(wei)、种(zhong)类、时限等要求,为做好信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)工作(zuo)(zuo)提供了(le)(le)(le)制(zhi)度(du)依据。二(er)是大力推(tui)动新药(yao)(yao)(yao)技(ji)术(shu)审(shen)评(ping)(ping)报告的(de)(de)公(gong)(gong)开(kai)(kai)(kai),自开(kai)(kai)(kai)展工作(zuo)(zuo)以来已(yi)完(wan)成(cheng)公(gong)(gong)开(kai)(kai)(kai)新药(yao)(yao)(yao)技(ji)术(shu)审(shen)评(ping)(ping)报告316个(ge),指导(dao)行业研发,更(geng)好的(de)(de)服务药(yao)(yao)(yao)品(pin)注册申(shen)(shen)请(qing)人(ren)和公(gong)(gong)众。三是加大技(ji)术(shu)审(shen)评(ping)(ping)过(guo)程信(xin)(xin)(xin)息(xi)公(gong)(gong)开(kai)(kai)(kai)力度(du),通(tong)过(guo)药(yao)(yao)(yao)审(shen)中心网站向(xiang)申(shen)(shen)请(qing)人(ren)进一(yi)步(bu)公(gong)(gong)开(kai)(kai)(kai)了(le)(le)(le)审(shen)评(ping)(ping)排(pai)队信(xin)(xin)(xin)息(xi)、优先审(shen)评(ping)(ping)的(de)(de)状(zhuang)态信(xin)(xin)(xin)息(xi)、沟(gou)通(tong)交(jiao)流(liu)申(shen)(shen)请(qing)及(ji)办理信(xin)(xin)(xin)息(xi)等信(xin)(xin)(xin)息(xi),新增了(le)(le)(le)“突破(po)(po)性治疗公(gong)(gong)示”的(de)(de)栏(lan)目,公(gong)(gong)开(kai)(kai)(kai)了(le)(le)(le)“拟突破(po)(po)性治疗品(pin)种(zhong)、异议论证结果”等信(xin)(xin)(xin)息(xi)。方便(bian)申(shen)(shen)请(qing)人(ren)查询信(xin)(xin)(xin)息(xi),进一(yi)步(bu)拓(tuo)宽了(le)(le)(le)申(shen)(shen)请(qing)人(ren)的(de)(de)沟(gou)通(tong)渠道,及(ji)时回(hui)应社会(hui)关切,提高了(le)(le)(le)审(shen)评(ping)(ping)审(shen)批(pi)工作(zuo)(zuo)的(de)(de)透(tou)明(ming)度(du)。

 十一(yi)、2021年重点工作安(an)排

2020年(nian)(nian),药(yao)品审评(ping)(ping)工(gong)作(zuo)取得了一(yi)(yi)定(ding)进展,但仍(reng)存在着一(yi)(yi)些问题(ti):一(yi)(yi)是(shi)注册申(shen)请(qing)申(shen)报量,特别是(shi)创新(xin)药(yao)申(shen)报量连年(nian)(nian)递增,药(yao)审中心审评(ping)(ping)队伍规模结构与审评(ping)(ping)任务量配(pei)比失(shi)衡;二是(shi)高层(ceng)次(ci)及(ji)紧缺专业(ye)人才引进难、新(xin)进审评(ping)(ping)员急需长期(qi)专业(ye)培训等审评(ping)(ping)能(neng)力现代化短板问题(ti)突出(chu);三是(shi)新(xin)旧注册相关规定(ding)过渡期(qi)间,应及(ji)时研究问题(ti),给予相应的解(jie)决(jue)措施。2021年(nian)(nian)药(yao)审中心将紧密围绕国家药(yao)监局工(gong)作(zuo)部署(shu),重点开展以下工(gong)作(zuo):

(一)积(ji)极推动制度体系建设

完(wan)善新(xin)《药品(pin)注(zhu)册(ce)管(guan)理(li)办法(fa)》配(pei)套文件,做好新(xin)旧注(zhu)册(ce)相关(guan)规定过渡期相关(guan)工作,稳妥处理(li)历史问题;继续开(kai)展药品(pin)审评流程导向科(ke)(ke)学管(guan)理(li)体(ti)系(xi)(xi)建设工作,构建长效(xiao)运行机制,完(wan)善药品(pin)技术指导原(yuan)则体(ti)系(xi)(xi),规范(fan)中心制度体(ti)系(xi)(xi)建设,推(tui)动审评体(ti)系(xi)(xi)和审评能力现代(dai)化(hua);深入推(tui)进监(jian)管(guan)科(ke)(ke)学研究,深化(hua)与高校、科(ke)(ke)研院所合作,加(jia)快首批重点项目(mu)研究成果转化(hua)。

(二(er))毫不放松做好(hao)应急(ji)审评(ping)审批(pi)工作

始终(zhong)保持(chi)应急工作(zuo)状态,完善研审(shen)(shen)(shen)联动机制(zhi),坚持(chi)特事(shi)特办(ban),促进(jin)包括中医药(yao)、抗体(ti)(ti)药(yao)物(wu)等新冠(guan)肺炎治(zhi)疗药(yao)物(wu)的研发(fa);持(chi)续(xu)做好(hao)(hao)应急审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批核查检验(yan)协调工作(zuo);继续(xu)强化服(fu)务指导,持(chi)续(xu)跟进(jin)各条技术路线(xian)新冠(guan)病毒疫苗(miao)研发(fa)进(jin)展(zhan),依法依规严(yan)格审(shen)(shen)(shen)评(ping),继续(xu)做好(hao)(hao)新冠(guan)肺炎治(zhi)疗药(yao)物(wu)和新冠(guan)病毒疫苗(miao)审(shen)(shen)(shen)评(ping)工作(zuo);全(quan)面总结(jie)应急审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批工作(zuo)经验(yan),完善审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批制(zhi)度(du)体(ti)(ti)系,进(jin)一(yi)步激(ji)发(fa)药(yao)品创(chuang)新发(fa)展(zhan)活力。

(三)加快建(jian)立符合中医药特点的中药审评机制体系

构建中(zhong)(zhong)医(yi)药(yao)(yao)(yao)理论、中(zhong)(zhong)药(yao)(yao)(yao)人用经验和临床试验“三结合”的(de)审(shen)(shen)评(ping)(ping)证据体系,组建古代经典名(ming)方中(zhong)(zhong)药(yao)(yao)(yao)复方制剂专家(jia)审(shen)(shen)评(ping)(ping)委员会,扎(zha)实推进中(zhong)(zhong)药(yao)(yao)(yao)审(shen)(shen)评(ping)(ping)审(shen)(shen)批改革(ge);参考“三方”审(shen)(shen)评(ping)(ping)审(shen)(shen)批经验,逐步(bu)探索适合古代经典名(ming)方的(de)中(zhong)(zhong)药(yao)(yao)(yao)复方制剂的(de)审(shen)(shen)评(ping)(ping)指(zhi)导(dao)原则(ze)和标准,完善符合中(zhong)(zhong)医(yi)药(yao)(yao)(yao)特点的(de)技术指(zhi)导(dao)原则(ze);加快确有(you)临床价值的(de)中(zhong)(zhong)药(yao)(yao)(yao)新药(yao)(yao)(yao)审(shen)(shen)批,发挥(hui)中(zhong)(zhong)医(yi)药(yao)(yao)(yao)在(zai)疾病(bing)防治中(zhong)(zhong)的(de)独特优势。

(四)持续深化审(shen)评审(shen)批制度改革

巩固按时限(xian)审评改革(ge)(ge)成果,完善项目管理工作机制(zhi);完善专家咨询委员(yuan)会制(zhi)度(du),解(jie)决争议重大(da)疑难(nan)问题,利用巡视整(zheng)改要(yao)(yao)求推(tui)动(dong)制(zhi)度(du)改革(ge)(ge),加(jia)大(da)审评审批信(xin)息公开(kai)力度(du),优化沟通交流制(zhi)度(du),提高审评服务水平(ping);细化上市药品(pin)变更管理技术要(yao)(yao)求,指(zhi)(zhi)导药品(pin)上市许可持有人开(kai)展上市后(hou)持续研(yan)究;进(jin)(jin)一步加(jia)强临床试验期间安全性评价及药物警戒体系建设;持续推(tui)进(jin)(jin)ICH指(zhi)(zhi)导原则在国(guo)内转化实施;加(jia)快审评数字化建设,推(tui)进(jin)(jin)eCTD系统(tong)使用。加(jia)快推(tui)进(jin)(jin)研(yan)发生产主体信(xin)息库建设。

(五)坚持鼓励药(yao)品研(yan)发创新

持(chi)(chi)续(xu)完(wan)善药(yao)品审评(ping)审批制度体(ti)系,坚持(chi)(chi)以(yi)安全有效为根本(ben)标(biao)准,优化(hua)(hua)审评(ping)资源配(pei)置(zhi),在创新药(yao)审评(ping)中探索实(shi)施(shi)“提前(qian)介入”“研(yan)审联动”“平(ping)行检验”“前(qian)置(zhi)检验”等方式;继(ji)续(xu)鼓励(li)新药(yao)好药(yao)研(yan)发创新,强化(hua)(hua)沟通(tong)交流(liu),优先配(pei)置(zhi)资源,进一步(bu)细化(hua)(hua)和实(shi)施(shi)突破性(xing)治(zhi)疗药(yao)物、附条件批准、优先审评(ping)、特别审批等加快审评(ping)程序,加快临床急需境外新药(yao)、罕见病(bing)用(yong)药(yao)、儿童用(yong)药(yao)、重(zhong)大传染病(bing)用(yong)药(yao)等上市速度。

(六)推动仿制(zhi)药高质量发展

持续完善仿制(zhi)(zhi)药参比制(zhi)(zhi)剂遴选,坚(jian)持标准不降低的(de)原则,稳妥有序推进(jin)仿制(zhi)(zhi)药质(zhi)量和疗(liao)效(xiao)一(yi)致性评(ping)价;进(jin)一(yi)步完善仿制(zhi)(zhi)药相关技术(shu)指导(dao)原则和标准体系建设;以建立审评(ping)要点体系为基础(chu),推动仿制(zhi)(zhi)药审评(ping)科学规范、标准,提高仿制(zhi)(zhi)药审评(ping)质(zhi)量和效(xiao)率(lv)。

(七)优化人才队伍建设

按照国家(jia)药监(jian)局统(tong)一部署,全力指导(dao)和推进长三(san)角(jiao)、大(da)湾区两(liang)个分(fen)中心建(jian)(jian)设(she)(she)(she);以专(zhuan)业培训为(wei)抓手,进一步(bu)加(jia)强药品审评队(dui)(dui)伍(wu)能力建(jian)(jian)设(she)(she)(she);配合药品审评业务,积极开展人员(yuan)招(zhao)聘(pin)工作(zuo),加(jia)强队(dui)(dui)伍(wu)建(jian)(jian)设(she)(she)(she);进一步(bu)加(jia)强专(zhuan)业技(ji)术(shu)队(dui)(dui)伍(wu)建(jian)(jian)设(she)(she)(she),完善专(zhuan)业技(ji)术(shu)队(dui)(dui)伍(wu)晋升等制(zhi)度;进一步(bu)严(yan)格人员(yuan)招(zhao)聘(pin)条件,规范(fan)人员(yuan)离职,严(yan)格队(dui)(dui)伍(wu)管理。

 十二、结语

大鹏(peng)一日同(tong)风起(qi),扶摇(yao)直上(shang)九(jiu)(jiu)万(wan)里。2021年是实(shi)施(shi)“十(shi)(shi)四(si)五(wu)”规(gui)划的(de)(de)开(kai)局(ju)之年,药审(shen)(shen)中(zhong)(zhong)心(xin)将在国(guo)家药监局(ju)的(de)(de)坚(jian)(jian)强领导下,坚(jian)(jian)持以(yi)习近(jin)平新时代中(zhong)(zhong)国(guo)特色社会(hui)主义思(si)想(xiang)(xiang)为指导,全(quan)(quan)面贯彻党的(de)(de)十(shi)(shi)九(jiu)(jiu)大和(he)十(shi)(shi)九(jiu)(jiu)届二中(zhong)(zhong)、三中(zhong)(zhong)、四(si)中(zhong)(zhong)、五(wu)中(zhong)(zhong)全(quan)(quan)会(hui)精(jing)神,坚(jian)(jian)持以(yi)人(ren)民为中(zhong)(zhong)心(xin)的(de)(de)发展(zhan)思(si)想(xiang)(xiang),按照(zhao)立(li)足新发展(zhan)阶段,贯彻新发展(zhan)理念,构建新发展(zhan)格局(ju)的(de)(de)要求,以(yi)习近(jin)平总(zong)书记“四(si)个(ge)最严”要求为根(gen)(gen)本(ben)遵循,以(yi)鼓励创新推动药品高质量发展(zhan)为主题,以(yi)深化(hua)药品审(shen)(shen)评(ping)(ping)审(shen)(shen)批制度改革为主线,以(yi)满足人(ren)民日益(yi)增长的(de)(de)美好(hao)生活需要为根(gen)(gen)本(ben)目的(de)(de),以(yi)建设国(guo)际化(hua)现(xian)代化(hua)科学化(hua)药品审(shen)(shen)评(ping)(ping)机构为根(gen)(gen)本(ben)动力(li),坚(jian)(jian)持为国(guo)为民履职尽责(ze),切实(shi)保障药品安全(quan)(quan)有效(xiao)可及,保护(hu)和(he)促(cu)进公众健(jian)康,努力(li)实(shi)现(xian)“十(shi)(shi)四(si)五(wu)”时期发展(zhan)开(kai)好(hao)局(ju)、起(qi)好(hao)步,以(yi)优异成(cheng)绩(ji)迎(ying)接中(zhong)(zhong)国(guo)共产党成(cheng)立(li)100周年。

 

 

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来源:国家药品监督管理局网站,具体详见:http://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20210621142436183.html