2020年度药品审评报告

时间:2020-06-22

2020年是极不平(ping)凡(fan)的一年,面对突如其(qi)来的新(xin)冠(guan)肺炎疫(yi)(yi)情(qing)(qing),国家(jia)药(yao)(yao)品监(jian)督(du)管(guan)(guan)理局(ju)(ju)药(yao)(yao)品审(shen)(shen)评(ping)(ping)中(zhong)心(以下(xia)简(jian)称药(yao)(yao)审(shen)(shen)中(zhong)心)在国家(jia)药(yao)(yao)品监(jian)督(du)管(guan)(guan)理局(ju)(ju)(以下(xia)简(jian)称国家(jia)药(yao)(yao)监(jian)局(ju)(ju))的坚(jian)强领(ling)导下(xia),认(ren)真(zhen)学(xue)习贯(guan)彻习近平(ping)总书记重要讲话和(he)(he)重要指示批示精神,闻(wen)令而动、尽锐出战,坚(jian)持人(ren)(ren)民(min)至上(shang)、生命至上(shang),超常规建立(li)“早期介入、持续跟(gen)踪、主(zhu)动服务(wu)(wu)、研(yan)审(shen)(shen)联动”全天候应急审(shen)(shen)评(ping)(ping)审(shen)(shen)批工(gong)作机制,加速推动新(xin)冠(guan)病(bing)毒疫(yi)(yi)苗和(he)(he)新(xin)冠(guan)肺炎治疗药(yao)(yao)物研(yan)发(fa)(fa)上(shang)市,充分发(fa)(fa)挥(hui)技(ji)术审(shen)(shen)评(ping)(ping)对疫(yi)(yi)情(qing)(qing)防(fang)控的科技(ji)支(zhi)撑作用;主(zhu)动服务(wu)(wu)于(yu)药(yao)(yao)监(jian)系统工(gong)作大局(ju)(ju),紧(jin)紧(jin)围绕(rao)落(luo)实(shi)党中(zhong)央国务(wu)(wu)院审(shen)(shen)评(ping)(ping)审(shen)(shen)批制度改革、贯(guan)彻《药(yao)(yao)品管(guan)(guan)理法》《疫(yi)(yi)苗管(guan)(guan)理法》《药(yao)(yao)品注册管(guan)(guan)理办法》、推动审(shen)(shen)评(ping)(ping)体系和(he)(he)审(shen)(shen)评(ping)(ping)能力现代化,统筹推进(jin)疫(yi)(yi)情(qing)(qing)防(fang)控和(he)(he)依法依规科学(xue)审(shen)(shen)评(ping)(ping)工(gong)作,不断(duan)提高(gao)审(shen)(shen)评(ping)(ping)质(zhi)量(liang)和(he)(he)效率,不断(duan)加快(kuai)新(xin)药(yao)(yao)研(yan)发(fa)(fa)上(shang)市步(bu)伐(fa),为疫(yi)(yi)情(qing)(qing)防(fang)控和(he)(he)满足(zu)临床急需(xu)提供有效药(yao)(yao)物保(bao)障、为医药(yao)(yao)产业高(gao)质(zhi)量(liang)发(fa)(fa)展(zhan)提供有力促(cu)进(jin)作用,保(bao)障了人(ren)(ren)民(min)群众用药(yao)(yao)安全有效可及,药(yao)(yao)品审(shen)(shen)评(ping)(ping)事业得到新(xin)发(fa)(fa)展(zhan)、迈上(shang)新(xin)台阶、开创(chuang)新(xin)局(ju)(ju)面。 

一、药品(pin)注册申请审评审批情况

(一)总体完成情况

1.全年审(shen)评审(shen)批完成情(qing)况

2020年(nian),根据《药(yao)(yao)品(pin)(pin)注(zhu)册(ce)(ce)(ce)管(guan)(guan)理(li)办法》(国(guo)家(jia)市场监(jian)督管(guan)(guan)理(li)总局令第27号(hao))、《国(guo)家(jia)药(yao)(yao)监(jian)局关(guan)于实施<药(yao)(yao)品(pin)(pin)注(zhu)册(ce)(ce)(ce)管(guan)(guan)理(li)办法>有关(guan)事(shi)宜的(de)公告》(2020年(nian)第46号(hao),以(yi)下简称46号(hao)公告)及(ji)《药(yao)(yao)品(pin)(pin)注(zhu)册(ce)(ce)(ce)管(guan)(guan)理(li)办法》相关(guan)配套文件(jian),药(yao)(yao)审(shen)(shen)中(zhong)(zhong)心完成(cheng)中(zhong)(zhong)药(yao)(yao)(包括(kuo)民族药(yao)(yao),下同(tong)(tong))、化学药(yao)(yao)、生物制品(pin)(pin)各类注(zhu)册(ce)(ce)(ce)申(shen)(shen)请(qing)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)共11582件(jian)(含器械组合产品(pin)(pin)4件(jian),以(yi)受理(li)号(hao)计,下同(tong)(tong)),较2019年(nian)增长32.67%(如无说明(ming),以(yi)注(zhu)册(ce)(ce)(ce)申(shen)(shen)请(qing)件(jian)数计,下同(tong)(tong))。其中(zhong)(zhong),完成(cheng)需技术(shu)审(shen)(shen)评(ping)(ping)的(de)注(zhu)册(ce)(ce)(ce)申(shen)(shen)请(qing)8606件(jian)(含5674件(jian)需药(yao)(yao)审(shen)(shen)中(zhong)(zhong)心技术(shu)审(shen)(shen)评(ping)(ping)和行政审(shen)(shen)批(pi)注(zhu)册(ce)(ce)(ce)申(shen)(shen)请(qing)),较2019年(nian)增长26.24%;完成(cheng)直接行政审(shen)(shen)批(pi)(无需技术(shu)审(shen)(shen)评(ping)(ping),下同(tong)(tong))的(de)注(zhu)册(ce)(ce)(ce)申(shen)(shen)请(qing)2972件(jian)。2020年(nian)底(di)正在审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)和等待审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)的(de)注(zhu)册(ce)(ce)(ce)申(shen)(shen)请(qing)已由2015年(nian)9月高峰时的(de)近22000件(jian)降至4882件(jian)(不含完成(cheng)技术(shu)审(shen)(shen)评(ping)(ping)因申(shen)(shen)报(bao)资料缺陷(xian)等待申(shen)(shen)请(qing)人(ren)回复(fu)补充资料的(de)注(zhu)册(ce)(ce)(ce)申(shen)(shen)请(qing))。

完成8606件需技术审评的药(yao)品(pin)注(zhu)册(ce)(ce)(ce)申(shen)请(qing)中,化学(xue)药(yao)注(zhu)册(ce)(ce)(ce)申(shen)请(qing)为(wei)6778件,较2019年(nian)增长25.22%;中药(yao)注(zhu)册(ce)(ce)(ce)申(shen)请(qing)418件,较2019年(nian)增长39.33%;生物(wu)制(zhi)品(pin)注(zhu)册(ce)(ce)(ce)申(shen)请(qing)1410件,较2019年(nian)增长27.72%;化学(xue)药(yao)注(zhu)册(ce)(ce)(ce)申(shen)请(qing)约(yue)占全部(bu)技术审评完成量的78.76%。2016-2020年(nian)中药(yao)、生物(wu)制(zhi)品(pin)、化学(xue)药(yao)注(zhu)册(ce)(ce)(ce)申(shen)请(qing)审评审批完成情况详见图1。

 

 

  药(yao)审中(zhong)心(xin)完(wan)(wan)成(cheng)(cheng)需技(ji)术审评(ping)(ping)(ping)(ping)的8606件(jian)(jian)注册申(shen)(shen)请(qing)(qing)中(zhong),完(wan)(wan)成(cheng)(cheng)新药(yao)临(lin)床(chuang)试(shi)验(IND)申(shen)(shen)请(qing)(qing)审评(ping)(ping)(ping)(ping)1561件(jian)(jian),较(jiao)2019年(nian)(nian)增长55.94%;完(wan)(wan)成(cheng)(cheng)新药(yao)上市申(shen)(shen)请(qing)(qing)(NDA)审评(ping)(ping)(ping)(ping)289件(jian)(jian),完(wan)(wan)成(cheng)(cheng)仿制药(yao)上市申(shen)(shen)请(qing)(qing)(ANDA)审评(ping)(ping)(ping)(ping)1700件(jian)(jian);完(wan)(wan)成(cheng)(cheng)仿制药(yao)质(zhi)量(liang)和疗效一致(zhi)性评(ping)(ping)(ping)(ping)价(以下(xia)简(jian)称(cheng)一致(zhi)性评(ping)(ping)(ping)(ping)价)申(shen)(shen)请(qing)(qing)(以补充(chong)申(shen)(shen)请(qing)(qing)途径申(shen)(shen)报)1136件(jian)(jian),较(jiao)2019年(nian)(nian)增长103.22%;完(wan)(wan)成(cheng)(cheng)补充(chong)申(shen)(shen)请(qing)(qing)技(ji)术审评(ping)(ping)(ping)(ping)3250件(jian)(jian),较(jiao)2019年(nian)(nian)增长24.19%。2016-2020年(nian)(nian)各类注册申(shen)(shen)请(qing)(qing)审评(ping)(ping)(ping)(ping)完(wan)(wan)成(cheng)(cheng)情况详见图2。

 

3.审评通过情况

2020年(nian),药审(shen)中心审(shen)评通(tong)过(guo)批准(zhun)(zhun)IND申请1435件(jian),较2019年(nian)增长54.97%;审(shen)评通(tong)过(guo)NDA 208件(jian),较2019年(nian)增长26.83%;审(shen)评通(tong)过(guo)ANDA 918件(jian);审(shen)评通(tong)过(guo)批准(zhun)(zhun)一致性(xing)评价(jia)申请577件(jian),较2019年(nian)增长121.92%。

药审中心审评通过创新药NDA 20个(ge)品种(zhong),审评通过境外生产原(yuan)研药品NDA 72个(ge)品种(zhong)(含新增(zeng)适应症品种(zhong)),具(ju)体品种(zhong)详见(jian)附件1、2。

4.审结(jie)注册申请任务按(an)时限(xian)完成情(qing)况

2020年,药审中(zhong)心持续优化审评(ping)(ping)流程,严(yan)格审评(ping)(ping)时(shi)(shi)限(xian)(xian)管理,加(jia)强项目(mu)督导,加(jia)快审评(ping)(ping)速度(du),整体(ti)(ti)审评(ping)(ping)任(ren)(ren)务和重点序(xu)列(lie)审评(ping)(ping)任(ren)(ren)务按(an)(an)时(shi)(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)均(jun)(jun)取得显著(zhu)提升。全年审结(jie)(jie)注册(ce)申请(qing)(qing)任(ren)(ren)务整体(ti)(ti)按(an)(an)时(shi)(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)为94.48%,其(qi)中(zhong)临床急需(xu)境外已上市新药注册(ce)申请(qing)(qing)审结(jie)(jie)任(ren)(ren)务整体(ti)(ti)按(an)(an)时(shi)(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)为100%,按(an)(an)默示(shi)许(xu)可(ke)受(shou)理注册(ce)申请(qing)(qing)的审结(jie)(jie)任(ren)(ren)务整体(ti)(ti)按(an)(an)时(shi)(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)为99.87%,直接行政审批(pi)的注册(ce)申请(qing)(qing)100%在法定的20个工作(zuo)日(ri)(ri)内完(wan)(wan)成(cheng),且审批(pi)平均(jun)(jun)用时(shi)(shi)11.8个工作(zuo)日(ri)(ri)。各类注册(ce)申请(qing)(qing)任(ren)(ren)务按(an)(an)时(shi)(shi)限(xian)(xian)完(wan)(wan)成(cheng)情况详见表1。

 

  2020年(nian)的NDA年(nian)度整体按(an)时(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)(lv)已(yi)经有了很(hen)大的提升,例如(ru):NDA按(an)时(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)(lv)在2020年(nian)12月(yue)突破(po)80%,提升至87.5%;ANDA按(an)时(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)(lv)在2020年(nian)12月(yue)突破(po)90%,达(da)到93.85%;纳入(ru)优先审(shen)评(ping)程(cheng)序的注册申请按(an)时(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)(lv)在2020年(nian)10-12月(yue)的月(yue)度按(an)时(shi)限(xian)(xian)完(wan)(wan)成(cheng)率(lv)(lv)连续达(da)到90%以上,取(qu)得历史(shi)性突破(po)。

(二)中药注册申(shen)请审(shen)评完成情况

1.总体情(qing)况(kuang)

2020年,药审中(zhong)(zhong)心完(wan)(wan)成(cheng)(cheng)审评(ping)的(de)中(zhong)(zhong)药注册申(shen)请418件。其中(zhong)(zhong),完(wan)(wan)成(cheng)(cheng)IND申(shen)请37件,完(wan)(wan)成(cheng)(cheng)NDA 8件,完(wan)(wan)成(cheng)(cheng)ANDA 3件。2020年中(zhong)(zhong)药各类注册申(shen)请的(de)审评(ping)完(wan)(wan)成(cheng)(cheng)情况详(xiang)见(jian)图3。

 

2.审评通过情况

药(yao)(yao)审(shen)中心审(shen)评(ping)(ping)(ping)通(tong)过批准中药(yao)(yao)IND申请28件,审(shen)评(ping)(ping)(ping)通(tong)过中药(yao)(yao)NDA 4件(连花清咳(ke)片(pian)、筋骨止痛凝胶、桑(sang)枝总生物(wu)碱片(pian)及桑(sang)枝总生物(wu)碱)。2020年中药(yao)(yao)各(ge)类注册申请审(shen)评(ping)(ping)(ping)完成的具体情况详(xiang)见(jian)表2,2016-2020年审(shen)评(ping)(ping)(ping)通(tong)过批准中药(yao)(yao)IND申请和审(shen)评(ping)(ping)(ping)通(tong)过中药(yao)(yao)NDA情况详(xiang)见(jian)图4。

 

 

  药审(shen)(shen)中(zhong)(zhong)心审(shen)(shen)评通过批准(zhun)的中(zhong)(zhong)药IND申(shen)请28件(jian)(jian),涉及(ji)10个(ge)适(shi)应症(zheng)领域。其中(zhong)(zhong),呼吸7件(jian)(jian)、骨(gu)科4件(jian)(jian)、消化4件(jian)(jian),共占(zhan)53.57%,2020年(nian)审(shen)(shen)评通过批准(zhun)的中(zhong)(zhong)药IND申(shen)请适(shi)应症(zheng)分布详见图5。

 

(三)化学药注册申请审(shen)评完成情况(kuang)

1.总体(ti)情况

2020年(nian)(nian),药(yao)审(shen)(shen)中(zhong)心完(wan)(wan)(wan)成审(shen)(shen)评的(de)化(hua)(hua)学药(yao)注册申(shen)(shen)请(qing)(qing)(qing)6778件(jian)(jian)。其中(zhong),完(wan)(wan)(wan)成化(hua)(hua)学药(yao)临床(chuang)申(shen)(shen)请(qing)(qing)(qing)(IND申(shen)(shen)请(qing)(qing)(qing)和验(yan)证(zheng)性(xing)临床(chuang))共1086件(jian)(jian),较(jiao)2019年(nian)(nian)增长45.58%;完(wan)(wan)(wan)成化(hua)(hua)学药(yao)NDA 163件(jian)(jian);完(wan)(wan)(wan)成化(hua)(hua)学药(yao)ANDA 1697件(jian)(jian);完(wan)(wan)(wan)成一致性(xing)评价申(shen)(shen)请(qing)(qing)(qing)1136件(jian)(jian),较(jiao)2019年(nian)(nian)增长103.22%;完(wan)(wan)(wan)成化(hua)(hua)学药(yao)补(bu)充(chong)申(shen)(shen)请(qing)(qing)(qing)2248件(jian)(jian),较(jiao)2019年(nian)(nian)增长23.72%。2020年(nian)(nian)化(hua)(hua)学药(yao)各类注册申(shen)(shen)请(qing)(qing)(qing)的(de)审(shen)(shen)评完(wan)(wan)(wan)成情况详见(jian)图(tu)6。

 

2.审评通过情况

药(yao)(yao)审(shen)中(zhong)心完成审(shen)评(ping)(ping)的(de)化学药(yao)(yao)注册申(shen)请中(zhong),审(shen)评(ping)(ping)通(tong)过批准IND申(shen)请907件,较(jiao)2019年(nian)增长51.42%;审(shen)评(ping)(ping)通(tong)过NDA 115件,较(jiao)2019年(nian)增长30.68%;审(shen)评(ping)(ping)通(tong)过ANDA 918件,较(jiao)2019年(nian)增长15.33%。2020年(nian)化学药(yao)(yao)各(ge)类注册申(shen)请审(shen)评(ping)(ping)完成的(de)具体(ti)情况(kuang)详见(jian)表3。

 

药审中心完成审评(ping)(ping)的化学(xue)药IND申(shen)请(qing)960件,审评(ping)(ping)通(tong)过批准IND申(shen)请(qing)907件。其中,1类创新化学(xue)药IND申(shen)请(qing)694件(298个品种),较2019年增长40.77%,品种数较2019年增长57.67%。2016-2020年审评(ping)(ping)通(tong)过批准化学(xue)药IND申(shen)请(qing)、1类创新化学(xue)药IND申(shen)请(qing)情况(kuang)详见图7。

 

药(yao)(yao)(yao)(yao)审(shen)中心审(shen)评通过(guo)批(pi)准(zhun)IND申(shen)请的694件1类(lei)创(chuang)新(xin)化(hua)学药(yao)(yao)(yao)(yao)中,抗(kang)肿瘤药(yao)(yao)(yao)(yao)物(wu)、抗(kang)感染(ran)药(yao)(yao)(yao)(yao)物(wu)、循环系统疾病(bing)药(yao)(yao)(yao)(yao)物(wu)、内分泌系统药(yao)(yao)(yao)(yao)物(wu)、消化(hua)系统疾病(bing)药(yao)(yao)(yao)(yao)物(wu)和风湿性疾病(bing)及免疫药(yao)(yao)(yao)(yao)物(wu)较(jiao)多,占全(quan)部(bu)创(chuang)新(xin)药(yao)(yao)(yao)(yao)临床试(shi)验批(pi)准(zhun)数量的80.69%。2020年审(shen)评通过(guo)批(pi)准(zhun)的1类(lei)创(chuang)新(xin)化(hua)学药(yao)(yao)(yao)(yao)IND申(shen)请适应症分布详(xiang)见图8。

 

药(yao)审(shen)中(zhong)心完成审(shen)评(ping)的化(hua)(hua)学药(yao)NDA共163件。其中(zhong),审(shen)评(ping)通(tong)过化(hua)(hua)药(yao)NDA 115件,审(shen)评(ping)通(tong)过1类创新化(hua)(hua)学药(yao)NDA 14个品种。2016-2020年审(shen)评(ping)通(tong)过化(hua)(hua)学药(yao)NDA情况详见图9。

 

  药审(shen)(shen)(shen)中(zhong)心(xin)完成审(shen)(shen)(shen)评(ping)(ping)(ping)的一致性(xing)评(ping)(ping)(ping)价(jia)(jia)申请共1136件(jian)(jian),审(shen)(shen)(shen)评(ping)(ping)(ping)通过577件(jian)(jian)。其中(zhong),审(shen)(shen)(shen)评(ping)(ping)(ping)通过批准(zhun)口(kou)服(fu)固(gu)体(ti)制剂一致性(xing)评(ping)(ping)(ping)价(jia)(jia)456件(jian)(jian),审(shen)(shen)(shen)评(ping)(ping)(ping)通过批准(zhun)注(zhu)射(she)剂一致性(xing)评(ping)(ping)(ping)价(jia)(jia)申请121件(jian)(jian),具(ju)体(ti)品种(zhong)详(xiang)见(jian)附件(jian)(jian)3。2018-2020年(nian)审(shen)(shen)(shen)评(ping)(ping)(ping)通过批准(zhun)的一致性(xing)评(ping)(ping)(ping)价(jia)(jia)申请情(qing)况详(xiang)见(jian)图10。

 

(四)生物制品注册申请(qing)审评完成情况

1.总体情况

2020年(nian),药审中心完成审评的生(sheng)(sheng)物(wu)制(zhi)品(pin)(pin)注册(ce)申(shen)请(qing)共1410件(jian)。其中,完成预防(fang)(fang)用(yong)(yong)生(sheng)(sheng)物(wu)制(zhi)品(pin)(pin)IND申(shen)请(qing)(预防(fang)(fang)用(yong)(yong)IND申(shen)请(qing))27件(jian),完成治疗用(yong)(yong)生(sheng)(sheng)物(wu)制(zhi)品(pin)(pin)IND申(shen)请(qing)(治疗用(yong)(yong)IND申(shen)请(qing))537件(jian),较2019年(nian)增长58.88%;完成预防(fang)(fang)用(yong)(yong)生(sheng)(sheng)物(wu)制(zhi)品(pin)(pin)NDA(预防(fang)(fang)用(yong)(yong)NDA)9件(jian),完成治疗用(yong)(yong)生(sheng)(sheng)物(wu)制(zhi)品(pin)(pin)NDA(治疗用(yong)(yong)NDA)108件(jian),完成体(ti)外(wai)诊断试剂NDA(体(ti)外(wai)诊断NDA)1件(jian)。2020年(nian)生(sheng)(sheng)物(wu)制(zhi)品(pin)(pin)各类注册(ce)申(shen)请(qing)的审评完成情况详(xiang)见图11。

 

2.审评通(tong)过情况(kuang)

药审(shen)中(zhong)(zhong)心审(shen)评(ping)通(tong)过(guo)批准生(sheng)物(wu)制(zhi)品IND申请(qing)500件(jian)(jian),较2019年(nian)增长60.26%。其中(zhong)(zhong),预防用(yong)IND申请(qing)19件(jian)(jian);治疗用(yong)IND申请(qing)481件(jian)(jian),较2019年(nian)增长63.61%。审(shen)评(ping)通(tong)过(guo)生(sheng)物(wu)制(zhi)品NDA 89件(jian)(jian),较2019年(nian)增长20.27%。其中(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2019年(nian)增长19.12%;体外(wai)诊(zhen)断NDA 1件(jian)(jian)。2020年(nian)生(sheng)物(wu)制(zhi)品各类注册申请(qing)审(shen)评(ping)完成的具体情况(kuang)详(xiang)见表4,2016-2020年(nian)审(shen)评(ping)通(tong)过(guo)批准生(sheng)物(wu)制(zhi)品IND申请(qing)和(he)审(shen)评(ping)通(tong)过(guo)NDA情况(kuang)详(xiang)见图(tu)12。

 

 

药审(shen)(shen)(shen)中(zhong)心审(shen)(shen)(shen)评(ping)(ping)通(tong)过批准生(sheng)物制(zhi)品IND申请(qing)500件(jian),2020年审(shen)(shen)(shen)评(ping)(ping)通(tong)过批准的生(sheng)物制(zhi)品IND申请(qing)适应(ying)(ying)症(zheng)分(fen)布(bu)详见图(tu)13。药审(shen)(shen)(shen)中(zhong)心审(shen)(shen)(shen)评(ping)(ping)通(tong)过生(sheng)物制(zhi)品NDA 89件(jian),2020年审(shen)(shen)(shen)评(ping)(ping)通(tong)过的生(sheng)物制(zhi)品NDA适应(ying)(ying)症(zheng)分(fen)布(bu)详见图(tu)14。

 

 

(五)行政审批注册申(shen)请完成(cheng)情(qing)况

1.总体情况

2020年(nian),药(yao)审(shen)(shen)中心完(wan)成中药(yao)、化学药(yao)、生(sheng)物制(zhi)品各类(lei)注册(ce)申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)行(xing)(xing)政审(shen)(shen)批(pi)共8646件,较2019年(nian)增长(zhang)(zhang)44.51%。其中,完(wan)成审(shen)(shen)评审(shen)(shen)批(pi)的注册(ce)申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)(临床试验申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)、一致性评价申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)、补充(chong)申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)、境外生(sheng)产药(yao)品再注册(ce)及(ji)复审(shen)(shen))5674件,较2019年(nian)增长(zhang)(zhang)39.24%;完(wan)成直(zhi)接行(xing)(xing)政审(shen)(shen)批(pi)的注册(ce)申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)(无需技术(shu)审(shen)(shen)评的补充(chong)申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)、临时进口申(shen)(shen)(shen)(shen)请(qing)(qing)(qing))2972件,较2019年(nian)增长(zhang)(zhang)55.77%。2020年(nian)中药(yao)、化学药(yao)、生(sheng)物制(zhi)品各类(lei)注册(ce)申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)行(xing)(xing)政审(shen)(shen)批(pi)完(wan)成情况见表(biao)5。2018-2020年(nian)行(xing)(xing)政审(shen)(shen)批(pi)注册(ce)申(shen)(shen)(shen)(shen)请(qing)(qing)(qing)完(wan)成情况详(xiang)见图15。

 

 

2.需审评审批的注册申请完(wan)成情况

药审(shen)中心完成的(de)需(xu)审(shen)评(ping)审(shen)批的(de)5674件注册(ce)申请中,临床试验申请1686件(含验证性临床),较(jiao)2019年增(zeng)长(zhang)(zhang)50.00%;一致(zhi)性评(ping)价申请623件,较(jiao)2019年增(zeng)长(zhang)(zhang)80.58%;补充申请2860件,较(jiao)2019年增(zeng)长(zhang)(zhang)34.46%;境外(wai)生产药品再注册(ce)478件、复审(shen)27件。

3.直接行(xing)政审(shen)批的注册申请完(wan)成情况

药审中(zhong)心(xin)完成直接(jie)行(xing)政(zheng)审批的2972件(jian)注(zhu)册申请(qing)中(zhong),按(an)注(zhu)册申请(qing)类型(xing)划分,补充申请(qing)2537件(jian)、临(lin)时进口申请(qing)435件(jian)。按(an)药品(pin)类型(xing)划分,中(zhong)药153件(jian)、化学药2411件(jian)、生物(wu)制品(pin)408件(jian)。

(六(liu))注册申请不批(pi)准(zhun)的(de)主要(yao)原因及存在的(de)问题

2020年,中药、化学药、生物制(zhi)品(pin)(pin)各类药品(pin)(pin)注(zhu)(zhu)册(ce)(ce)申请因申报资料无法证明药品(pin)(pin)安全性(xing)、有效性(xing)或者质(zhi)量(liang)可控性(xing),以及未能按期提交补充资料等(deng)情形,导致审评结(jie)论为建议不批(pi)准的(de)共367件。通过(guo)系统(tong)梳理上述注(zhu)(zhu)册(ce)(ce)申请不批(pi)准原因,从新(xin)药、仿制(zhi)药等(deng)不同注(zhu)(zhu)册(ce)(ce)分(fen)类角度分(fen)析药品(pin)(pin)注(zhu)(zhu)册(ce)(ce)申请在研发和申报过(guo)程中存在的(de)主(zhu)要问题包括(kuo):

1.新(xin)药申请

IND申请和(he)(he)研(yan)发(fa)中存在(zai)(zai)的(de)(de)问题主要有(you):正式(shi)申报(bao)前(qian)未开展沟通(tong)交流;开发(fa)立题依据(ju)不(bu)足,成(cheng)药(yao)性存在(zai)(zai)严(yan)重缺陷;申报(bao)资(zi)料不(bu)足以(yi)支持开展药(yao)物临(lin)(lin)床试验或者不(bu)能保障(zhang)临(lin)(lin)床受试者安全。具体表现包括:未沟通(tong)交流致(zhi)使申报(bao)后发(fa)现研(yan)究(jiu)信息严(yan)重缺项,无(wu)法在(zai)(zai)时限(xian)内完成(cheng)补(bu)充研(yan)究(jiu);已(yi)有(you)的(de)(de)研(yan)究(jiu)结(jie)果提示药(yao)效作(zuo)用(yong)(yong)弱,毒性大(da),临(lin)(lin)床获益和(he)(he)风(feng)险比值不(bu)合(he)理;临(lin)(lin)床开发(fa)定位违(wei)背临(lin)(lin)床诊疗、用(yong)(yong)药(yao)的(de)(de)基本原则;已(yi)有(you)的(de)(de)药(yao)学(xue)、临(lin)(lin)床前(qian)研(yan)究(jiu)不(bu)符(fu)合(he)临(lin)(lin)床试验要求(qiu);临(lin)(lin)床试验方(fang)案整体设计严(yan)重缺陷,风(feng)险控制措施不(bu)足;联合(he)用(yong)(yong)药(yao)的(de)(de)非(fei)临(lin)(lin)床研(yan)究(jiu)数据(ju)不(bu)充分;联合(he)疫(yi)苗中单苗的(de)(de)数据(ju)不(bu)充分和(he)(he)/或免疫(yi)程序不(bu)一致(zhi)。

NDA研(yan)发和申报中(zhong)存(cun)在的问(wen)题(ti)主要有(you):研(yan)究质(zhi)量控(kong)制(zhi)和管理存(cun)在缺陷(xian),导致已有(you)的研(yan)究结果(guo)不能证明药(yao)品安全(quan)性(xing)(xing)、有(you)效性(xing)(xing)和质(zhi)量可控(kong)性(xing)(xing);违反合规性(xing)(xing)要求。具(ju)体表(biao)现(xian)包括:关(guan)键临(lin)床研(yan)究设计存(cun)在重大缺陷(xian),无(wu)法(fa)得出客观、有(you)力(li)的有(you)效性(xing)(xing)、安全(quan)性(xing)(xing)证据(ju);药(yao)学研(yan)究存(cun)在严重缺陷(xian),无(wu)法(fa)证明产品的质(zhi)量可控(kong)性(xing)(xing);各开发阶段的研(yan)究受试(shi)样品不一致;注册核查中(zhong)发现(xian)临(lin)床试(shi)验数据(ju)存(cun)在真(zhen)实性(xing)(xing)问(wen)题(ti)。

2.仿制药申请

仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)一致性评(ping)价申(shen)请(qing)(qing)和(he)上市(shi)申(shen)请(qing)(qing)中存在的问题(ti)主要有(you):仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)研发立题(ti)不(bu)合理;申(shen)报(bao)资料(liao)无(wu)法(fa)证明仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)与参比(bi)制(zhi)(zhi)(zhi)剂(被(bei)仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)品(pin))的质(zhi)量一致性。具(ju)体表现(xian)包(bao)括:仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)的参比(bi)制(zhi)(zhi)(zhi)剂已撤市(shi),且已有(you)更(geng)新换代安全性更(geng)好的产品(pin)满足临(lin)床需求;样品(pin)复核(he)检验(yan)不(bu)符合规(gui)定(ding)或分析(xi)方(fang)法(fa)存在严重缺陷;人体生物等效(xiao)性试验(yan)结(jie)果表明不(bu)等效(xiao);样品(pin)稳定(ding)性研究结(jie)果、原(yuan)料(liao)药(yao)(yao)起始物料(liao)选择(ze)等不(bu)符合仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)上市(shi)技术要求;仿(fang)制(zhi)(zhi)(zhi)药(yao)(yao)未按规(gui)定(ding)使用具(ju)有(you)合法(fa)来源的原(yuan)料(liao)药(yao)(yao)。

3.补(bu)充申请

补充(chong)(chong)申(shen)请研究和(he)(he)申(shen)报中存在(zai)的(de)问题主要(yao)有:申(shen)请资料未能充(chong)(chong)分(fen)说(shuo)明(ming)变更的(de)科学性(xing)和(he)(he)合(he)理性(xing),不(bu)足(zu)以(yi)支(zhi)持(chi)(chi)变更事项;已有的(de)研究结果不(bu)能保证(zheng)变更后产品的(de)安全(quan)(quan)性(xing)、有效性(xing)和(he)(he)质量(liang)可控性(xing)。具体(ti)表现包括(kuo):变更引起药用(yong)物质基础发生重大改变;药品说(shuo)明(ming)书(shu)修改申(shen)请不(bu)符(fu)合(he)说(shuo)明(ming)书(shu)撰(zhuan)写的(de)技术要(yao)求;用(yong)于支(zhi)持(chi)(chi)变更的(de)文(wen)献资料存在(zai)偏倚,或者临床安全(quan)(quan)性(xing)和(he)(he)有效性(xing)数据不(bu)充(chong)(chong)分(fen)。

4.其他

其他(ta)药(yao)(yao)(yao)品注(zhu)册申(shen)请在研(yan)发和申(shen)报中存在的问题主(zhu)要有:生物(wu)类似药(yao)(yao)(yao)开发缺少相似性比较数据,药(yao)(yao)(yao)学比对研(yan)究中参照药(yao)(yao)(yao)选(xuan)择存在缺陷(xian);生物(wu)类似药(yao)(yao)(yao)临床(chuang)前研(yan)究结果不足以支持其开展临床(chuang)试验(yan);天然(ran)药(yao)(yao)(yao)物(wu)的研(yan)究资料不符合国(guo)际(ji)多中心临床(chuang)试验(yan)或我国(guo)天然(ran)药(yao)(yao)(yao)物(wu)评(ping)价基本技(ji)术要求。

(七(qi))药品加(jia)快上(shang)市注(zhu)册程(cheng)序(xu)情况(kuang)

创新是推动药(yao)品(pin)(pin)高(gao)质量(liang)(liang)发展的力量(liang)(liang)源泉,《药(yao)品(pin)(pin)注册(ce)管理办法(fa)(fa)》结(jie)合(he)我(wo)国(guo)医药(yao)产业发展和(he)临床需求实(shi)际,参考国(guo)际经(jing)验,设立了特(te)别(bie)(bie)审(shen)(shen)批、突(tu)(tu)破性(xing)治(zhi)疗(liao)药(yao)物(wu)、附条(tiao)件批准、优先审(shen)(shen)评审(shen)(shen)批四个药(yao)品(pin)(pin)加快(kuai)上市(shi)程(cheng)序(xu)。《国(guo)家药(yao)监局(ju)关于发布<突(tu)(tu)破性(xing)治(zhi)疗(liao)药(yao)物(wu)审(shen)(shen)评工(gong)(gong)作程(cheng)序(xu)(试行)>等三个文件的公告》(2020年(nian)第82号),明确(que)了加快(kuai)通道(dao)的适(shi)用(yong)范围、适(shi)用(yong)条(tiao)件、工(gong)(gong)作程(cheng)序(xu)和(he)政(zheng)策支持等,既能显(xian)著(zhu)提高(gao)相关程(cheng)序(xu)执行过程(cheng)中(zhong)的可操作性(xing),鼓励药(yao)物(wu)研制和(he)创新,又(you)能在(zai)全(quan)球抗(kang)击疫(yi)(yi)情(qing)(qing)的大背景(jing)下,依(yi)法(fa)(fa)依(yi)规对疫(yi)(yi)情(qing)(qing)防控所需药(yao)物(wu)实(shi)行特(te)别(bie)(bie)审(shen)(shen)批,对于加快(kuai)临床急需、临床价值突(tu)(tu)出、公共(gong)卫生急需等药(yao)物(wu)的上市(shi)具有重要推动作用(yong)。2020年(nian)已批准上市(shi)药(yao)品(pin)(pin)纳入加快(kuai)上市(shi)程(cheng)序(xu)情(qing)(qing)况详见附件4。

1.特别审批药物(wu)情况(kuang)

在发(fa)生(sheng)突(tu)发(fa)公共(gong)卫生(sheng)事件的威(wei)胁时以(yi)及突(tu)发(fa)公共(gong)卫生(sheng)事件发(fa)生(sheng)后,国家药(yao)监(jian)局(ju)可依法决定(ding)对突(tu)发(fa)公共(gong)卫生(sheng)事件应急所(suo)需(xu)防治药(yao)品(pin)实(shi)行特(te)别审批。纳入实(shi)施特(te)别审批程序的药(yao)物,国家药(yao)监(jian)局(ju)按照统一指(zhi)挥、早期介入、快(kuai)(kuai)速高效、科(ke)学审批的原则,组织加快(kuai)(kuai)并同步开展药(yao)品(pin)注册受理(li)、审评、核查、检验工作,并根据疾病防控的特(te)定(ding)需(xu)要,限(xian)定(ding)其在一定(ding)的期限(xian)和范围内使用。

2020年新(xin)(xin)冠肺(fei)(fei)炎疫情在全球范(fan)围内不断蔓延,人(ren)民群(qun)众的(de)(de)生命安全受到(dao)严重威胁,药审(shen)(shen)中心闻(wen)令(ling)而动,第一时间科学、高(gao)效推进(jin)特(te)别(bie)审(shen)(shen)评工作,按(an)程(cheng)序(xu)将59件中药、化学药、生物制品注(zhu)册申请纳入(ru)特(te)别(bie)审(shen)(shen)批(pi)(pi)程(cheng)序(xu)并完成技(ji)术(shu)审(shen)(shen)评。建(jian)(jian)议(yi)附条件批(pi)(pi)准(zhun)上(shang)市1件,为新(xin)(xin)型冠状病毒灭活(huo)疫苗(Vero细(xi)胞);建(jian)(jian)议(yi)批(pi)(pi)准(zhun)临床试(shi)验申请53件,其中5件已进(jin)入(ru)Ⅲ期临床试(shi)验,批(pi)(pi)准(zhun)化湿败(bai)毒颗(ke)粒(li)、清(qing)肺(fei)(fei)排(pai)毒颗(ke)粒(li)的(de)(de)临床试(shi)验申请;批(pi)(pi)准(zhun)了连花清(qing)瘟(wen)胶囊/颗(ke)粒(li)、金(jin)花清(qing)感颗(ke)粒(li)及血(xue)必净注(zhu)射液等5件增加适应(ying)症的(de)(de)补充(chong)申请,加速(su)了新(xin)(xin)冠病毒疫苗和(he)新(xin)(xin)冠肺(fei)(fei)炎治疗(liao)药物的(de)(de)上(shang)市进(jin)程(cheng),初步满足了新(xin)(xin)冠肺(fei)(fei)炎疫情防控的(de)(de)需(xu)要(yao)。

2.突破性治疗药物情况

突(tu)破(po)性治(zhi)(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)指(zhi)的(de)是(shi)用于防(fang)治(zhi)(zhi)(zhi)(zhi)严重(zhong)危及生(sheng)命或者严重(zhong)影响(xiang)生(sheng)存质量的(de)疾病(bing),且尚无有(you)效防(fang)治(zhi)(zhi)(zhi)(zhi)手(shou)段(duan)或者与现有(you)治(zhi)(zhi)(zhi)(zhi)疗(liao)(liao)手(shou)段(duan)相(xiang)比有(you)足够证据(ju)表明具有(you)明显临床优(you)(you)势(shi)的(de)创新药(yao)(yao)(yao)(yao)(yao)或者改良型新药(yao)(yao)(yao)(yao)(yao)等,申(shen)请人可(ke)在Ⅰ、Ⅱ临床试验阶段(duan)申(shen)请适用突(tu)破(po)性治(zhi)(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)程序(xu)(xu)。根(gen)据(ju)《突(tu)破(po)性治(zhi)(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)审(shen)(shen)评(ping)工作程序(xu)(xu)(试行(xing))》,纳入到“突(tu)破(po)性治(zhi)(zhi)(zhi)(zhi)疗(liao)(liao)”审(shen)(shen)评(ping)通道的(de)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu),药(yao)(yao)(yao)(yao)(yao)审(shen)(shen)中(zhong)心一(yi)是(shi)会(hui)优(you)(you)先(xian)处理相(xiang)关沟通交流,加(jia)强指(zhi)导并(bing)促进药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)研(yan)发(fa)(fa)进程;二是(shi)在申(shen)报上(shang)(shang)市环(huan)节(jie),该药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)可(ke)适用优(you)(you)先(xian)审(shen)(shen)评(ping)审(shen)(shen)批(pi)程序(xu)(xu),审(shen)(shen)评(ping)时限进一(yi)步(bu)缩短;三(san)是(shi)上(shang)(shang)市申(shen)请阶段(duan),药(yao)(yao)(yao)(yao)(yao)审(shen)(shen)中(zhong)心会(hui)滚动接收(shou)其申(shen)报资料,并(bing)优(you)(you)先(xian)安(an)排核查、检验等,可(ke)大大缩减新药(yao)(yao)(yao)(yao)(yao)从研(yan)发(fa)(fa)到上(shang)(shang)市的(de)时间(jian)。2020年药(yao)(yao)(yao)(yao)(yao)审(shen)(shen)中(zhong)心收(shou)到147件突(tu)破(po)性治(zhi)(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)申(shen)请。经(jing)综合评(ping)估、公(gong)示,已(yi)将24件突(tu)破(po)性治(zhi)(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)申(shen)请(21个品(pin)种)纳入突(tu)破(po)性治(zhi)(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)程序(xu)(xu),详见附件5。

3.附条件批准药物情况

附条件(jian)批准上市(shi),目的(de)在于(yu)缩(suo)短药(yao)(yao)物(wu)临床试验的(de)研(yan)发时(shi)间(jian)(jian),使其(qi)尽早应用于(yu)无(wu)法继续等待(dai)的(de)危重疾病或(huo)(huo)公共卫生方面(mian)急需的(de)患者。药(yao)(yao)物(wu)有效性(xing)评价的(de)指(zhi)标为临床终(zhong)点(dian)(dian),符(fu)合附条件(jian)批准上市(shi)情形的(de)药(yao)(yao)物(wu),可使用替代终(zhong)点(dian)(dian)、中间(jian)(jian)临床终(zhong)点(dian)(dian)或(huo)(huo)早期临床试验数据(ju)来(lai)反映药(yao)(yao)物(wu)的(de)有效性(xing),当这些数据(ju)能够提(ti)示药(yao)(yao)品的(de)获益(yi)大于(yu)风险时(shi)候,即可申请附条件(jian)批准上市(shi)。

对(dui)于若不(bu)尽(jin)早进行治疗则会在数(shu)月或者(zhe)更短时间内(nei)导致死亡的疾(ji)(ji)病(bing)患者(zhe)来说,附(fu)条件(jian)批(pi)准上(shang)市的药(yao)物(wu),使得这些无法继(ji)续等待的患者(zhe)能够(gou)延续生(sheng)命、提高生(sheng)存质量,消除(chu)重(zhong)大突发公共(gong)卫(wei)生(sheng)事(shi)件(jian)对(dui)于人(ren)民生(sheng)命安全的威胁。2020年药(yao)审中心(xin)审评通(tong)过的新(xin)药(yao)上(shang)市申请(qing)中,共(gong)有15件(jian)注(zhu)册(ce)申请(qing)经附(fu)条件(jian)批(pi)准后上(shang)市,覆盖了新(xin)型冠状病(bing)毒感染引起的疾(ji)(ji)病(bing)、非小细(xi)胞肺癌、卵巢癌等适应(ying)症。

4.优(you)先审评药物(wu)情况

(1)优先审评(ping)品种纳入情况

《药(yao)品(pin)(pin)(pin)注册(ce)管理办法》对(dui)优先审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)程(cheng)(cheng)序的(de)(de)(de)(de)调整,是(shi)在(zai)多年实践经验基础上的(de)(de)(de)(de)优化(hua)(hua),一(yi)是(shi)适用(yong)范(fan)围更多地向具(ju)有明(ming)显(xian)临床(chuang)价(jia)值(zhi)(zhi)、临床(chuang)急需(xu)(xu)和临床(chuang)优势的(de)(de)(de)(de)药(yao)物(wu)聚焦,致力于(yu)将更多的(de)(de)(de)(de)临床(chuang)价(jia)值(zhi)(zhi)显(xian)著、临床(chuang)急需(xu)(xu)的(de)(de)(de)(de)短缺药(yao)品(pin)(pin)(pin)、防(fang)治重(zhong)大传(chuan)染病(bing)、罕见病(bing)、儿童用(yong)药(yao)、纳入突破性(xing)治疗程(cheng)(cheng)序、符合附条件批(pi)(pi)准(zhun)(zhun)的(de)(de)(de)(de)药(yao)品(pin)(pin)(pin)等纳入优先审(shen)(shen)(shen)评(ping)(ping)程(cheng)(cheng)序;二是(shi)审(shen)(shen)(shen)评(ping)(ping)时(shi)限的(de)(de)(de)(de)加速(su),药(yao)品(pin)(pin)(pin)上市许可申请的(de)(de)(de)(de)审(shen)(shen)(shen)评(ping)(ping)时(shi)限一(yi)般为200个(ge)(ge)工(gong)作日(ri),与完整的(de)(de)(de)(de)申报(bao)路径相比,优先审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)程(cheng)(cheng)序的(de)(de)(de)(de)审(shen)(shen)(shen)评(ping)(ping)时(shi)限缩(suo)短至130个(ge)(ge)工(gong)作日(ri),其中临床(chuang)急需(xu)(xu)境外已上市罕见病(bing)用(yong)药(yao)优先审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)程(cheng)(cheng)序的(de)(de)(de)(de)审(shen)(shen)(shen)评(ping)(ping)时(shi)限为70个(ge)(ge)工(gong)作日(ri)。药(yao)审(shen)(shen)(shen)中心通过优化(hua)(hua)审(shen)(shen)(shen)评(ping)(ping)资源配(pei)置率,在(zai)高标准(zhun)(zhun)完成技术审(shen)(shen)(shen)评(ping)(ping)的(de)(de)(de)(de)前提下(xia),力争按(an)时(shi)限完成审(shen)(shen)(shen)评(ping)(ping),推动(dong)纳入优先审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)程(cheng)(cheng)序中的(de)(de)(de)(de)品(pin)(pin)(pin)种(zhong)尽快获批(pi)(pi)上市。

根(gen)据《药品(pin)注册(ce)(ce)管(guan)理办法(fa)》、46号公告、《国家(jia)食(shi)品(pin)药品(pin)监督管(guan)理总局关于鼓励药品(pin)创(chuang)新实(shi)行(xing)优(you)(you)先(xian)(xian)审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批(pi)的意见》(食(shi)药监药化(hua)管(guan)〔2017〕126号,以下(xia)简称126号文件(jian)),2020年(nian)药审(shen)(shen)(shen)中心将219件(jian)(按(an)通用(yong)名计(ji)127个品(pin)种)注册(ce)(ce)申(shen)(shen)请(qing)纳(na)入(ru)优(you)(you)先(xian)(xian)审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批(pi)程序(xu)。其中,144件(jian)注册(ce)(ce)申(shen)(shen)请(qing)按(an)照(zhao)126号文件(jian)规(gui)定的范围纳(na)入(ru)优(you)(you)先(xian)(xian)审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批(pi)程序(xu),75件(jian)按(an)照(zhao)《药品(pin)注册(ce)(ce)管(guan)理办法(fa)》规(gui)定的范围纳(na)入(ru)优(you)(you)先(xian)(xian)审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批(pi)程序(xu),包括42件(jian)儿童用(yong)药和罕(han)见病用(yong)药。2016-2020年(nian)纳(na)入(ru)优(you)(you)先(xian)(xian)审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批(pi)程序(xu)的各类注册(ce)(ce)申(shen)(shen)请(qing)情况详见表(biao)6和表(biao)7。

   

 

 

  按此(ci)前优先审评(ping)范围(wei)纳入的注册申(shen)请中,同步申(shen)报占比多达44%(64/144),具有(you)明显(xian)临床价值的新药占比为20%,按与原研药质量和疗效(xiao)一致的标准完善后重新申(shen)报品(pin)种占比则由7.9%降至4.2%。

按照《药(yao)品(pin)注(zhu)册管理(li)办法(fa)》优(you)(you)先(xian)审评范围纳(na)入的注(zhu)册申(shen)请中,符合附条件(jian)批(pi)准的药(yao)品(pin)占比为36%(27/75),创新药(yao)和儿童用药(yao)占比28%(21/75),优(you)(you)先(xian)审评资源已向具有明(ming)显临床(chuang)价值(zhi)的创新、急需药(yao)物倾斜(xie)。

(2)优先审(shen)评品种完成情(qing)况

2020年有217件(jian)注册申请(按通用名计121个(ge)品(pin)种(zhong))通过(guo)(guo)优先审评(ping)程(cheng)序(xu)建议批准上市(含已上市药(yao)品(pin)新增适应症),审评(ping)通过(guo)(guo)件(jian)数较2019年增长(zhang)51.7%,例如:我(wo)国自主研发(fa)的(de)1类创新药(yao)甲磺酸阿(a)(a)美替(ti)尼(ni)片、泽布替(ti)尼(ni)胶(jiao)囊(nang)、奥布替(ti)尼(ni)片等,治疗(liao)(liao)罕见(jian)病法布雷病阿(a)(a)加(jia)糖(tang)酶α注射用浓溶液(ye),用于配(pei)合(he)饮食控(kong)制(zhi)及运动(dong)治疗(liao)(liao)2型糖(tang)尿病的(de)中药(yao)新药(yao)桑(sang)枝总生物碱片、间(jian)变性淋巴瘤激酶抑制(zhi)剂盐酸恩沙(sha)替(ti)尼(ni)胶(jiao)囊(nang)、成人复(fu)发(fa)型多发(fa)性硬化治疗(liao)(liao)药(yao)物西尼(ni)莫(mo)德片等。2016-2020年优先审评(ping)通过(guo)(guo)的(de)品(pin)种(zhong)情况详见(jian)表8。

 

(八)药(yao)品注册现(xian)场(chang)核查相关(guan)情况

1.总体情况

药(yao)(yao)审(shen)中心积极(ji)落实(shi)《药(yao)(yao)品注(zhu)(zhu)(zhu)(zhu)册(ce)管理(li)办(ban)法》,转变药(yao)(yao)品注(zhu)(zhu)(zhu)(zhu)册(ce)核(he)(he)查(cha)(cha)(cha)(cha)理(li)念,将注(zhu)(zhu)(zhu)(zhu)册(ce)现(xian)场(chang)(chang)核(he)(he)查(cha)(cha)(cha)(cha)启(qi)(qi)(qi)动(dong)工(gong)作(zuo)(zuo)模式(shi)由(you)基(ji)于(yu)审(shen)评需要调整(zheng)为基(ji)于(yu)风险启(qi)(qi)(qi)动(dong),并联开展技(ji)术审(shen)评与(yu)注(zhu)(zhu)(zhu)(zhu)册(ce)现(xian)场(chang)(chang)核(he)(he)查(cha)(cha)(cha)(cha)工(gong)作(zuo)(zuo);对于(yu)自(zi)2020年(nian)7月1日(ri)(ri)起受(shou)理(li)的注(zhu)(zhu)(zhu)(zhu)册(ce)申请(qing)(qing),在受(shou)理(li)后40个工(gong)作(zuo)(zuo)日(ri)(ri)内决(jue)定是(shi)否启(qi)(qi)(qi)动(dong)相(xiang)应(ying)注(zhu)(zhu)(zhu)(zhu)册(ce)现(xian)场(chang)(chang)核(he)(he)查(cha)(cha)(cha)(cha)任务。为便于(yu)申请(qing)(qing)人及(ji)时获知注(zhu)(zhu)(zhu)(zhu)册(ce)现(xian)场(chang)(chang)核(he)(he)查(cha)(cha)(cha)(cha)启(qi)(qi)(qi)动(dong)相(xiang)关信息(xi),完(wan)善药(yao)(yao)审(shen)中心网站申请(qing)(qing)人之(zhi)窗栏目,开通递交注(zhu)(zhu)(zhu)(zhu)册(ce)现(xian)场(chang)(chang)核(he)(he)查(cha)(cha)(cha)(cha)用生产工(gong)艺与(yu)质(zhi)量标准通道(dao)和查(cha)(cha)(cha)(cha)收注(zhu)(zhu)(zhu)(zhu)册(ce)现(xian)场(chang)(chang)核(he)(he)查(cha)(cha)(cha)(cha)电子(zi)通知函(han)的功能(neng)。

2.注册现(xian)场核查具体情况

2020年,药(yao)(yao)审中心基(ji)于品种因素(su)和(he)研(yan)发生(sheng)产主体合规因素(su)风险(xian)启(qi)动注册现场核(he)(he)查任务(wu)1235个。其中,药(yao)(yao)学现场核(he)(he)查任务(wu)792个,临(lin)床试验数据(ju)核(he)(he)查任务(wu)439个,药(yao)(yao)理(li)毒(du)理(li)研(yan)究核(he)(he)查任务(wu)4个。

药审(shen)中心接收(shou)核(he)查(cha)(cha)报告818份。其中,药学现场核(he)查(cha)(cha)报告449份,临床试验(yan)核(he)查(cha)(cha)报告363份,药理毒理研究核(he)查(cha)(cha)报告6份。

(九)沟通(tong)交流情况

1.总体情况

2020年(nian),药审(shen)(shen)中心在落(luo)实疫(yi)(yi)情防控要求的(de)(de)(de)同(tong)(tong)时,尽量(liang)满(man)足申请(qing)人(ren)的(de)(de)(de)需要,全力(li)保障各(ge)类沟(gou)通(tong)(tong)交流(liu)畅通(tong)(tong)。在推动新(xin)冠(guan)(guan)病(bing)毒疫(yi)(yi)苗(miao)和新(xin)冠(guan)(guan)肺(fei)炎(yan)治疗(liao)(liao)药物(wu)的(de)(de)(de)研发(fa)方面(mian),为79个(ge)(ge)新(xin)冠(guan)(guan)病(bing)毒疫(yi)(yi)苗(miao),中医药、中和抗(kang)(kang)体(27个(ge)(ge))等新(xin)冠(guan)(guan)肺(fei)炎(yan)治疗(liao)(liao)药物(wu),组(zu)织申请(qing)人(ren)与(yu)药审(shen)(shen)中心审(shen)(shen)评(ping)团队之间的(de)(de)(de)沟(gou)通(tong)(tong)交流(liu)5600余次,并针对新(xin)冠(guan)(guan)病(bing)毒疫(yi)(yi)苗(miao)、中和抗(kang)(kang)体等重点品种,单(dan)独(du)设(she)立了(le)台账,动态跟进;在维护(hu)与(yu)申请(qing)人(ren)沟(gou)通(tong)(tong)桥梁方面(mian),药审(shen)(shen)中心发(fa)布了(le)《药物(wu)研发(fa)与(yu)技术审(shen)(shen)评(ping)沟(gou)通(tong)(tong)交流(liu)管理办法》《药审(shen)(shen)中心关于业务(wu)(wu)咨(zi)询(xun)(xun)服务(wu)(wu)联络方式的(de)(de)(de)通(tong)(tong)知》,优(you)化了(le)电话咨(zi)询(xun)(xun)服务(wu)(wu),每天有专(zhuan)人(ren)接听解(jie)答申请(qing)人(ren)咨(zi)询(xun)(xun)电话,根据咨(zi)询(xun)(xun)问(wen)题(ti)类型的(de)(de)(de)不(bu)同(tong)(tong)设(she)立了(le)8个(ge)(ge)联系邮箱,及时解(jie)答处理申请(qing)人(ren)问(wen)题(ti),不(bu)断提(ti)高沟(gou)通(tong)(tong)交流(liu)的(de)(de)(de)质量(liang)和效(xiao)率。

药审中(zhong)心接(jie)(jie)收(shou)沟(gou)通(tong)(tong)交(jiao)流会议申请(qing)3229件,较2019年增(zeng)(zeng)长22.64%,办理沟(gou)通(tong)(tong)交(jiao)流会议申请(qing)2451件,较2019年增(zeng)(zeng)长31.00%。在(zai)网络平(ping)台(tai)接(jie)(jie)收(shou)一(yi)般(ban)性技术问题(ti)咨(zi)(zi)询(xun)20285个,较2019年增(zeng)(zeng)长22.41%;接(jie)(jie)收(shou)电(dian)话(hua)咨(zi)(zi)询(xun)超(chao)过上(shang)万(wan)次(ci),邮件咨(zi)(zi)询(xun)数千件,同时也面向社会提(ti)供现场咨(zi)(zi)询(xun)服务(wu)。2016-2020年接(jie)(jie)收(shou)沟(gou)通(tong)(tong)交(jiao)流申请(qing)和一(yi)般(ban)性技术问题(ti)咨(zi)(zi)询(xun)具体情况详见图16。

 

2.沟通交(jiao)流会(hui)议申请的完成(cheng)情(qing)况

药审(shen)中(zhong)心(xin)所接收的3229件沟通(tong)(tong)交流会议(yi)(yi)(yi)申(shen)(shen)请(qing)中(zhong),符合会议(yi)(yi)(yi)召(zhao)开(kai)条(tiao)件的,及时与(yu)申(shen)(shen)请(qing)人取得了(le)联(lian)系,商议(yi)(yi)(yi)会议(yi)(yi)(yi)细节;无需(xu)召(zhao)开(kai)会议(yi)(yi)(yi)的,以书(shu)面形式尽快回(hui)复了(le)申(shen)(shen)请(qing)人。2020年共(gong)办理了(le)2451件沟通(tong)(tong)交流会议(yi)(yi)(yi)申(shen)(shen)请(qing)。在药物研发关键阶段召(zhao)开(kai)的Ⅱ类会议(yi)(yi)(yi)占比76.42%,其中(zhong)临床(chuang)前(Pre-IND)申(shen)(shen)请(qing)占比37.49%。2020年各类沟通(tong)(tong)交流会议(yi)(yi)(yi)申(shen)(shen)请(qing)及办理情(qing)况详见表9。

 

  沟(gou)(gou)通(tong)(tong)交流(liu)会(hui)议的(de)形(xing)(xing)式为电话(hua)会(hui)议、视频(pin)会(hui)议、面对面会(hui)议,共(gong)召(zhao)开沟(gou)(gou)通(tong)(tong)交流(liu)会(hui)议268次(ci),以书面形(xing)(xing)式回(hui)复(fu)两千(qian)余(yu)件。2018-2020年(nian)各类沟(gou)(gou)通(tong)(tong)交流(liu)会(hui)议的(de)召(zhao)开情(qing)况详见表10。

 

3.一般性技(ji)术问(wen)题答(da)复情(qing)况

药(yao)审中心通过网上咨询(xun)平台(tai)共接收了(le)20285个(ge)(ge)(ge)一(yi)般(ban)性技术问题的咨询(xun)。按照内容分类,问题主要集中于受(shou)理(4038个(ge)(ge)(ge))、原辅包(3952个(ge)(ge)(ge))等方(fang)面(mian);按照药(yao)品分类,问题主要集中于化(hua)(hua)学(xue)药(yao)(11338个(ge)(ge)(ge))方(fang)面(mian),其中化(hua)(hua)学(xue)药(yao)受(shou)理(2396个(ge)(ge)(ge))、化(hua)(hua)学(xue)药(yao)一(yi)致性评价(1258个(ge)(ge)(ge))。一(yi)般(ban)性技术问题答复(fu)具(ju)体(ti)情况详见表11。

 

二(er)、药品注册(ce)申请受理情况

(一)总体情(qing)况

2020年(nian)(nian),根据46号(hao)公告(gao)(gao)、《国家药(yao)监(jian)局(ju)关(guan)于发布生(sheng)物(wu)制品(pin)(pin)注(zhu)(zhu)(zhu)册(ce)分(fen)类及(ji)申报资(zi)料要(yao)(yao)求(qiu)的(de)通(tong)告(gao)(gao)》(2020年(nian)(nian)第(di)43号(hao))、《国家药(yao)监(jian)局(ju)关(guan)于发布化(hua)学药(yao)品(pin)(pin)注(zhu)(zhu)(zhu)册(ce)分(fen)类及(ji)申报资(zi)料要(yao)(yao)求(qiu)的(de)通(tong)告(gao)(gao)》(2020年(nian)(nian)第(di)44号(hao))、《国家药(yao)监(jian)局(ju)关(guan)于发布<中(zhong)(zhong)(zhong)药(yao)注(zhu)(zhu)(zhu)册(ce)分(fen)类及(ji)申报资(zi)料要(yao)(yao)求(qiu)>的(de)通(tong)告(gao)(gao)》(2020年(nian)(nian)第(di)68号(hao))等,药(yao)审(shen)中(zhong)(zhong)(zhong)心(xin)受理中(zhong)(zhong)(zhong)药(yao)、化(hua)学药(yao)、生(sheng)物(wu)制品(pin)(pin)各类注(zhu)(zhu)(zhu)册(ce)申请共10245件(jian)(jian)(含(han)药(yao)械组合(he)产(chan)品(pin)(pin)6件(jian)(jian)),较2019年(nian)(nian)增长26.76%。其(qi)中(zhong)(zhong)(zhong),需技术(shu)审(shen)评(ping)的(de)注(zhu)(zhu)(zhu)册(ce)申请7147件(jian)(jian)(含(han)5695件(jian)(jian)需药(yao)审(shen)中(zhong)(zhong)(zhong)心(xin)技术(shu)审(shen)评(ping)和行政(zheng)(zheng)审(shen)批的(de)注(zhu)(zhu)(zhu)册(ce)申请),较2019年(nian)(nian)增长15.29%;直接(jie)行政(zheng)(zheng)审(shen)批的(de)注(zhu)(zhu)(zhu)册(ce)申请3092件(jian)(jian),较2019年(nian)(nian)增长64.64%。

受(shou)理(li)的10239件药品注册(ce)申(shen)请中,化学(xue)药注册(ce)申(shen)请受(shou)理(li)量为7901件,较2019年(nian)增(zeng)长22.02%,占2020年(nian)全部(bu)注册(ce)申(shen)请受(shou)理(li)量的77.17%,2016-2020年(nian)各类药品注册(ce)申(shen)请受(shou)理(li)情况详(xiang)见图17。

 

2.药审中心的直接(jie)(jie)行(xing)政(zheng)审批(pi)工作自2017年开(kai)始,故2016年无直接(jie)(jie)行(xing)政(zheng)审批(pi)注册申请,所有受(shou)理注册申请均需技术审评。

2020年(nian)受(shou)理的(de)需技(ji)术(shu)审(shen)评的(de)注册(ce)申(shen)(shen)请7147件(jian)中,化学药(yao)注册(ce)申(shen)(shen)请为5402件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长9.42%,占全部(bu)需技(ji)术(shu)审(shen)评的(de)注册(ce)申(shen)(shen)请受(shou)理量的(de)75.58%;中药(yao)注册(ce)申(shen)(shen)请315件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长22.57%;生物制品(pin)注册(ce)申(shen)(shen)请1430件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长42.29%。2016-2020年(nian)需技(ji)术(shu)审(shen)评的(de)中药(yao)、化学药(yao)、生物制品(pin)各(ge)类注册(ce)申(shen)(shen)请受(shou)理情(qing)况详见图18。

 

(二)1类创新药受理(li)情况

2020年(nian),药(yao)审(shen)中(zhong)心受(shou)理(li)1类创新药(yao)注册申请(qing)共(gong)1062件(jian)(597个(ge)品(pin)(pin)(pin)种),较(jiao)2019年(nian)增(zeng)长51.71%。其中(zhong),受(shou)理(li)IND申请(qing)1008件(jian)(559个(ge)品(pin)(pin)(pin)种),较(jiao)2019年(nian)增(zeng)长49.78%;受(shou)理(li)NDA 54件(jian)(38个(ge)品(pin)(pin)(pin)种),较(jiao)2019年(nian)增(zeng)长100.00%。以药(yao)品(pin)(pin)(pin)类别(bie)统计(ji),中(zhong)药(yao)、化学药(yao)、生(sheng)物制(zhi)品(pin)(pin)(pin)1类创新药(yao)受(shou)理(li)量(liang)分别(bie)为14、752、296件(jian)。以生(sheng)产(chan)场地统计(ji),境内生(sheng)产(chan)药(yao)品(pin)(pin)(pin)843件(jian),境外生(sheng)产(chan)药(yao)品(pin)(pin)(pin)219件(jian)。详(xiang)见表(biao)12和13。

 

(三)各类注册申请受(shou)理情况

1.中药注册(ce)申请受理情况

2020年,药(yao)审中(zhong)心(xin)受(shou)理(li)中(zhong)药(yao)注册(ce)申(shen)请471件。其中(zhong),受(shou)理(li)中(zhong)药(yao)IND申(shen)请22件,受(shou)理(li)中(zhong)药(yao)NDA 6件,受(shou)理(li)中(zhong)药(yao)ANDA 1件。2020年中(zhong)药(yao)各(ge)类注册(ce)申(shen)请受(shou)理(li)情况详见图19。

 

  受理(li)1类(lei)中(zhong)药创(chuang)新药注册(ce)申(shen)请14件(jian)。其中(zhong),受理(li)IND 申(shen)请9件(jian)(9个品(pin)种),受理(li)NDA 5件(jian)(5个品(pin)种)。

2.化学药注册(ce)申请受(shou)理(li)情况

2020年(nian)(nian),药(yao)审中心受(shou)理(li)化(hua)(hua)学药(yao)注册(ce)申请(qing)(qing)7901。其中,受(shou)理(li)化(hua)(hua)学药(yao)IND申请(qing)(qing)946件(jian),较2019年(nian)(nian)增长36.31%;受(shou)理(li)化(hua)(hua)学药(yao)NDA 191件(jian),较2019年(nian)(nian)增长46.92%;受(shou)理(li)ANDA 1125件(jian),较2019年(nian)(nian)增长7.45%;受(shou)理(li)一致性评价申请(qing)(qing)914件(jian),较2019年(nian)(nian)减少11.95%。2020年(nian)(nian)化(hua)(hua)学药(yao)各类注册(ce)申请(qing)(qing)受(shou)理(li)情(qing)况(kuang)详见图20。2016-2020年(nian)(nian)化(hua)(hua)学药(yao)各类注册(ce)申请(qing)(qing)受(shou)理(li)情(qing)况(kuang)详见图21。

 

 

药审中心(xin)受理1类创新化学药注册申请(qing)752件(360个品种(zhong)),较2019年(nian)增(zeng)长31.24%。其中,受理IND申请(qing)721件(339个品种(zhong)),较2019年(nian)增(zeng)长30.62%;受理NDA 31件(21个品种(zhong)),较2019年(nian)增(zeng)长47.62%。

药审中(zhong)心受(shou)理化学(xue)药5.1类(lei)注册申请160件(jian),较2019年增(zeng)长1.91%。其中(zhong)受(shou)理临(lin)床(chuang)试(shi)验(yan)申请(验(yan)证性临(lin)床(chuang))53件(jian),受(shou)理NDA 107件(jian)。

360个(ge)品(pin)种的1类创新(xin)化学药注册(ce)申(shen)(shen)请中,境内生产化学药注册(ce)申(shen)(shen)请为258个(ge)品(pin)种,境外生产化学药注册(ce)申(shen)(shen)请为102个(ge)品(pin)种。2016-2020年1类创新(xin)化学药注册(ce)申(shen)(shen)请受理(li)情况详见(jian)图22。

 

3.生物制品注册申请受理情况

2020年,药审中(zhong)心受(shou)理(li)生物(wu)制(zhi)品(pin)(pin)注册申请(qing)(qing)(qing)1867件(jian)(jian)(jian)。其中(zhong),受(shou)理(li)生物(wu)制(zhi)品(pin)(pin)IND申请(qing)(qing)(qing)580件(jian)(jian)(jian)(预(yu)防用(yong)IND申请(qing)(qing)(qing)25件(jian)(jian)(jian),治疗用(yong)IND申请(qing)(qing)(qing)555件(jian)(jian)(jian)),较2019年增(zeng)长87.10%;受(shou)理(li)生物(wu)制(zhi)品(pin)(pin)NDA 126件(jian)(jian)(jian)(预(yu)防用(yong)NDA 7件(jian)(jian)(jian),治疗用(yong)NDA 117件(jian)(jian)(jian),体外诊断试剂(ji)2件(jian)(jian)(jian)),较2019年增(zeng)长1.62%。2020年生物(wu)制(zhi)品(pin)(pin)各类注册申请(qing)(qing)(qing)受(shou)理(li)情况(kuang)详见(jian)图(tu)23。2016-2020年生物(wu)制(zhi)品(pin)(pin)IND申请(qing)(qing)(qing)和(he)NDA受(shou)理(li)情况(kuang)详见(jian)图(tu)24。

 

 

 

药审中心受理(li)(li)1类创新生(sheng)(sheng)物(wu)(wu)制(zhi)品注册申请(qing)296件(223个品种),较(jiao)2019年(nian)增长(zhang)133.07%。其中,受理(li)(li)预防用生(sheng)(sheng)物(wu)(wu)制(zhi)品5件,受理(li)(li)治疗用生(sheng)(sheng)物(wu)(wu)制(zhi)品291件;受理(li)(li)生(sheng)(sheng)物(wu)(wu)制(zhi)品IND申请(qing)278件(211个品种),较(jiao)2019年(nian)增长(zhang)129.75%;受理(li)(li)生(sheng)(sheng)物(wu)(wu)制(zhi)品NDA 18件(12个品种),较(jiao)2019年(nian)增长(zhang)200.00%,具体情况(kuang)详见(jian)表14。

 

4.行政审批注册申请受理情况(kuang)

(1)总(zong)体情况

2020年(nian)(nian)(nian),药(yao)(yao)审(shen)(shen)(shen)(shen)中(zhong)(zhong)心受(shou)理(li)需中(zhong)(zhong)心行(xing)政(zheng)审(shen)(shen)(shen)(shen)批的(de)(de)(de)(de)中(zhong)(zhong)药(yao)(yao)、化学(xue)药(yao)(yao)、生物制品各类注册(ce)申请(qing)(qing)8787件,较(jiao)2019年(nian)(nian)(nian)增长29.51%。其中(zhong)(zhong),受(shou)理(li)需审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批的(de)(de)(de)(de)注册(ce)申请(qing)(qing)(临床试验申请(qing)(qing)、一致(zhi)性评(ping)价申请(qing)(qing)、补充申请(qing)(qing)、境外生产药(yao)(yao)品再注册(ce)及复审(shen)(shen)(shen)(shen))5695件,较(jiao)2019年(nian)(nian)(nian)增长16.06%;受(shou)理(li)直接行(xing)政(zheng)审(shen)(shen)(shen)(shen)批的(de)(de)(de)(de)注册(ce)申请(qing)(qing)(无需技术(shu)审(shen)(shen)(shen)(shen)评(ping)的(de)(de)(de)(de)补充申请(qing)(qing)、临时进口申请(qing)(qing))3092件,较(jiao)2019年(nian)(nian)(nian)增长64.64%。2020年(nian)(nian)(nian)行(xing)政(zheng)审(shen)(shen)(shen)(shen)批注册(ce)申请(qing)(qing)受(shou)理(li)的(de)(de)(de)(de)具体情(qing)况详见表15。2016-2020年(nian)(nian)(nian)行(xing)政(zheng)审(shen)(shen)(shen)(shen)批注册(ce)申请(qing)(qing)受(shou)理(li)情(qing)况详见图25。

 

(2)需审评(ping)审批(pi)的注(zhu)册申请受理情(qing)况

药(yao)审(shen)中心(xin)受理5695件(jian)(jian)需审(shen)评(ping)审(shen)批(pi)的注册申请(qing)中,临床试验(yan)申请(qing)1618件(jian)(jian)(含验(yan)证性(xing)临床)、一致性(xing)评(ping)价申请(qing)914件(jian)(jian)、补(bu)充申请(qing)2827件(jian)(jian)、境外(wai)生产药(yao)品再注册328件(jian)(jian)、复审(shen)8件(jian)(jian)。

(3)直接行政审批的注册(ce)申请受理情况

药(yao)(yao)审(shen)中心受理3092件直接行政(zheng)审(shen)批的注册(ce)申(shen)(shen)请(qing)中,按申(shen)(shen)请(qing)类型(xing)划(hua)分(fen),补充申(shen)(shen)请(qing)2644件、临时进口申(shen)(shen)请(qing)448件。按药(yao)(yao)品类型(xing)划(hua)分(fen),中药(yao)(yao)156件、化学药(yao)(yao)2499件、生物(wu)制品437件。

 三、重点(dian)治疗领(ling)域品种

新(xin)(xin)冠病毒疫(yi)苗和新(xin)(xin)冠肺炎治疗药物:

1.新(xin)型(xing)冠(guan)状(zhuang)病(bing)(bing)(bing)毒灭(mie)活疫(yi)苗(Vero细胞),为国内首个(ge)附条件批准的新(xin)冠(guan)病(bing)(bing)(bing)毒疫(yi)苗,也是全球首个(ge)新(xin)冠(guan)病(bing)(bing)(bing)毒灭(mie)活疫(yi)苗。适用于18岁及以上人群预防由新(xin)型(xing)冠(guan)状(zhuang)病(bing)(bing)(bing)毒(SARS-CoV-2)感染引起(qi)的疾病(bing)(bing)(bing)。

2.“三药(yao)”品种,为《新(xin)型(xing)(xing)冠(guan)(guan)状病(bing)毒(du)肺炎诊(zhen)疗(liao)方案(试行(xing))》推荐药(yao)物,即连(lian)花(hua)清(qing)瘟颗粒(li)/胶囊、金花(hua)清(qing)感颗粒(li)和(he)血必净注(zhu)射液(ye)。连(lian)花(hua)清(qing)瘟颗粒(li)/胶囊和(he)金花(hua)清(qing)感颗粒(li)新(xin)增适应(ying)症用(yong)(yong)于在(zai)新(xin)型(xing)(xing)冠(guan)(guan)状病(bing)毒(du)肺炎的(de)常规治疗(liao)中的(de)轻型(xing)(xing)、普通型(xing)(xing)引起的(de)发热、咳(ke)嗽、乏力,血必净注(zhu)射液(ye)新(xin)增适应(ying)症用(yong)(yong)于新(xin)型(xing)(xing)冠(guan)(guan)状病(bing)毒(du)肺炎重(zhong)(zhong)型(xing)(xing)、危重(zhong)(zhong)型(xing)(xing)的(de)全身炎症反应(ying)综合征(zheng)或/和(he)多(duo)脏器功能衰竭(jie),其获批上市充分发挥了中医(yi)药(yao)在(zai)疫情防控中的(de)作(zuo)用(yong)(yong)。

3.注射用(yong)西(xi)维来司他钠,为中性粒细胞弹性蛋白酶选择性抑制剂,适用(yong)于(yu)改善(shan)伴有(you)全(quan)身性炎症(zheng)反(fan)应综(zong)合征的(de)急性肺损(sun)伤/急性呼吸窘迫综(zong)合征(ALI/ARDS),是全(quan)球(qiu)唯一用(yong)于(yu)ALI/ARDS的(de)药物,其(qi)获批上市(shi)填补了我(wo)(wo)国(guo)ALI/ARDS药物治疗领(ling)域(yu)的(de)空白,为我(wo)(wo)国(guo)呼吸系统(tong)危重(zhong)症(zheng)患者(zhe)提(ti)供用(yong)药选择。

抗(kang)肿瘤药物:

4.甲磺酸(suan)阿(a)美替尼片,为我国首个具有自主知(zhi)识(shi)产权的第(di)三代靶向表皮生(sheng)长(zhang)因子受体(EGFR)小分子酪氨酸(suan)激酶抑制剂(ji)(TKI)创新药物,适用于治疗(liao)既(ji)往经EGFR-TKI治疗(liao)时(shi)或治疗(liao)后出(chu)现疾(ji)病(bing)进展,并(bing)且经检测(ce)确(que)认存在(zai)EGFR T790M突变(bian)阳性(xing)的局部(bu)晚期(qi)或转(zhuan)移(yi)性(xing)非小细胞肺(fei)癌。本(ben)品疗(liao)效突出(chu),脑转(zhuan)移(yi)病(bing)灶(zao)控制良好,其获批上(shang)市将显(xian)著改善(shan)该疾(ji)病(bing)治疗(liao)药物的可及(ji)性(xing)。

5.索(suo)凡替尼(ni)胶囊,为多靶(ba)点、抗血管生成口服小分(fen)子(zi)酪(lao)氨(an)酸激酶抑(yi)制剂,是(shi)国内首个用于治(zhi)疗无法手术(shu)切除的(de)(de)局(ju)部晚期(qi)或(huo)转移性、进展期(qi)非功能性、分(fen)化良好(G1、G2)的(de)(de)非胰腺(xian)来源的(de)(de)神经内分(fen)泌(mi)瘤的(de)(de)创新药物(wu)。本品疗效突出,显著降低了此类(lei)患者的(de)(de)疾(ji)(ji)病进展和死亡风险,其获批上市填补了该(gai)疾(ji)(ji)病治(zhi)疗领域的(de)(de)空白。

6.注射用(yong)维布妥昔单抗(kang),为全球首个CD30靶点抗(kang)体偶(ou)联药(yao)(yao)物(ADC),也(ye)是国(guo)内首个用(yong)于(yu)恶性(xing)淋巴瘤(liu)(liu)患者(zhe)的ADC药(yao)(yao)物,适用(yong)于(yu)治(zhi)疗复发(fa)或难治(zhi)性(xing)的系(xi)统性(xing)间变性(xing)大细胞淋巴瘤(liu)(liu)和经(jing)典型霍奇(qi)金淋巴瘤(liu)(liu),本品(pin)获批上市为改善我国(guo)此(ci)类患者(zhe)的长期生存提供了有效的治(zhi)疗手(shou)段。

7.注射用贝林妥欧单(dan)抗(kang),为全(quan)球首(shou)个(ge)(ge)双(shuang)特异性(xing)(xing)抗(kang)体(CD3和CD19靶点(dian))药(yao)物,也是我国首(shou)个(ge)(ge)用于肿(zhong)瘤适(shi)应(ying)症(zheng)的双(shuang)特异性(xing)(xing)抗(kang)体药(yao)物,适(shi)用于治(zhi)(zhi)疗(liao)成人复发或(huo)难治(zhi)(zhi)性(xing)(xing)前体B细(xi)胞急性(xing)(xing)淋巴细(xi)胞白(bai)血(xue)病(bing)(bing)。对于化疗(liao)失败的复发或(huo)难治(zhi)(zhi)性(xing)(xing)急性(xing)(xing)淋巴细(xi)胞白(bai)血(xue)病(bing)(bing)患(huan)者(zhe),与标准化疗(liao)相比,本品(pin)可显(xian)著延(yan)长患(huan)者(zhe)生存期,其获批上市为我国此类患(huan)者(zhe)提供(gong)了更好的治(zhi)(zhi)疗(liao)手(shou)段。

8.甲磺酸(suan)仑伐(fa)替尼(ni)胶囊,为(wei)多(duo)靶点、口服酪(lao)氨酸(suan)激酶抑制剂,是(shi)国内首个用于治疗(liao)(liao)进展性、局部(bu)晚期(qi)或转移性放射性碘难治性分化(hua)型(xing)甲状腺癌(ai)的(de)小分子药物。本品疗(liao)(liao)效突(tu)出,其获(huo)批上(shang)市为(wei)我(wo)国此类患(huan)者(zhe)提供了(le)有效的(de)治疗(liao)(liao)方案,填补了(le)该(gai)治疗(liao)(liao)领(ling)域(yu)的(de)空(kong)白。

抗感(gan)染(ran)药(yao)物:

9.盐酸可洛派(pai)韦胶囊,为(wei)非结构(gou)蛋白(bai)5A(NS5A)抑制剂(ji),是我(wo)国(guo)具有自主知识产(chan)权(quan)的(de)广谱、直接抗丙肝病(bing)毒创新(xin)药物,适用于与索(suo)磷布韦联(lian)用治疗(liao)初(chu)治或(huo)干扰(rao)素经治的(de)基(ji)因1、2、3、6型成人慢性丙型肝炎病(bing)毒感染(ran),可合并或(huo)不合并代偿性肝硬化,本品获批上市(shi)为(wei)我(wo)国(guo)慢性丙肝患者提供(gong)了(le)一种新(xin)的(de)治疗(liao)选(xuan)择。

10.恩曲他(ta)滨替诺(nuo)福韦片,增加适应症用(yong)于降低(di)成(cheng)人和青少(shao)年(体重(zhong)至少(shao)在(zai)35 kg以上)通(tong)过高风险性(xing)行为获得HIV-1的风险,是(shi)国内首(shou)个用(yong)于暴露前预防(fang)HIV的药物(wu)。HIV感染是(shi)重(zhong)大公共卫生(sheng)问(wen)题,本品获批上市对(dui)于控制HIV传播具有重(zhong)大意义。

循环系统药物:

11.拉(la)那利尤单抗(kang)注射(she)液,为(wei)全人源化(hua)单克隆抗(kang)体(IgG1/K-轻链),是我国首个用于12岁及以上患者(zhe)(zhe)预防(fang)遗传性血管性水(shui)肿(HAE)发作的药物。HAE疾(ji)病反复发作,近半(ban)数患者(zhe)(zhe)可出(chu)现上呼(hu)吸(xi)道黏膜水(shui)肿引发窒息而危及生命,本品获(huo)批上市(shi)为(wei)我国HAE患者(zhe)(zhe)预防(fang)发作提供了安全有效的治(zhi)疗手段。

12.氯苯唑酸软胶囊,为(wei)(wei)转(zhuan)(zhuan)甲(jia)状(zhuang)(zhuang)腺(xian)素(su)蛋(dan)白(TTR)稳(wen)定剂(ji),适用于(yu)治(zhi)疗转(zhuan)(zhuan)甲(jia)状(zhuang)(zhuang)腺(xian)素(su)蛋(dan)白淀粉样变性心(xin)肌病(bing),以减(jian)少心(xin)血管死亡及心(xin)血管相关(guan)住院。该疾病(bing)是一种致命性疾病(bing),属罕见病(bing),本品(pin)为(wei)(wei)我国(guo)首个(ge)针对该病(bing)病(bing)因治(zhi)疗的药物,其获批上市(shi)为(wei)(wei)我国(guo)此类(lei)患者提供了新的治(zhi)疗手段。

呼(hu)吸系统(tong)药(yao)物(wu):

13.苯环喹(kui)溴(xiu)铵鼻(bi)(bi)喷雾剂,为(wei)胆碱(jian)(jian)能(neng)受体拮抗(kang)剂,为(wei)我(wo)国首个具(ju)有(you)自主知识产权用(yong)于变(bian)应(ying)性鼻(bi)(bi)炎的鼻(bi)(bi)用(yong)抗(kang)胆碱(jian)(jian)创新药物,适用(yong)于改善(shan)变(bian)应(ying)性鼻(bi)(bi)炎引(yin)起的流(liu)涕、鼻(bi)(bi)塞(sai)、鼻(bi)(bi)痒和喷嚏症状(zhuang),本品(pin)其获批上市(shi)可为(wei)我(wo)国此类患者(zhe)提供新的治疗选(xuan)择。

14.乙磺(huang)酸(suan)(suan)尼达尼布软胶囊,为小分(fen)子酪氨(an)酸(suan)(suan)激酶抑制(zhi)剂,具有(you)(you)抗纤(xian)(xian)维化(hua)作(zuo)用,增加(jia)适(shi)应(ying)症用于治疗系(xi)统性硬化(hua)病相关间质性肺(fei)疾病(SSc-ILD)和具有(you)(you)进行性表型的(de)慢性纤(xian)(xian)维化(hua)性间质性肺(fei)疾病(PF-ILD)。目前可用于SSc-ILD和PF-ILD的(de)有(you)(you)效治疗方式有(you)(you)限,临床用药需求(qiu)迫切,本(ben)品(pin)获批新增适(shi)应(ying)症可以填补该治疗领域空白(bai),为我国此类患者(zhe)提供药物选择。

神经系统药物:

15.氘丁苯那嗪片,为囊泡单胺(an)转运蛋白2(VMAT2)抑(yi)制剂,是我(wo)国(guo)首个用于治疗与(yu)罕见病亨(heng)廷顿病有关的(de)(de)舞蹈病、迟发性运动障碍的(de)(de)药(yao)物(wu),属临床(chuang)急需境外(wai)新药(yao)名单品种,本品获批上市(shi)满(man)足(zu)了我(wo)国(guo)此类患者迫(po)切的(de)(de)临床(chuang)需求。

16.氯苯唑酸葡胺软胶囊(nang),为转甲(jia)(jia)状(zhuang)腺素(su)蛋(dan)(dan)白(bai)(TTR)稳(wen)定(ding)剂(ji),是(shi)我国首个(ge)用于治疗(liao)成人转甲(jia)(jia)状(zhuang)腺素(su)蛋(dan)(dan)白(bai)淀(dian)粉样变性多(duo)发性神经(jing)病I期症状(zhuang)患(huan)者、延缓周围神经(jing)功能损害的(de)药(yao)物(wu),属临床急(ji)需境外新药(yao)名单品(pin)种(zhong),其获批(pi)上市(shi)改(gai)变了该病无药(yao)可治的(de)局面。

镇(zhen)痛(tong)药及麻醉(zui)科药物:

17.环(huan)泊酚(fen)注(zhu)射(she)(she)液,为GABAA受体激动剂,是用于消化道内(nei)镜(jing)检(jian)查(cha)中(zhong)镇(zhen)静(jing)的(de)创新药(yao)物。本(ben)品与临床常(chang)用麻醉镇(zhen)静(jing)药(yao)物丙泊酚(fen)具(ju)有(you)相(xiang)似的(de)药(yao)理机制(zhi),但(dan)具(ju)有(you)起效快(kuai),注(zhu)射(she)(she)痛(tong)少(shao),呼(hu)吸抑制(zhi)轻,恢(hui)复速(su)度快(kuai)等优(you)势特(te)征,其获批上(shang)市(shi)可为我(wo)国消化内(nei)镜(jing)检(jian)查(cha)操作用药(yao)提供新的(de)选择(ze)。

皮肤(fu)五(wu)官药(yao)物:

18.塞奈吉(ji)明滴眼(yan)液,为国(guo)(guo)内首个(ge)用于治(zhi)(zhi)疗(liao)(liao)神经营养(yang)性角(jiao)膜(mo)炎(yan)(NK)的(de)重组人神经生(sheng)长因子(rhNGF)药物,属临(lin)床急需境外新药名单品种(zhong)。NK为罕见的(de)退(tui)行性角(jiao)膜(mo)疾病(bing),可致(zhi)盲,中重度NK手术治(zhi)(zhi)疗(liao)(liao)为侵入性操作,费用高且(qie)不能永久(jiu)治(zhi)(zhi)愈,本(ben)品获批上(shang)市为我国(guo)(guo)此类患者提(ti)供了有效的(de)治(zhi)(zhi)疗(liao)(liao)药物,预计将成为中重度NK患者的(de)首选治(zhi)(zhi)疗(liao)(liao)。

19.度(du)普利尤单(dan)抗(kang)注(zhu)射液(ye),为(wei)重组人免疫球蛋白-G4单(dan)克(ke)隆抗(kang)体,适用(yong)于治(zhi)疗外(wai)用(yong)处方(fang)药控制不(bu)佳或不(bu)建议使用(yong)外(wai)用(yong)处方(fang)药的(de)成(cheng)人中重度(du)特应性(xing)皮炎,属临(lin)(lin)床(chuang)急需境外(wai)新药名单(dan)品种。与现有(you)治(zhi)疗方(fang)式相比,本品有(you)明显临(lin)(lin)床(chuang)优势,其获批上(shang)市为(wei)此类难治(zhi)性(xing)严重疾病患者(zhe)提供了治(zhi)疗选择。

消(xiao)化系统药物(wu):

20.注射用维得利珠(zhu)单(dan)(dan)抗(kang),为作用于(yu)人(ren)(ren)淋巴细胞(bao)整合素α4β7的(de)人(ren)(ren)源化单(dan)(dan)克(ke)隆(long)抗(kang)体,适用于(yu)治(zhi)疗(liao)(liao)对(dui)传(chuan)统治(zhi)疗(liao)(liao)或肿瘤坏(huai)死因子α(TNF-α)抑制剂应(ying)答(da)不充(chong)分、失(shi)应(ying)答(da)或不耐受的(de)中度至重度活(huo)动性溃疡性结肠炎、克(ke)罗恩病,属临(lin)床急(ji)需境外新(xin)药(yao)名单(dan)(dan)品(pin)种。此类疾病存(cun)在(zai)迫切的(de)临(lin)床治(zhi)疗(liao)(liao)需求,特(te)别是对(dui)于(yu)TNF-α拮抗(kang)剂治(zhi)疗(liao)(liao)失(shi)败的(de)患者(zhe),本品(pin)获(huo)批(pi)上市可为临(lin)床提(ti)供新(xin)的(de)治(zhi)疗(liao)(liao)选择(ze)。

外科(ke)药(yao)物:

21.注(zhu)射用(yong)丹曲(qu)林钠,适(shi)用(yong)于预防及治(zhi)疗恶(e)性(xing)高(gao)热(MH),是目(mu)(mu)前(qian)唯一短(duan)时(shi)间内给药可(ke)改变该疾(ji)病转归(gui)的药物(wu)。MH临床(chuang)结局危重,死亡率高(gao),其获批上市可(ke)改变目(mu)(mu)前(qian)国内MH无安全有效(xiao)治(zhi)疗手段(duan)的现状(zhuang),满足迫切临床(chuang)需求。

22.他(ta)克莫(mo)司颗(ke)粒,适用于(yu)预防儿童肝脏或肾脏移(yi)植术(shu)后的(de)移(yi)植物(wu)排斥反应(ying)(ying),治疗儿童肝脏或肾脏移(yi)植术(shu)后应(ying)(ying)用其(qi)他(ta)免疫抑制药物(wu)无法控制的(de)移(yi)植物(wu)排斥反应(ying)(ying),属儿童用药,本(ben)品(pin)获批上市可(ke)极大解决我国(guo)儿科肝肾移(yi)植患者未满(man)足的(de)临床需求(qiu)。

罕(han)见(jian)病药(yao)物:

23.注射用拉(la)罗尼(ni)酶(mei)浓溶液,为国(guo)内首个用于罕见病(bing)黏多糖(tang)(tang)贮积症(zheng)I型(MPS I,α-L-艾杜糖(tang)(tang)苷(gan)酶(mei)缺乏症(zheng))的酶(mei)替代治疗(liao)药(yao)物(wu),属临床急需(xu)境(jing)外新药(yao)名单(dan)品(pin)(pin)种。黏多糖(tang)(tang)贮积症(zheng)I型是一(yi)种严重危及生命(ming)且(qie)国(guo)内尚无有效治疗(liao)手段的遗传性罕见病(bing),已(yi)列入我国(guo)第(di)一(yi)批罕见病(bing)目录,本(ben)品(pin)(pin)获批上市(shi)填补了我国(guo)此类患者的用药(yao)空白(bai)。

24.艾(ai)度硫酸酯酶(mei)β注射(she)液,为国内(nei)首个(ge)用于罕(han)(han)(han)见(jian)(jian)病黏多糖贮积症Ⅱ型(MPS Ⅱ,亨特(te)综合征)的酶(mei)替代(dai)治(zhi)疗药(yao)物。黏多糖贮积症Ⅱ型是一种严重危及生(sheng)命且(qie)国内(nei)尚无有效治(zhi)疗手段的遗传性(xing)罕(han)(han)(han)见(jian)(jian)病,已列(lie)入我(wo)国第一批罕(han)(han)(han)见(jian)(jian)病目录,本(ben)品获(huo)批上市填补了(le)我(wo)国此类(lei)患者(zhe)的用药(yao)空白。

体内诊(zhen)断试(shi)剂:

25.重(zhong)组(zu)结(jie)核杆(gan)(gan)菌融合蛋白(EC),适用(yong)于6月龄及以(yi)上(shang)婴儿、儿童及65周岁以(yi)下(xia)成(cheng)人(ren)结(jie)核杆(gan)(gan)菌感(gan)染诊(zhen)(zhen)断(duan),并可用(yong)于辅助结(jie)核病的临床诊(zhen)(zhen)断(duan),为全球首个(ge)用(yong)于鉴别(bie)卡介苗接种与(yu)结(jie)核杆(gan)(gan)菌感(gan)染的体内诊(zhen)(zhen)断(duan)产(chan)品,其获批(pi)上(shang)市为临床鉴别(bie)诊(zhen)(zhen)断(duan)提供(gong)了新的手段。

预(yu)防用生物制品(疫苗(miao)):

26.鼻喷冻干流(liu)感(gan)(gan)减毒活疫苗(miao):为(wei)国内首家以鼻喷途径(jing)接(jie)(jie)种的疫苗(miao),适用于(yu)3(36月龄)~17岁人(ren)群用于(yu)预(yu)防(fang)由疫苗(miao)相关型(xing)别(bie)的流(liu)感(gan)(gan)病(bing)毒引(yin)起的流(liu)行性感(gan)(gan)冒,接(jie)(jie)种后可刺激(ji)机体产生抗流(liu)感(gan)(gan)病(bing)毒的免疫力。

中(zhong)药新药:

27.桑(sang)枝(zhi)总(zong)生(sheng)物(wu)碱(jian)片,其主要成分(fen)为(wei)桑(sang)枝(zhi)中提取得到的桑(sang)枝(zhi)总(zong)生(sheng)物(wu)碱(jian),是近10年来(lai)首个获(huo)批上(shang)市的抗糖尿病(bing)(bing)中药(yao)新药(yao),适用于配(pei)合饮食控(kong)制及(ji)运动、治疗2型(xing)糖尿病(bing)(bing)。本(ben)品可有效降(jiang)低2型(xing)糖尿病(bing)(bing)受试者糖化血红蛋白水(shui)平,其获(huo)批上(shang)市为(wei)2型(xing)糖尿病(bing)(bing)患者提供(gong)新的治疗选择。

28.筋骨止(zhi)痛凝(ning)胶,为醋延胡索、川芎(xiong)等12种药(yao)(yao)(yao)味组成的中药(yao)(yao)(yao)复方新(xin)药(yao)(yao)(yao),适用(yong)于膝(xi)骨关节(jie)炎肾虚(xu)筋脉瘀滞证的症(zheng)状改善,具有(you)“活血理气(qi),祛(qu)风(feng)除湿,通络止(zhi)痛”的功效。本品为外用(yong)凝(ning)胶制剂,药(yao)(yao)(yao)物(wu)中各(ge)成分通过透皮(pi)吸收而发挥(hui)作(zuo)用(yong),可避免肠(chang)胃(wei)吸收和肝脏(zang)首过代谢(xie),其获批(pi)上(shang)市可为膝(xi)关节(jie)骨性关节(jie)炎患者提供新(xin)的治疗选择(ze)。

29.连花清咳片(pian),为(wei)麻黄(huang)、桑(sang)白(bai)皮等(deng)15种药味组成的(de)中(zhong)药新药,适用于治疗(liao)急(ji)性气管(guan)-支(zhi)气管(guan)炎(yan)痰(tan)热(re)壅肺(fei)(fei)证引起的(de)咳嗽、咳痰(tan)等(deng),具有(you)“宣(xuan)肺(fei)(fei)泄热(re),化痰(tan)止咳”的(de)功效,其获批上市可(ke)为(wei)急(ji)性气管(guan)-支(zhi)气管(guan)炎(yan)患(huan)者提供(gong)新的(de)治疗(liao)选择。

四、全力做好应(ying)急(ji)审评工作

(一(yi))加强统一(yi)领导,制定(ding)工作程序

按照国(guo)家(jia)药(yao)监(jian)局党组(zu)关(guan)于(yu)疫情防控应急审(shen)评(ping)(ping)审(shen)批工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)部署,药(yao)审(shen)中(zhong)心(xin)闻令而动,一是充分发(fa)挥(hui)集体决策作(zuo)(zuo)(zuo)(zuo)用,迅速成(cheng)立(li)抗新型(xing)(xing)冠(guan)状(zhuang)病(bing)毒(du)药(yao)物(wu)特(te)(te)别审(shen)评(ping)(ping)领(ling)导(dao)小(xiao)组(zu),抽调16个部门148名骨干(gan)力(li)量(liang)为工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)小(xiao)组(zu)成(cheng)员,先后(hou)召(zhao)开(kai)特(te)(te)别审(shen)评(ping)(ping)领(ling)导(dao)小(xiao)组(zu)会议6次和(he)领(ling)导(dao)小(xiao)组(zu)专题会18次,明(ming)晰工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)原则,优化工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)流程(cheng),及时研究解决应急审(shen)评(ping)(ping)过程(cheng)中(zhong)遇到的(de)问题,保(bao)证(zheng)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)顺(shun)利推进、有序(xu)开(kai)展。二是制定工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)程(cheng)序(xu),形成(cheng)1个方案、2个程(cheng)序(xu)、1个规(gui)范(fan),即《药(yao)审(shen)中(zhong)心(xin)抗新型(xing)(xing)冠(guan)状(zhuang)病(bing)毒(du)药(yao)物(wu)特(te)(te)别审(shen)评(ping)(ping)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)方案》《关(guan)于(yu)新型(xing)(xing)冠(guan)状(zhuang)病(bing)毒(du)(2019-nCoV)药(yao)物(wu)立(li)项申请评(ping)(ping)议工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)程(cheng)序(xu)》《关(guan)于(yu)新型(xing)(xing)冠(guan)状(zhuang)病(bing)毒(du)(2019-nCoV)药(yao)物(wu)特(te)(te)别专家(jia)组(zu)评(ping)(ping)估和(he)审(shen)核(he)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)程(cheng)序(xu)》《国(guo)家(jia)药(yao)监(jian)局抗新型(xing)(xing)冠(guan)状(zhuang)病(bing)毒(du)药(yao)物(wu)专家(jia)会议管理规(gui)范(fan)》。三是严格落实“安(an)全守底线(xian)、疗效有证(zheng)据、质量(liang)能保(bao)证(zheng)、审(shen)评(ping)(ping)超常规(gui)”的(de)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)要(yao)求(qiu),按照工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)(zuo)程(cheng)序(xu),依法依规(gui)、科学规(gui)范(fan)审(shen)评(ping)(ping),标准不降,加(jia)速审(shen)批。

(二)发挥专家作用,解决技术难(nan)题

一是组(zu)建特别(bie)专(zhuan)家(jia)(jia)组(zu)。按照《国(guo)(guo)(guo)家(jia)(jia)食品(pin)(pin)药(yao)(yao)品(pin)(pin)监(jian)督管理(li)(li)局药(yao)(yao)品(pin)(pin)特别(bie)审批程序》(原(yuan)国(guo)(guo)(guo)家(jia)(jia)食品(pin)(pin)药(yao)(yao)品(pin)(pin)监(jian)督管理(li)(li)局令第21号)规定(ding)和(he)国(guo)(guo)(guo)家(jia)(jia)药(yao)(yao)监(jian)局新(xin)型冠(guan)状病(bing)毒感染肺炎(yan)疫(yi)情应(ying)对工(gong)作组(zu)药(yao)(yao)品(pin)(pin)组(zu)的决定(ding),药(yao)(yao)审中心(xin)先后(hou)遴选出多位院(yuan)士和(he)知名专(zhuan)家(jia)(jia)组(zu)成(cheng)了特别(bie)专(zhuan)家(jia)(jia)组(zu),经国(guo)(guo)(guo)家(jia)(jia)药(yao)(yao)监(jian)局批准(zhun)后(hou)开展(zhan)工(gong)作。遇到新(xin)的技(ji)术(shu)(shu)难点问(wen)题(ti)时(shi),听取专(zhuan)家(jia)(jia)意(yi)见建议(yi)后(hou),由专(zhuan)家(jia)(jia)投(tou)票表决。二是注重发挥专(zhuan)家(jia)(jia)技(ji)术(shu)(shu)支撑(cheng)作用。通过专(zhuan)家(jia)(jia)研(yan)讨会和(he)专(zhuan)家(jia)(jia)咨询(xun)会解决特定(ding)技(ji)术(shu)(shu)问(wen)题(ti),例如针对mRNA新(xin)冠(guan)病(bing)毒疫(yi)苗在研(yan)发上(shang)存在的难点和(he)潜在的风(feng)险,药(yao)(yao)审中心(xin)组(zu)织专(zhuan)家(jia)(jia)形成(cheng)技(ji)术(shu)(shu)指(zhi)导(dao)原(yuan)则,以指(zhi)导(dao)相关企业的研(yan)发。

(三)实时高效沟通,提高研发进度

一是遵循“早期介入、持续跟进、主动(dong)服务(wu)”的工(gong)作要求,第一时间组(zu)(zu)织(zhi)审评(ping)力量对咨询品种或注册(ce)申(shen)(shen)(shen)(shen)请(qing)立(li)项(xiang)的科学性(xing)和可行性(xing)进行评(ping)议(yi),并(bing)在(zai)24小时内与申(shen)(shen)(shen)(shen)请(qing)人(ren)进行沟通(tong)交流,保证申(shen)(shen)(shen)(shen)请(qing)人(ren)尽(jin)快提交特别审批注册(ce)申(shen)(shen)(shen)(shen)请(qing)。二是加(jia)强国(guo)际(ji)合作。积极参(can)加(jia)世界卫生组(zu)(zu)织(zhi)(WHO)、国(guo)际(ji)药(yao)品监管机构联盟(ICMRA)等组(zu)(zu)织(zhi)召开的视频电话会(hui)议(yi),共同探讨研(yan)发审评(ping)标准,了解新冠病毒疫苗研(yan)发信息,指导推动(dong)研(yan)发企(qi)业赴国(guo)外开展Ⅲ期临床试验。

(四(si))探(tan)索研审联动,坚(jian)持科学审评

一是探(tan)索建立研(yan)发审评(ping)联动工作机制(zhi)。边(bian)研(yan)发、边(bian)提交、边(bian)审评(ping),为(wei)新(xin)冠(guan)病(bing)毒(du)(du)疫(yi)苗研(yan)发争(zheng)取到了宝贵时间,确保(bao)新(xin)冠(guan)病(bing)毒(du)(du)疫(yi)苗等(deng)研(yan)发走在(zai)世界前列。通过这(zhei)种工作机制(zhi),大(da)大(da)缩(suo)短了审评(ping)时间。二(er)是建立技术标准体系。针对新(xin)冠(guan)病(bing)毒(du)(du)的特点,及时制(zhi)定(ding)新(xin)冠(guan)病(bing)毒(du)(du)疫(yi)苗、新(xin)冠(guan)肺炎治(zhi)疗药物研(yan)发技术指(zhi)导(dao)原则等(deng)28个技术文件,指(zhi)导(dao)企业高标准研(yan)发,少走弯路,科(ke)学开展审评(ping)。

 五、鼓励(li)中(zhong)药传承创新发展

贯彻落(luo)实(shi)习近平(ping)总书记(ji)关于(yu)(yu)(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)(de)重(zhong)要(yao)指(zhi)示精神、《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)共中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)央 国(guo)(guo)务(wu)院关于(yu)(yu)(yu)促(cu)进中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)(yao)(yao)(yao)(yao)(yao)传承(cheng)创新(xin)(xin)(xin)(xin)(xin)(xin)发(fa)展(zhan)(zhan)的(de)(de)(de)(de)意(yi)见》及国(guo)(guo)家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)局(ju)(ju)要(yao)求,药(yao)(yao)(yao)(yao)(yao)(yao)(yao)审(shen)(shen)(shen)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)心从改革中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)(zhu)(zhu)册分(fen)类、健(jian)全中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)等(deng)(deng)各方面积极鼓(gu)励中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)守正(zheng)创新(xin)(xin)(xin)(xin)(xin)(xin)。一是推动(dong)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)(de)传承(cheng)发(fa)展(zhan)(zhan)。起(qi)草(cao)并由国(guo)(guo)家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)局(ju)(ju)发(fa)布《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)(zhu)(zhu)册分(fen)类及申(shen)(shen)报(bao)资料(liao)要(yao)求》,丰富(fu)古代经典(dian)名方复方制(zhi)(zhi)剂(ji)的(de)(de)(de)(de)范围(wei),促(cu)进古代经典(dian)名方中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方制(zhi)(zhi)剂(ji)研(yan)(yan)发(fa),推动(dong)其向新(xin)(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)转化。二是建立完(wan)善(shan)符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)(te)点的(de)(de)(de)(de)质(zhi)(zhi)量(liang)控制(zhi)(zhi)体系。遵循中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)(te)点和(he)研(yan)(yan)发(fa)规律,将中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)独特(te)(te)(te)(te)的(de)(de)(de)(de)理(li)论体系和(he)实(shi)践特(te)(te)(te)(te)点、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)剂(ji)质(zhi)(zhi)量(liang)控制(zhi)(zhi)特(te)(te)(te)(te)点与药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品质(zhi)(zhi)量(liang)控制(zhi)(zhi)的(de)(de)(de)(de)一般要(yao)求有机结合(he),研(yan)(yan)究(jiu)构建完(wan)善(shan)符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)剂(ji)特(te)(te)(te)(te)点的(de)(de)(de)(de)质(zhi)(zhi)量(liang)控制(zhi)(zhi)方法和(he)策略,制(zhi)(zhi)定(ding)《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)饮片炮制(zhi)(zhi)研(yan)(yan)究(jiu)指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)(试(shi)(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang)标准(zhun)(zhun)研(yan)(yan)究(jiu)技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)(试(shi)(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方制(zhi)(zhi)剂(ji)生(sheng)产工(gong)(gong)艺研(yan)(yan)究(jiu)技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)(试(shi)(shi)行(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)生(sheng)物效应检测研(yan)(yan)究(jiu)技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)(试(shi)(shi)行(xing))》等(deng)(deng)8个技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)。三(san)是健(jian)全符合(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)(te)点的(de)(de)(de)(de)审(shen)(shen)(shen)评(ping)(ping)体系。引入新(xin)(xin)(xin)(xin)(xin)(xin)工(gong)(gong)具、新(xin)(xin)(xin)(xin)(xin)(xin)方法、新(xin)(xin)(xin)(xin)(xin)(xin)标准(zhun)(zhun)用(yong)于(yu)(yu)(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)疗效评(ping)(ping)价(jia),细化申(shen)(shen)报(bao)资料(liao)要(yao)求,制(zhi)(zhi)定(ding)《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)于(yu)(yu)(yu)慢性便秘临(lin)(lin)(lin)床(chuang)(chuang)研(yan)(yan)究(jiu)技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)(xin)(xin)(xin)(xin)(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)于(yu)(yu)(yu)糖尿病肾(shen)病临(lin)(lin)(lin)床(chuang)(chuang)研(yan)(yan)究(jiu)技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)》等(deng)(deng)技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze),探索构建中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)(yao)(yao)(yao)(yao)(yao)理(li)论、人用(yong)经验(yan)和(he)临(lin)(lin)(lin)床(chuang)(chuang)试(shi)(shi)验(yan)相(xiang)结合(he)的(de)(de)(de)(de)审(shen)(shen)(shen)评(ping)(ping)证据体系。四是全力做好中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)(te)别审(shen)(shen)(shen)评(ping)(ping)工(gong)(gong)作。充分(fen)发(fa)扬抗疫(yi)精神,制(zhi)(zhi)定(ding)了(le)《用(yong)于(yu)(yu)(yu)新(xin)(xin)(xin)(xin)(xin)(xin)冠(guan)肺(fei)(fei)炎中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)(zhu)(zhu)册申(shen)(shen)请特(te)(te)(te)(te)别审(shen)(shen)(shen)批申(shen)(shen)报(bao)资料(liao)要(yao)求(试(shi)(shi)行(xing))》《用(yong)于(yu)(yu)(yu)新(xin)(xin)(xin)(xin)(xin)(xin)冠(guan)肺(fei)(fei)炎中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)(zhu)(zhu)册申(shen)(shen)请特(te)(te)(te)(te)别审(shen)(shen)(shen)批技(ji)(ji)(ji)(ji)术指(zhi)导(dao)(dao)(dao)(dao)原(yuan)则(ze)(试(shi)(shi)行(xing))》等(deng)(deng),指(zhi)导(dao)(dao)(dao)(dao)应急状(zhuang)态下(xia)的(de)(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)审(shen)(shen)(shen)评(ping)(ping)。截至2020年12月(yue)31日,“三(san)方”中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)的(de)(de)(de)(de)清(qing)肺(fei)(fei)排毒颗粒、化湿败毒颗粒的(de)(de)(de)(de)IND申(shen)(shen)请已获批准(zhun)(zhun),“三(san)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)”连(lian)花清(qing)瘟颗粒/胶(jiao)囊、金花清(qing)感颗粒、血必净注(zhu)(zhu)(zhu)射液获批增加(jia)用(yong)于(yu)(yu)(yu)治(zhi)疗新(xin)(xin)(xin)(xin)(xin)(xin)冠(guan)肺(fei)(fei)炎的(de)(de)(de)(de)适应症。五是赴武汉开展(zhan)(zhan)实(shi)地调(diao)研(yan)(yan)和(he)座谈,持(chi)续推进中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)监(jian)管(guan)科(ke)学“以(yi)临(lin)(lin)(lin)床(chuang)(chuang)价(jia)值为导(dao)(dao)(dao)(dao)向的(de)(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)安(an)全性评(ping)(ping)价(jia)研(yan)(yan)究(jiu)”课题研(yan)(yan)究(jiu)。六(liu)是开展(zhan)(zhan)援疆援藏(zang)工(gong)(gong)作,赴西藏(zang)开展(zhan)(zhan)实(shi)地调(diao)研(yan)(yan)、与新(xin)(xin)(xin)(xin)(xin)(xin)疆维吾尔自治(zhi)区药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品监(jian)督管(guan)理(li)局(ju)(ju)召(zhao)开线(xian)上座谈交流会,支持(chi)民族药(yao)(yao)(yao)(yao)(yao)(yao)(yao)发(fa)展(zhan)(zhan)。

  六、加强《药品注册管理办法》配套文件(jian)制(zhi)修订

新修(xiu)订的(de)《药(yao)(yao)品(pin)注(zhu)册(ce)(ce)管(guan)(guan)理办法(fa)》是(shi)贯彻(che)党中央(yang)、国务院审评(ping)审批制(zhi)度改革精神和落实新修(xiu)订《药(yao)(yao)品(pin)管(guan)(guan)理法(fa)》的(de)重要(yao)规章,考(kao)虑到药(yao)(yao)品(pin)注(zhu)册(ce)(ce)管(guan)(guan)理中的(de)具体技术(shu)(shu)要(yao)求(qiu),需(xu)要(yao)跟(gen)随技术(shu)(shu)发(fa)(fa)展的(de)脚步不断调整完善,在规章中不适宜作出具体的(de)规定,因此这些具体技术(shu)(shu)要(yao)求(qiu)在《药(yao)(yao)品(pin)注(zhu)册(ce)(ce)管(guan)(guan)理办法(fa)》发(fa)(fa)布后,以配套文件、技术(shu)(shu)指导原则等形(xing)式发(fa)(fa)布,既能更好地顺(shun)应药(yao)(yao)品(pin)研(yan)发(fa)(fa)的(de)科学规律,也能确保新旧(jiu)《药(yao)(yao)品(pin)注(zhu)册(ce)(ce)管(guan)(guan)理办法(fa)》的(de)平稳过渡和新《药(yao)(yao)品(pin)注(zhu)册(ce)(ce)管(guan)(guan)理办法(fa)》的(de)顺(shun)利(li)实施。

根据国(guo)家局部署,药审中心统(tong)筹协调(diao),加大配(pei)套文(wen)件(jian)(jian)的制修(xiu)订力度,成(cheng)(cheng)(cheng)立(li)课题组(zu),对重点难点问(wen)题开展(zhan)调(diao)研攻(gong)关(guan),充分(fen)听取专家、业(ye)界意见(jian),力求(qiu)达成(cheng)(cheng)(cheng)共(gong)识,共(gong)参与了48个配(pei)套文(wen)件(jian)(jian)制修(xiu)订工(gong)作(zuo),其(qi)中牵头起草配(pei)套文(wen)件(jian)(jian)30个。自开展(zhan)工(gong)作(zuo)以来(lai),已基本(ben)完(wan)成(cheng)(cheng)(cheng)配(pei)套文(wen)件(jian)(jian)公开征求(qiu)意见(jian)工(gong)作(zuo),部分(fen)文(wen)件(jian)(jian)已经(jing)国(guo)家局审核同意后发布实施,有效确保了各项审评任(ren)务不断(duan)、不散、不乱,新旧注册相关(guan)规定的顺(shun)利过渡和实施。

 七、加快审评技术标准体系建设

在药(yao)品(pin)审评和研发过程(cheng)中,指(zhi)导(dao)原(yuan)则(ze)兼具(ju)监管依(yi)据和技(ji)术要(yao)求的双重(zhong)职能。《药(yao)品(pin)注册管理办法》明(ming)确(que)从事(shi)药(yao)物研制和药(yao)品(pin)注册活动,应(ying)当遵守(shou)有关法律、法规、规章、标准(zhun)和规范;药(yao)审中心(xin)等(deng)专(zhuan)业(ye)技(ji)术机构,应(ying)当根据科学(xue)进展、行业(ye)发展实际和药(yao)品(pin)监督管理工作(zuo)需(xu)要(yao)制定技(ji)术指(zhi)导(dao)原(yuan)则(ze)和程(cheng)序,并向社会公布。

药(yao)品技(ji)术(shu)(shu)指(zhi)导原(yuan)(yuan)则体(ti)系的(de)建(jian)立与完善,是落实“四个最(zui)严(yan)”要求的(de)最(zui)好实践,是药(yao)审(shen)中心(xin)推进(jin)审(shen)评(ping)体(ti)系和(he)审(shen)评(ping)能力(li)现(xian)代化的(de)重要举(ju)措。药(yao)审(shen)中心(xin)通过(guo)“定(ding)标(biao)准、定(ding)程序、定(ding)计(ji)划(hua)”三步走的(de)方式,统筹规划(hua)以指(zhi)导原(yuan)(yuan)则为核心(xin)的(de)审(shen)评(ping)标(biao)准体(ti)系建(jian)设,围(wei)绕(rao)药(yao)品研发(fa)需求和(he)鼓励创(chuang)新的(de)原(yuan)(yuan)则,对标(biao)国际(ji)先进(jin)监管机构技(ji)术(shu)(shu)标(biao)准,加大指(zhi)导原(yuan)(yuan)则制(zhi)(zhi)定(ding)和(he)公开力(li)度。2020年共开展(zhan)了(le)119个技(ji)术(shu)(shu)指(zhi)导原(yuan)(yuan)则制(zhi)(zhi)修订工(gong)作,根据《国家(jia)药(yao)监局(ju)(ju)综合(he)司关于印发(fa)药(yao)品技(ji)术(shu)(shu)指(zhi)导原(yuan)(yuan)则发(fa)布程序的(de)通知》(药(yao)监综药(yao)管〔2020〕9号)要求,截(jie)至2020年12月31日,药(yao)审(shen)中心(xin)已经国家(jia)药(yao)监局(ju)(ju)审(shen)查同意发(fa)布了(le)71个指(zhi)导原(yuan)(yuan)则,详见附件6。

在(zai)应对(dui)新型冠状病毒肺(fei)炎(yan)、促进(jin)新冠病毒疫苗(miao)和(he)新冠肺(fei)炎(yan)治疗(liao)药(yao)(yao)(yao)物(wu)(wu)(wu)(wu)的(de)(de)研(yan)(yan)(yan)发(fa)(fa)和(he)审评(ping)(ping)质(zhi)量(liang)、速度方(fang)面,药(yao)(yao)(yao)审中(zhong)(zhong)心发(fa)(fa)布了(le)(le)《新型冠状病毒预防用(yong)疫苗(miao)研(yan)(yan)(yan)发(fa)(fa)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(试(shi)行)》等(deng)(deng)7个指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze);在(zai)着力提(ti)升(sheng)中(zhong)(zhong)药(yao)(yao)(yao)材质(zhi)量(liang)研(yan)(yan)(yan)究(jiu),鼓(gu)励中(zhong)(zhong)药(yao)(yao)(yao)研(yan)(yan)(yan)发(fa)(fa)与创新方(fang)面,发(fa)(fa)布了(le)(le)《中(zhong)(zhong)药(yao)(yao)(yao)新药(yao)(yao)(yao)用(yong)药(yao)(yao)(yao)材质(zhi)量(liang)控制研(yan)(yan)(yan)究(jiu)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(试(shi)行)》《中(zhong)(zhong)药(yao)(yao)(yao)复(fu)方(fang)制剂生产工(gong)艺研(yan)(yan)(yan)究(jiu)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(试(shi)行)》《中(zhong)(zhong)药(yao)(yao)(yao)新药(yao)(yao)(yao)用(yong)于慢(man)性便秘临(lin)床研(yan)(yan)(yan)究(jiu)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)》等(deng)(deng)10个指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze);在(zai)鼓(gu)励儿(er)(er)童药(yao)(yao)(yao)物(wu)(wu)(wu)(wu)研(yan)(yan)(yan)发(fa)(fa)方(fang)面,发(fa)(fa)布了(le)(le)《真实世界研(yan)(yan)(yan)究(jiu)支(zhi)持(chi)儿(er)(er)童药(yao)(yao)(yao)物(wu)(wu)(wu)(wu)研(yan)(yan)(yan)发(fa)(fa)与审评(ping)(ping)的(de)(de)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(试(shi)行)》等(deng)(deng)3个指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze);在(zai)支(zhi)持(chi)抗(kang)(kang)肿瘤药(yao)(yao)(yao)物(wu)(wu)(wu)(wu)研(yan)(yan)(yan)发(fa)(fa),进(jin)一(yi)(yi)步满足申(shen)请人(ren)对(dui)具体(ti)抗(kang)(kang)肿瘤药(yao)(yao)(yao)物(wu)(wu)(wu)(wu)的(de)(de)个药(yao)(yao)(yao)指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)需求方(fang)面,发(fa)(fa)布了(le)(le)《抗(kang)(kang)肿瘤药(yao)(yao)(yao)联合治疗(liao)临(lin)床试(shi)验技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)》《注射用(yong)曲妥珠单抗(kang)(kang)生物(wu)(wu)(wu)(wu)类似(si)药(yao)(yao)(yao)临(lin)床试(shi)验指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)》等(deng)(deng)22个指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze);在(zai)提(ti)高仿(fang)制药(yao)(yao)(yao)质(zhi)量(liang),推进(jin)仿(fang)制药(yao)(yao)(yao)一(yi)(yi)致性评(ping)(ping)价方(fang)面,规范(fan)审评(ping)(ping)标准和(he)尺度,发(fa)(fa)布了(le)(le)《化(hua)学药(yao)(yao)(yao)品(pin)注射剂仿(fang)制药(yao)(yao)(yao)质(zhi)量(liang)和(he)疗(liao)效一(yi)(yi)致性评(ping)(ping)价技(ji)(ji)(ji)术(shu)(shu)要(yao)求》《化(hua)学药(yao)(yao)(yao)品(pin)注射剂(特殊注射剂)仿(fang)制药(yao)(yao)(yao)质(zhi)量(liang)和(he)疗(liao)效一(yi)(yi)致性评(ping)(ping)价技(ji)(ji)(ji)术(shu)(shu)要(yao)求》等(deng)(deng)9个指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)。这(zhei)些指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)覆盖新冠应急(ji)审评(ping)(ping)标准、儿(er)(er)童用(yong)药(yao)(yao)(yao)、中(zhong)(zhong)药(yao)(yao)(yao)民(min)族药(yao)(yao)(yao)技(ji)(ji)(ji)术(shu)(shu)标准体(ti)系、抗(kang)(kang)肿瘤药(yao)(yao)(yao)物(wu)(wu)(wu)(wu)研(yan)(yan)(yan)发(fa)(fa)及仿(fang)制药(yao)(yao)(yao)研(yan)(yan)(yan)发(fa)(fa)等(deng)(deng)热点难(nan)点问(wen)题,持(chi)续完(wan)善药(yao)(yao)(yao)品(pin)技(ji)(ji)(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)体(ti)系,有效推动药(yao)(yao)(yao)物(wu)(wu)(wu)(wu)研(yan)(yan)(yan)发(fa)(fa)创新,不断优化(hua)统(tong)一(yi)(yi)审评(ping)(ping)尺度,大力提(ti)升(sheng)审评(ping)(ping)质(zhi)量(liang)和(he)效率,显著减(jian)少审评(ping)(ping)自由裁(cai)量(liang)权(quan)。

 八、持续深(shen)化(hua)药品审评审批(pi)制度改革

(一)加快境外已上市临(lin)床(chuang)急需(xu)新药审评

深入(ru)贯(guan)彻国(guo)务院常务会(hui)议精神,落实加快(kuai)境外(wai)已上市(shi)临床(chuang)急需(xu)新药(yao)审评要(yao)求(qiu),在确(que)定了(le)第(di)一二批(pi)(pi)(pi)74个(ge)品(pin)种(zhong)名(ming)单的(de)基础上,国(guo)家(jia)(jia)药(yao)监(jian)局(ju)、国(guo)家(jia)(jia)卫(wei)生健(jian)康委(wei)(wei)组织(zhi)有(you)关(guan)专家(jia)(jia)研究论证,遴(lin)选临床(chuang)急需(xu)新药(yao)品(pin)种(zhong),药(yao)审中心发布了(le)第(di)三(san)批(pi)(pi)(pi)7个(ge)品(pin)种(zhong)名(ming)单。对(dui)于(yu)(yu)符合《国(guo)家(jia)(jia)药(yao)品(pin)监(jian)督管(guan)理局(ju) 国(guo)家(jia)(jia)卫(wei)生健(jian)康委(wei)(wei)员会(hui)关(guan)于(yu)(yu)临床(chuang)急需(xu)境外(wai)新药(yao)审评审批(pi)(pi)(pi)相关(guan)事宜的(de)公告》(2018年第(di)79号)规定情形的(de)品(pin)种(zhong),国(guo)家(jia)(jia)药(yao)监(jian)局(ju)会(hui)同国(guo)家(jia)(jia)卫(wei)生健(jian)康委(wei)(wei)已组织(zhi)进行了(le)充分遴(lin)选,基本解决了(le)临床(chuang)急需(xu)境外(wai)已上市(shi)新药(yao)在我国(guo)上市(shi)速度较慢的(de)问题(ti),进一步提高(gao)了(le)公众用药(yao)的(de)可及性。

2020年,药(yao)(yao)审(shen)中心完(wan)成(cheng)(cheng)(cheng)了13个(ge)用于治疗罕(han)见(jian)病的、临床(chuang)急需的药(yao)(yao)品(pin)的技术审(shen)评,均在(zai)规(gui)定时限内完(wan)成(cheng)(cheng)(cheng),罕(han)见(jian)病药(yao)(yao)品(pin)在(zai)3个(ge)月之内完(wan)成(cheng)(cheng)(cheng)审(shen)评,其他临床(chuang)急需药(yao)(yao)品(pin)在(zai)6个(ge)月之内完(wan)成(cheng)(cheng)(cheng)审(shen)评,大大缩短了临床(chuang)急需境外(wai)(wai)新药(yao)(yao)在(zai)我国上(shang)市(shi)的时间差(cha)距。截至2020年12月31日(ri),已(yi)发布的三批(pi)81个(ge)品(pin)种临床(chuang)急需境外(wai)(wai)已(yi)上(shang)市(shi)新药(yao)(yao)中,已(yi)有38家企业的48个(ge)品(pin)种提(ti)出(chu)注(zhu)册申请,其中39个(ge)品(pin)种已(yi)获(huo)批(pi)上(shang)市(shi)或完(wan)成(cheng)(cheng)(cheng)审(shen)评,100%在(zai)时限内完(wan)成(cheng)(cheng)(cheng)审(shen)评工作,详见(jian)附件7。

(二)加速推动仿制药一致性评(ping)价工作

2020年(nian),药审中(zhong)心采取切实有效措(cuo)施加速推进仿(fang)制药一致性评价工(gong)作。

一(yi)(yi)(yi)是在口服固体制剂(ji)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)工(gong)(gong)作的基(ji)础上(shang),积极推进(jin)注(zhu)(zhu)射(she)剂(ji)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)工(gong)(gong)作。国(guo)家药(yao)(yao)监(jian)局于(yu)5月12日发布《关(guan)于(yu)开展化学药(yao)(yao)品(pin)注(zhu)(zhu)射(she)剂(ji)仿(fang)制药(yao)(yao)质量和疗效(xiao)(xiao)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)工(gong)(gong)作的公告》(2020年第(di)62号),正(zheng)式启动注(zhu)(zhu)射(she)剂(ji)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)工(gong)(gong)作。药(yao)(yao)审(shen)(shen)中心发布《化学药(yao)(yao)品(pin)注(zhu)(zhu)射(she)剂(ji)仿(fang)制药(yao)(yao)质量和疗效(xiao)(xiao)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)技术要求(qiu)》《化学药(yao)(yao)品(pin)注(zhu)(zhu)射(she)剂(ji)仿(fang)制药(yao)(yao)质量和疗效(xiao)(xiao)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)申(shen)报(bao)资料要求(qiu)》和《化学药(yao)(yao)品(pin)注(zhu)(zhu)射(she)剂(ji)(特殊注(zhu)(zhu)射(she)剂(ji))仿(fang)制药(yao)(yao)质量和疗效(xiao)(xiao)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)技术要求(qiu)》等技术要求(qiu)。针对正(zheng)式启动前已(yi)有620件待审(shen)(shen)评(ping)的注(zhu)(zhu)射(she)剂(ji)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)申(shen)请(qing),药(yao)(yao)审(shen)(shen)中心成立专项审(shen)(shen)评(ping)工(gong)(gong)作组(zu),采取细(xi)化分类处理措施,严格执行(xing)一(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)发补,明确注(zhu)(zhu)射(she)剂(ji)一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)注(zhu)(zhu)册检查(cha)的随机原则(ze),加快审(shen)(shen)评(ping)速度,在不到(dao)5个月的时间内完成了(le)620件品(pin)种的审(shen)(shen)评(ping),一(yi)(yi)(yi)致性(xing)(xing)(xing)评(ping)价(jia)按时限(xian)审(shen)(shen)评(ping)已(yi)进(jin)入(ru)常态化。

二是继续规(gui)(gui)范参(can)(can)比(bi)制(zhi)剂(ji)遴(lin)选(xuan)工(gong)作(zuo),强化(hua)(hua)服(fu)务与指导。药(yao)审中心(xin)发布(bu)《化(hua)(hua)学仿制(zhi)药(yao)参(can)(can)比(bi)制(zhi)剂(ji)遴(lin)选(xuan)申请(qing)资料要求》(药(yao)审中心(xin)通告2020年第32号),进一步强调申请(qing)人(ren)的自(zi)查环节,提高参(can)(can)比(bi)制(zhi)剂(ji)遴(lin)选(xuan)工(gong)作(zuo)效率。通过进一步规(gui)(gui)范内部审核(he)、专家(jia)委员会审核(he)等流程,2020年优化(hua)(hua)了参(can)(can)比(bi)制(zhi)剂(ji)遴(lin)选(xuan)工(gong)作(zuo)。自(zi)2017年8月开展一致(zhi)性评价工(gong)作(zuo)以来共发布(bu)参(can)(can)比(bi)制(zhi)剂(ji)目录(lu)35批,涉及3963个(ge)品规(gui)(gui)(1703个(ge)品种),其(qi)中包括注(zhu)射剂(ji)参(can)(can)比(bi)制(zhi)剂(ji)975个(ge)品规(gui)(gui)(405个(ge)品种)。

三是加(jia)强(qiang)信(xin)息公开和培训。2020年(nian)7月举(ju)办线上化学(xue)仿制(zhi)(zhi)药(yao)注(zhu)射(she)剂(ji)一致性评价技(ji)术研讨会,对注(zhu)射(she)剂(ji)一致性评价技(ji)术要求、特(te)殊注(zhu)射(she)剂(ji)技(ji)术要求、参比(bi)制(zhi)(zhi)剂(ji)申请资料要求等进行(xing)宣讲(jiang)。

四是(shi)持续推进(jin)生(sheng)物(wu)(wu)等(deng)效(xiao)性试(shi)验(yan)备案工作。2020年化(hua)学药生(sheng)物(wu)(wu)等(deng)效(xiao)性试(shi)验(yan)备案平(ping)台(tai)共收集了672条记录,仿制药一致性评价生(sheng)物(wu)(wu)等(deng)效(xiao)性试(shi)验(yan)备案平(ping)台(tai)共收集了292条记录。

(三)全面落(luo)实临床试验期间风险(xian)管(guan)理

为落实《药(yao)(yao)品(pin)(pin)管(guan)理(li)(li)(li)(li)法》《药(yao)(yao)品(pin)(pin)注册管(guan)理(li)(li)(li)(li)办法》中(zhong)有(you)关临(lin)(lin)床(chuang)(chuang)(chuang)试(shi)(shi)验(yan)期(qi)(qi)间(jian)(jian)安(an)(an)(an)全(quan)(quan)风(feng)(feng)险管(guan)理(li)(li)(li)(li)工作,药(yao)(yao)审(shen)中(zhong)心在国家(jia)药(yao)(yao)监局(ju)指导下(xia),发布了《药(yao)(yao)物(wu)(wu)临(lin)(lin)床(chuang)(chuang)(chuang)试(shi)(shi)验(yan)期(qi)(qi)间(jian)(jian)安(an)(an)(an)全(quan)(quan)信(xin)(xin)息(xi)(xi)评(ping)估与管(guan)理(li)(li)(li)(li)规范(试(shi)(shi)行(xing))》、《研发期(qi)(qi)间(jian)(jian)安(an)(an)(an)全(quan)(quan)性(xing)更(geng)新报告管(guan)理(li)(li)(li)(li)规范(试(shi)(shi)行(xing))》和(he)《药(yao)(yao)物(wu)(wu)临(lin)(lin)床(chuang)(chuang)(chuang)试(shi)(shi)验(yan)登(deng)记及信(xin)(xin)息(xi)(xi)公示管(guan)理(li)(li)(li)(li)规范(试(shi)(shi)行(xing))》3个配(pei)套文件(jian)。为进一步加强临(lin)(lin)床(chuang)(chuang)(chuang)试(shi)(shi)验(yan)过程(cheng)的(de)(de)安(an)(an)(an)全(quan)(quan)信(xin)(xin)息(xi)(xi)监测、识(shi)别、评(ping)估和(he)风(feng)(feng)险控制(zhi),制(zhi)定了《药(yao)(yao)品(pin)(pin)审(shen)评(ping)中(zhong)心药(yao)(yao)物(wu)(wu)临(lin)(lin)床(chuang)(chuang)(chuang)试(shi)(shi)验(yan)期(qi)(qi)间(jian)(jian)安(an)(an)(an)全(quan)(quan)信(xin)(xin)息(xi)(xi)评(ping)估与风(feng)(feng)险管(guan)理(li)(li)(li)(li)工作程(cheng)序(试(shi)(shi)行(xing))》,上线运行(xing)“临(lin)(lin)床(chuang)(chuang)(chuang)试(shi)(shi)验(yan)期(qi)(qi)间(jian)(jian)安(an)(an)(an)全(quan)(quan)风(feng)(feng)险管(guan)理(li)(li)(li)(li)系(xi)统”,对临(lin)(lin)床(chuang)(chuang)(chuang)试(shi)(shi)验(yan)期(qi)(qi)间(jian)(jian)的(de)(de)安(an)(an)(an)全(quan)(quan)信(xin)(xin)息(xi)(xi),如(ru)可疑且非预期(qi)(qi)严重(zhong)不(bu)良反(fan)应(SUSAR)和(he)研发期(qi)(qi)间(jian)(jian)安(an)(an)(an)全(quan)(quan)性(xing)更(geng)新报告(DSUR)等开展全(quan)(quan)过程(cheng)信(xin)(xin)息(xi)(xi)系(xi)统化的(de)(de)风(feng)(feng)险评(ping)估。

2020年(nian)药(yao)审中(zhong)(zhong)心接(jie)收(shou)(shou)来(lai)自国内外的(de)SUSAR个(ge)例(li)报(bao)(bao)告164403份(涉及病例(li)为57995例(li))。其中(zhong)(zhong),来(lai)自中(zhong)(zhong)国的(de)SUSAR个(ge)例(li)报(bao)(bao)告17243份(涉及病例(li)为4647例(li));接(jie)收(shou)(shou)DSUR共(gong)计1775份;完(wan)成临床试验(yan)登记2610项(含新(xin)冠(guan)病毒疫苗和新(xin)冠(guan)肺炎(yan)治(zhi)疗药(yao)物)。对18个(ge)药(yao)物临床试验(yan)中(zhong)(zhong)存在的(de)安全性(xing)风(feng)(feng)险(xian),提出(chu)了进一步(bu)的(de)风(feng)(feng)险(xian)控制(zhi)处理意见,包括一般风(feng)(feng)险(xian)控制(zhi)(如修改临床试验(yan)方案(an)、修改知情同意书、修改研究者手册、补充完(wan)善风(feng)(feng)险(xian)控制(zhi)措施)和建议申请人主动暂停临床试验(yan)等。

面对(dui)突如其来的严重(zhong)新冠(guan)肺(fei)炎(yan)疫情,药(yao)审中心探(tan)索建立了(le)申请人进行临(lin)床(chuang)(chuang)试(shi)(shi)验进展信息报(bao)告(gao)机(ji)制(zhi)与(yu)通道,规(gui)范了(le)相关工作程序与(yu)技(ji)术要求,发布了(le)《新冠(guan)肺(fei)炎(yan)疫情期(qi)间药(yao)物(wu)临(lin)床(chuang)(chuang)试(shi)(shi)验管理指导原则(ze)(试(shi)(shi)行)》,制(zhi)定了(le)规(gui)范统(tong)一的《应急(ji)审批(pi)(pi)(pi)品(pin)种(zhong)临(lin)床(chuang)(chuang)试(shi)(shi)验进展和安全监测工作文件》。通过(guo)每日和每周的动(dong)态风险(xian)沟通交(jiao)流,实施有效的风险(xian)监测与(yu)风险(xian)控(kong)制(zhi)。对(dui)2020年(nian)2月2日至2020年(nian)12月31日经特别审批(pi)(pi)(pi)程序批(pi)(pi)(pi)准15个(ge)疫苗、16个(ge)生(sheng)物(wu)制(zhi)品(pin)、6个(ge)化学(xue)药(yao)、2个(ge)中药(yao)的临(lin)床(chuang)(chuang)试(shi)(shi)验共(gong)39个(ge)品(pin)种(zhong)实施动(dong)态安全监测,完成了(le)应急(ji)审批(pi)(pi)(pi)新冠(guan)病毒疫苗及新冠(guan)肺(fei)炎(yan)治(zhi)疗(liao)药(yao)物(wu)临(lin)床(chuang)(chuang)试(shi)(shi)验进展及安全性监测报(bao)告(gao)共(gong)195份(fen)。

药审(shen)中心参(can)加《药物警戒质量管(guan)理规范(fan)》(GVP)的起草工作(zuo)(zuo),撰写临(lin)床试(shi)验(yan)期(qi)间(jian)药物警戒相关内容和(he)要求(qiu)。完成《临(lin)床试(shi)验(yan)期(qi)间(jian)安全信(xin)息(xi)管(guan)理:国际医学(xue)科学(xue)组织(zhi)理事会(hui)(CIOMS)VI工作(zuo)(zuo)组报告》的翻译与(yu)出版(ban)工作(zuo)(zuo),召开(kai)“疫情期(qi)间(jian)临(lin)床试(shi)验(yan)管(guan)理及远(yuan)(yuan)程智能技术(shu)(shu)应用学(xue)术(shu)(shu)交流视频会(hui)议”,探索(suo)开(kai)展远(yuan)(yuan)程智能化临(lin)床试(shi)验(yan)的安全管(guan)理工作(zuo)(zuo),稳步提(ti)升临(lin)床试(shi)验(yan)期(qi)间(jian)安全信(xin)息(xi)评估(gu)和(he)风险管(guan)理能力。

(四(si))继(ji)续夯实审评(ping)科学基础建设

1.审(shen)评质量管理体系建设

发挥审(shen)评质量(liang)管(guan)理体(ti)(ti)系(xi)对(dui)(dui)(dui)药品(pin)审(shen)评工作(zuo)(zuo)(zuo)持续有效(xiao)运行(xing)(xing)的(de)(de)保障作(zuo)(zuo)(zuo)用(yong)。一方面是应对(dui)(dui)(dui)新(xin)法(fa)律规章实(shi)施对(dui)(dui)(dui)审(shen)评业务(wu)工作(zuo)(zuo)(zuo)带来(lai)(lai)的(de)(de)风险和挑战,结合《药品(pin)注册(ce)管(guan)理办法(fa)》及其配套文件要求,及时组(zu)织对(dui)(dui)(dui)《质量(liang)手册(ce)》等体(ti)(ti)系(xi)文件进行(xing)(xing)全面修订,加强药品(pin)审(shen)评业务(wu)与质量(liang)体(ti)(ti)系(xi)的(de)(de)结合;另一方面是应对(dui)(dui)(dui)新(xin)冠(guan)肺炎疫情对(dui)(dui)(dui)审(shen)评工作(zuo)(zuo)(zuo)带来(lai)(lai)的(de)(de)影响,通过(guo)开展药审(shen)中心专项(xiang)内(nei)部监督(du)检查,充分锻(duan)炼药审(shen)中心内(nei)审(shen)员队伍,及时发现存在的(de)(de)风险并组(zu)织改进;同时持续开展年(nian)度满意度调查工作(zuo)(zuo)(zuo),收集国家药监局和申请人对(dui)(dui)(dui)药审(shen)中心在落实(shi)新(xin)注册(ce)相(xiang)关要求、应对(dui)(dui)(dui)新(xin)冠(guan)肺炎疫情风险防控时的(de)(de)意见和建(jian)议,为提高审(shen)评质量(liang)和效(xiao)率提供(gong)思(si)路,发挥质量(liang)体(ti)(ti)系(xi)对(dui)(dui)(dui)各项(xiang)工作(zuo)(zuo)(zuo)的(de)(de)支持作(zuo)(zuo)(zuo)用(yong)。

2.强(qiang)化(hua)审评信息化(hua)建设(she)

为确保(bao)(bao)各项审(shen)(shen)(shen)(shen)评(ping)(ping)改革工(gong)作执行过程(cheng)(cheng)中(zhong)的(de)规范化(hua)、标准化(hua)、数字化(hua),药(yao)(yao)(yao)审(shen)(shen)(shen)(shen)中(zhong)心大力推(tui)进信息化(hua)建设,依据《药(yao)(yao)(yao)品(pin)(pin)注册(ce)管(guan)(guan)理(li)(li)(li)办法》和(he)(he)流程(cheng)(cheng)为导向的(de)科学管(guan)(guan)理(li)(li)(li)体系,以药(yao)(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)业(ye)务(wu)流程(cheng)(cheng)为基础,立足工(gong)作实(shi)(shi)际,对药(yao)(yao)(yao)品(pin)(pin)技术(shu)审(shen)(shen)(shen)(shen)评(ping)(ping)系统升级完善。新增发(fa)补(bu)(bu)前的(de)专(zhuan)业(ye)审(shen)(shen)(shen)(shen)评(ping)(ping)问(wen)询和(he)(he)发(fa)补(bu)(bu)后的(de)补(bu)(bu)充(chong)资料问(wen)询平台(tai),优化(hua)沟通(tong)交流系统,加强审(shen)(shen)(shen)(shen)评(ping)(ping)期(qi)间与申(shen)请人(ren)(ren)的(de)主动(dong)(dong)沟通(tong)交流,促进审(shen)(shen)(shen)(shen)评(ping)(ping)业(ye)务(wu)工(gong)作开(kai)(kai)展;新增异议(yi)处理(li)(li)(li)审(shen)(shen)(shen)(shen)核和(he)(he)注册(ce)检验网(wang)络通(tong)道(dao),调整(zheng)优先审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批系统,强化(hua)审(shen)(shen)(shen)(shen)核流程(cheng)(cheng)可(ke)操作性,保(bao)(bao)障审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批工(gong)作顺(shun)利实(shi)(shi)施。开(kai)(kai)通(tong)受(shou)理(li)(li)(li)网(wang)上预约通(tong)道(dao),减少人(ren)(ren)员(yuan)流动(dong)(dong)聚(ju)集(ji),有效保(bao)(bao)障新冠肺炎疫情期(qi)间申(shen)请人(ren)(ren)受(shou)理(li)(li)(li)业(ye)务(wu)的(de)有序办理(li)(li)(li);增加突破(po)性治疗药(yao)(yao)(yao)物程(cheng)(cheng)序,为鼓励创新和(he)(he)加快(kuai)临(lin)床急(ji)需品(pin)(pin)种上市(shi)拓(tuo)宽审(shen)(shen)(shen)(shen)评(ping)(ping)通(tong)道(dao)。通(tong)过信息化(hua)手段助力药(yao)(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批业(ye)务(wu)管(guan)(guan)理(li)(li)(li),强化(hua)网(wang)络信息安全保(bao)(bao)障,不断提升药(yao)(yao)(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批工(gong)作质(zhi)量(liang)和(he)(he)效率。目(mu)前药(yao)(yao)(yao)审(shen)(shen)(shen)(shen)中(zhong)心网(wang)站申(shen)请人(ren)(ren)之窗实(shi)(shi)名注册(ce)申(shen)请企业(ye)10674家,基本实(shi)(shi)现了(le)药(yao)(yao)(yao)品(pin)(pin)、原(yuan)料药(yao)(yao)(yao)、辅料、包(bao)材注册(ce)申(shen)请人(ren)(ren)网(wang)上业(ye)务(wu)办理(li)(li)(li)的(de)全覆(fu)盖。

(五(wu))积极推进流(liu)程导向(xiang)科学管理体系建设

为贯彻党的十九届四中(zhong)、五中(zhong)全(quan)(quan)会精神(shen),加强(qiang)治(zhi)理(li)(li)(li)体(ti)系(xi)、治(zhi)理(li)(li)(li)能力建设(she)(she),以流程导(dao)向科学(xue)(xue)管(guan)理(li)(li)(li)体(ti)系(xi)建设(she)(she)为抓手(shou),不断推(tui)进药品审(shen)评(ping)体(ti)系(xi)和审(shen)评(ping)能力的现代化。按(an)照(zhao)前(qian)期(qi)工作计划,药审(shen)中(zhong)心(xin)已全(quan)(quan)面铺开任务受理(li)(li)(li)、任务分配(pei)、专业审(shen)评(ping)、综合审(shen)评(ping)、沟通交(jiao)流、专家咨(zi)询、书面发补、核查检(jian)验共8个子课题(ti)的科学(xue)(xue)管(guan)理(li)(li)(li)体(ti)系(xi)试点(dian)建设(she)(she),并印发《药审(shen)中(zhong)心(xin)关(guan)于运行(xing)药品专业审(shen)评(ping)流程导(dao)向科学(xue)(xue)管(guan)理(li)(li)(li)体(ti)系(xi)有关(guan)问题(ti)的通知》等8个文件,制定科学(xue)(xue)管(guan)理(li)(li)(li)体(ti)系(xi)制度制修订计划(含28项制度),截至2020年12月31日已完成14项。注重试点(dian)建设(she)(she)成果的信(xin)息化,将各项措施(shi)纳入审(shen)评(ping)信(xin)息系(xi)统,增强(qiang)措施(shi)执行(xing)的刚性约束,提高了科学(xue)(xue)监管(guan)和智慧(hui)审(shen)评(ping)能力。

形成按季度汇(hui)报机制,定期(qi)组织汇(hui)报试点(dian)运行(xing)(xing)情况(kuang)。建(jian)立了(le)(le)改革措施管理(li)台账,纳入了(le)(le)58项(xiang)需要监督的(de)(de)改革措施,按月度对每(mei)项(xiang)改革措施实施的(de)(de)责任(ren)落实、进(jin)(jin)(jin)展(zhan)情况(kuang)、新问题和解决建(jian)议(yi)予以一体(ti)化动态管理(li)。召开(kai)了(le)(le)试点(dian)推进(jin)(jin)(jin)座谈会、子课题结题座谈会,对各子课题试点(dian)进(jin)(jin)(jin)度、成效、问题等进(jin)(jin)(jin)行(xing)(xing)总结分析。建(jian)立了(le)(le)促(cu)进(jin)(jin)(jin)试点(dian)建(jian)设的(de)(de)长效运行(xing)(xing)机制,常态化、一体(ti)化推进(jin)(jin)(jin)科学(xue)审评(ping)、高效审评(ping)和廉洁审评(ping)。

(六)持续开展ICH工作

切实推进我国(guo)药(yao)(yao)品(pin)审(shen)评审(shen)批体系与(yu)(yu)国(guo)际(ji)接轨,参与(yu)(yu)ICH指(zhi)(zhi)导原则(ze)(ze)的(de)国(guo)际(ji)协(xie)调。一是(shi)积极参与(yu)(yu)ICH议题(ti)(ti)协(xie)调工(gong)(gong)(gong)作(zuo),自原国(guo)家食品(pin)药(yao)(yao)品(pin)监(jian)督管理总局(ju)(ju)2017年加入ICH以(yi)来,已向36个(ge)ICH工(gong)(gong)(gong)作(zuo)组(zu)(zu)派(pai)出了(le)69名(ming)专(zhuan)家,2020年参与(yu)(yu)ICH工(gong)(gong)(gong)作(zuo)组(zu)(zu)电话会(hui)437场。二是(shi)进一步推进ICH三级指(zhi)(zhi)导原则(ze)(ze)实施工(gong)(gong)(gong)作(zuo),国(guo)家药(yao)(yao)监(jian)局(ju)(ju)共(gong)发布(bu)了(le)3个(ge)ICH指(zhi)(zhi)导原则(ze)(ze)适用及(ji)推荐适用公告。三是(shi)组(zu)(zu)织开(kai)展ICH指(zhi)(zhi)导原则(ze)(ze)培(pei)训(xun)(xun)工(gong)(gong)(gong)作(zuo),药(yao)(yao)审(shen)中(zhong)心开(kai)展ICH指(zhi)(zhi)导原则(ze)(ze)线上(shang)培(pei)训(xun)(xun)共(gong)15场,主要(yao)围绕29个(ge)ICH指(zhi)(zhi)导原则(ze)(ze)的(de)技术要(yao)点、实施现状、实施过程(cheng)中(zhong)可能存在(zai)的(de)问(wen)题(ti)(ti)等内容进行宣(xuan)贯。培(pei)训(xun)(xun)对象主要(yao)包括(kuo)国(guo)家药(yao)(yao)监(jian)局(ju)(ju)相关司局(ju)(ju)、各(ge)直属单(dan)位(wei)、各(ge)省(sheng)级药(yao)(yao)监(jian)局(ju)(ju)和省(sheng)级药(yao)(yao)检(jian)机构的(de)相关工(gong)(gong)(gong)作(zuo)人(ren)(ren)员,共(gong)计(ji)2723人(ren)(ren)观看培(pei)训(xun)(xun)直播,4244人(ren)(ren)观看直播回放。四(si)是(shi)召开(kai)ICH指(zhi)(zhi)导原则(ze)(ze)和协(xie)调议题(ti)(ti)研讨会(hui),为广泛听取行业及(ji)学界专(zhuan)家意见,2020年药(yao)(yao)审(shen)中(zhong)心共(gong)召开(kai)ICH国(guo)内专(zhuan)家研讨会(hui)15场,共(gong)计(ji)312人(ren)(ren)参会(hui)。

(七(qi))加(jia)强(qiang)审评队伍建设和管理

加强(qiang)审评(ping)队(dui)伍建(jian)设,畅通审评(ping)员(yuan)职业发(fa)展通道,开(kai)展主审审评(ping)员(yuan)认定工(gong)作;完善聘(pin)(pin)期考(kao)核评(ping)价(jia)体系,加强(qiang)员(yuan)工(gong)聘(pin)(pin)期考(kao)核工(gong)作;开(kai)展补充(chong)性招(zhao)聘(pin)(pin),引(yin)进临床(chuang)、统计等(deng)紧缺专业人(ren)才;加强(qiang)员(yuan)工(gong)培训(xun),组织开(kai)展《药品注册(ce)管理(li)办法(fa)》及配套文件系列讲座、实训(xun)、英语口语等(deng)培训(xun)。

  九、加强服务指导、改(gai)进(jin)工作效率和作风

2020年,药(yao)审中心驰而不息强化作风建设,积极(ji)服务药(yao)品高(gao)质量发展新要求。

一(yi)是(shi)紧密围(wei)绕(rao)新(xin)冠(guan)肺(fei)炎疫(yi)情(qing)防(fang)(fang)控大局(ju),超常(chang)规创新(xin)开展应急审(shen)评审(shen)批,加强审(shen)评服(fu)务(wu)保(bao)(bao)障,全(quan)力(li)做(zuo)好新(xin)冠(guan)病毒(du)疫(yi)苗(miao)(miao)(miao)审(shen)评过程(cheng)中(zhong)的(de)(de)(de)各项工(gong)作。面(mian)对(dui)新(xin)冠(guan)肺(fei)炎疫(yi)情(qing)对(dui)新(xin)冠(guan)病毒(du)疫(yi)苗(miao)(miao)(miao)药(yao)(yao)物的(de)(de)(de)急迫(po)需求,药(yao)(yao)审(shen)中(zhong)心(xin)坚持尊重科学规律,建立(li)早(zao)期(qi)介入(ru),持续跟踪,主(zhu)动(dong)(dong)服(fu)务(wu)、研(yan)审(shen)联(lian)动(dong)(dong)的(de)(de)(de)工(gong)作机制,始终(zhong)保(bao)(bao)持24小(xiao)时(shi)与(yu)企(qi)业畅通沟通的(de)(de)(de)状态(tai),无论多晚,即使是(shi)凌晨3-4点钟,都会第(di)一(yi)时(shi)间反馈(kui)研(yan)发(fa)企(qi)业诉求,在推动(dong)(dong)境外(wai)临(lin)床试验上(shang)强化担当,在创新(xin)审(shen)评审(shen)批中(zhong)挖潜增效,成功高效推动(dong)(dong)国(guo)(guo)药(yao)(yao)集团新(xin)冠(guan)病毒(du)疫(yi)苗(miao)(miao)(miao)附条(tiao)件批准上(shang)市和(he)5个疫(yi)苗(miao)(miao)(miao)品种进(jin)入(ru)Ⅲ期(qi)临(lin)床试验,确保(bao)(bao)中(zhong)国(guo)(guo)新(xin)冠(guan)病毒(du)疫(yi)苗(miao)(miao)(miao)走在世界前列,及(ji)时(shi)有(you)力(li)支撑了疫(yi)情(qing)防(fang)(fang)控大局(ju)。同时(shi)贯彻落(luo)实习近平(ping)总书记坚持中(zhong)西(xi)医结合、中(zhong)西(xi)药(yao)(yao)并用的(de)(de)(de)重要指(zhi)示精神(shen),主(zhu)动(dong)(dong)对(dui)接临(lin)床救治中(zhong)应用的(de)(de)(de)“三(san)药(yao)(yao)三(san)方”生产(chan)企(qi)业和(he)研(yan)发(fa)单位,积(ji)极做(zuo)好有(you)效中(zhong)药(yao)(yao)方剂转(zhuan)化产(chan)品注(zhu)册和(he)临(lin)床试验申请技术(shu)指(zhi)导,确保(bao)(bao)中(zhong)药(yao)(yao)第(di)一(yi)时(shi)间用于新(xin)冠(guan)肺(fei)炎患者救治。这些成果不仅确保(bao)(bao)了防(fang)(fang)疫(yi)的(de)(de)(de)应急所需,还为(wei)常(chang)态(tai)化疫(yi)情(qing)防(fang)(fang)控准备了重要的(de)(de)(de)战略资源(yuan),不仅提振了国(guo)(guo)人战胜疫(yi)情(qing)的(de)(de)(de)信心(xin),还为(wei)全(quan)球疫(yi)情(qing)防(fang)(fang)控贡献了中(zhong)国(guo)(guo)力(li)量。

二是(shi)强(qiang)化服(fu)(fu)务(wu)申(shen)(shen)请(qing)人(ren)(ren)(ren)沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)。在新冠肺炎疫情(qing)防控常(chang)态化的(de)(de)(de)(de)情(qing)况(kuang)下(xia),全(quan)面落(luo)实新冠肺炎疫情(qing)联防联控措施,最(zui)大限(xian)度减(jian)少人(ren)(ren)(ren)员(yuan)流(liu)(liu)(liu)(liu)(liu)动聚集,阻断疫情(qing)传播扩(kuo)散渠(qu)道,切实保障申(shen)(shen)请(qing)人(ren)(ren)(ren)的(de)(de)(de)(de)生命安(an)全(quan)和身体健康(kang),暂停现场咨询业(ye)务(wu)的(de)(de)(de)(de)同(tong)时(shi)开通(tong)(tong)(tong)(tong)(tong)(tong)(tong)了(le)电话咨询业(ye)务(wu)。增(zeng)设(she)立了(le)8个联系(xi)邮箱,申(shen)(shen)请(qing)人(ren)(ren)(ren)可(ke)以(yi)邮件咨询问题并提供在审品(pin)种受(shou)(shou)(shou)理(li)(li)号等(deng)信息,项目管(guan)(guan)理(li)(li)人(ren)(ren)(ren)员(yuan)将在3个工作日内(nei)与(yu)该受(shou)(shou)(shou)理(li)(li)号相关(guan)的(de)(de)(de)(de)申(shen)(shen)请(qing)人(ren)(ren)(ren)进行联系(xi)。通(tong)(tong)(tong)(tong)(tong)(tong)(tong)过不断丰富和拓(tuo)展沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)的(de)(de)(de)(de)渠(qu)道和方式,服(fu)(fu)务(wu)和便(bian)利(li)申(shen)(shen)请(qing)人(ren)(ren)(ren);为鼓励创新,更好地体现沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)的(de)(de)(de)(de)服(fu)(fu)务(wu)属性,结合《药(yao)品(pin)注册管(guan)(guan)理(li)(li)办(ban)(ban)法(fa)》,从药(yao)物研(yan)制规律(lv)和注册要求出发,秉持为药(yao)品(pin)注册申(shen)(shen)请(qing)人(ren)(ren)(ren)服(fu)(fu)务(wu)的(de)(de)(de)(de)原(yuan)则,修订后发布(bu)了(le)《药(yao)物研(yan)发与(yu)技术(shu)审评(ping)沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)管(guan)(guan)理(li)(li)办(ban)(ban)法(fa)》。在保证受(shou)(shou)(shou)试(shi)者安(an)全(quan)性的(de)(de)(de)(de)基础上(shang)(shang),将Ⅱ类(lei)会议划分为依法(fa)应沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)、原(yuan)则上(shang)(shang)应当沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)、可(ke)以(yi)沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)三类(lei)情(qing)形,并明(ming)确和细化了(le)三类(lei)沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)的(de)(de)(de)(de)情(qing)形和要求;为提高(gao)沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)申(shen)(shen)请(qing)办(ban)(ban)理(li)(li)的(de)(de)(de)(de)可(ke)预见性和效率(lv),药(yao)审中心通(tong)(tong)(tong)(tong)(tong)(tong)(tong)过持续优化沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)管(guan)(guan)理(li)(li),细化环节时(shi)限(xian)控制,确保了(le)申(shen)(shen)请(qing)人(ren)(ren)(ren)能够(gou)尽(jin)快享受(shou)(shou)(shou)到优质(zhi)的(de)(de)(de)(de)沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)服(fu)(fu)务(wu),努力满足申(shen)(shen)请(qing)人(ren)(ren)(ren)逐年增(zeng)加的(de)(de)(de)(de)沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)需求,将2020年沟(gou)通(tong)(tong)(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)申(shen)(shen)请(qing)办(ban)(ban)理(li)(li)量(liang)(liang)提升(sheng)至2019年办(ban)(ban)理(li)(li)量(liang)(liang)的(de)(de)(de)(de)1.31倍(bei),这也是(shi)2016年办(ban)(ban)理(li)(li)量(liang)(liang)的(de)(de)(de)(de)11.35倍(bei)。

三(san)是(shi)持续改(gai)善内部工作作风(feng),提高(gao)工作效(xiao)率(lv)。这一(yi)(yi)年药(yao)(yao)审(shen)(shen)(shen)中(zhong)心继(ji)续深化审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)制度改(gai)革(ge),持续优(you)化审(shen)(shen)(shen)评(ping)(ping)流程,严格时限管(guan)理,实施审(shen)(shen)(shen)评(ping)(ping)任务(wu)分析会制度,加强项(xiang)目督(du)导(dao),鼓(gu)励药(yao)(yao)品创新(xin),推动仿制药(yao)(yao)高(gao)质(zhi)量发(fa)(fa)展(zhan),审(shen)(shen)(shen)评(ping)(ping)质(zhi)量和效(xiao)率(lv)有了(le)极大地提升,2020年全(quan)(quan)年审(shen)(shen)(shen)结任务(wu)整体按时完成(cheng)(cheng)率(lv)创历(li)史(shi)新(xin)高(gao)。药(yao)(yao)品审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)的可预期性进一(yi)(yi)步提高(gao),顺利完成(cheng)(cheng)《十三(san)五药(yao)(yao)品安(an)全(quan)(quan)规(gui)划》涉(she)及药(yao)(yao)品审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)改(gai)革(ge)目标。通过5年来深化药(yao)(yao)品审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)(pi)制度改(gai)革(ge)的不懈(xie)努力,药(yao)(yao)审(shen)(shen)(shen)中(zhong)心实现(xian)了(le)量变到质(zhi)变的飞跃,药(yao)(yao)品平均审(shen)(shen)(shen)评(ping)(ping)时限大幅压缩,审(shen)(shen)(shen)评(ping)(ping)能力大幅提升,一(yi)(yi)大批(pi)(pi)创新(xin)药(yao)(yao)、临床(chuang)急(ji)需(xu)药(yao)(yao)获批(pi)(pi)上市,累计(ji)通过和视(shi)同通过一(yi)(yi)致性评(ping)(ping)价(jia)审(shen)(shen)(shen)评(ping)(ping)的品种已达445个,为十四五药(yao)(yao)品审(shen)(shen)(shen)评(ping)(ping)事(shi)业的发(fa)(fa)展(zhan)奠(dian)定了(le)坚实的基础。

药审(shen)(shen)中(zhong)心(xin)将深入梳理在提高审(shen)(shen)评效率、创新审(shen)(shen)评方(fang)(fang)式等(deng)方(fang)(fang)面的(de)经验做法,使应急状态下的(de)临时性(xing)措施,有(you)序(xu)地上升为常态化(hua)审(shen)(shen)评工作长效机制,将被动(dong)选(xuan)择(ze)但被实践证明长期有(you)效的(de)方(fang)(fang)法转(zhuan)化(hua)为常态化(hua)条件(jian)下提高审(shen)(shen)评能(neng)力的(de)主动(dong)选(xuan)择(ze)。

十、加大药品审评审批信息公开(kai)力(li)度

药审(shen)(shen)(shen)(shen)中心持(chi)续推(tui)进(jin)技(ji)术审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)的(de)信(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)工(gong)作,提高药品审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批工(gong)作透(tou)明度(du)。一是完善信(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)制度(du),发(fa)布了《药品审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批信(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)管理办(ban)法》,明确信(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)的(de)范围、种(zhong)类、时限等要(yao)求(qiu),为做(zuo)好(hao)信(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)工(gong)作提供了制度(du)依据。二是大力推(tui)动新(xin)(xin)药技(ji)术审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)报(bao)告的(de)公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai),自(zi)开(kai)(kai)(kai)展工(gong)作以来已(yi)完成(cheng)公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)新(xin)(xin)药技(ji)术审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)报(bao)告316个,指导(dao)行业研发(fa),更(geng)好(hao)的(de)服务(wu)药品注(zhu)册申(shen)(shen)请(qing)(qing)人(ren)(ren)和公(gong)(gong)(gong)(gong)(gong)众。三是加(jia)大技(ji)术审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)过(guo)程信(xin)息(xi)(xi)(xi)(xi)(xi)公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)力度(du),通(tong)(tong)过(guo)药审(shen)(shen)(shen)(shen)中心网站向申(shen)(shen)请(qing)(qing)人(ren)(ren)进(jin)一步公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)了审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)排队信(xin)息(xi)(xi)(xi)(xi)(xi)、优(you)先审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)的(de)状态信(xin)息(xi)(xi)(xi)(xi)(xi)、沟通(tong)(tong)交(jiao)流(liu)申(shen)(shen)请(qing)(qing)及办(ban)理信(xin)息(xi)(xi)(xi)(xi)(xi)等信(xin)息(xi)(xi)(xi)(xi)(xi),新(xin)(xin)增了“突(tu)破性治疗(liao)公(gong)(gong)(gong)(gong)(gong)示”的(de)栏(lan)目,公(gong)(gong)(gong)(gong)(gong)开(kai)(kai)(kai)了“拟(ni)突(tu)破性治疗(liao)品种(zhong)、异议(yi)论证结果”等信(xin)息(xi)(xi)(xi)(xi)(xi)。方便申(shen)(shen)请(qing)(qing)人(ren)(ren)查(cha)询信(xin)息(xi)(xi)(xi)(xi)(xi),进(jin)一步拓(tuo)宽了申(shen)(shen)请(qing)(qing)人(ren)(ren)的(de)沟通(tong)(tong)渠(qu)道,及时回应社会关切(qie),提高了审(shen)(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)(shen)批工(gong)作的(de)透(tou)明度(du)。

 十一、2021年重点工作安排

2020年(nian),药品审评(ping)(ping)(ping)工作(zuo)取得了一定进(jin)展(zhan),但仍存在着一些问题:一是注册申请(qing)申报量,特别是创(chuang)新(xin)药申报量连年(nian)递增(zeng),药审中(zhong)心审评(ping)(ping)(ping)队伍规(gui)模(mo)结构与审评(ping)(ping)(ping)任务量配(pei)比(bi)失(shi)衡;二是高层次及紧缺专业(ye)人才(cai)引进(jin)难、新(xin)进(jin)审评(ping)(ping)(ping)员急需长期专业(ye)培训等审评(ping)(ping)(ping)能力现代化(hua)短板问题突(tu)出;三是新(xin)旧注册相(xiang)(xiang)关规(gui)定过渡期间,应(ying)及时研究问题,给予相(xiang)(xiang)应(ying)的解决(jue)措施。2021年(nian)药审中(zhong)心将紧密围绕国家药监局工作(zuo)部署,重点(dian)开展(zhan)以下工作(zuo):

(一(yi))积极(ji)推动制(zhi)度体系建设

完(wan)善新(xin)《药品(pin)注册管(guan)理办(ban)法》配套文件,做(zuo)好新(xin)旧注册相关规定过渡期相关工作,稳(wen)妥(tuo)处理历史问题;继续(xu)开展药品(pin)审评(ping)(ping)流(liu)程(cheng)导(dao)向(xiang)科(ke)学管(guan)理体(ti)系建(jian)设(she)(she)工作,构建(jian)长效运行机制(zhi),完(wan)善药品(pin)技术指导(dao)原则体(ti)系,规范(fan)中(zhong)心制(zhi)度体(ti)系建(jian)设(she)(she),推动审评(ping)(ping)体(ti)系和审评(ping)(ping)能力现(xian)代化(hua)(hua);深入(ru)推进监管(guan)科(ke)学研(yan)究(jiu),深化(hua)(hua)与高(gao)校、科(ke)研(yan)院所合(he)作,加快首批重点项目研(yan)究(jiu)成果转化(hua)(hua)。

(二)毫不放松(song)做好应急审(shen)评审(shen)批工作

始(shi)终保持(chi)应急(ji)(ji)工作状态,完(wan)(wan)善研审(shen)(shen)联动机制,坚持(chi)特事特办,促进包括(kuo)中医(yi)药(yao)、抗体药(yao)物(wu)等新(xin)冠(guan)(guan)肺(fei)(fei)炎(yan)治(zhi)疗药(yao)物(wu)的(de)研发;持(chi)续做(zuo)好(hao)应急(ji)(ji)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)核查检验协调工作;继续强化服(fu)务指导,持(chi)续跟(gen)进各条技术路(lu)线新(xin)冠(guan)(guan)病(bing)毒(du)疫(yi)苗(miao)(miao)研发进展,依法依规严格审(shen)(shen)评(ping)(ping),继续做(zuo)好(hao)新(xin)冠(guan)(guan)肺(fei)(fei)炎(yan)治(zhi)疗药(yao)物(wu)和新(xin)冠(guan)(guan)病(bing)毒(du)疫(yi)苗(miao)(miao)审(shen)(shen)评(ping)(ping)工作;全(quan)面总(zong)结应急(ji)(ji)审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)工作经验,完(wan)(wan)善审(shen)(shen)评(ping)(ping)审(shen)(shen)批(pi)(pi)制度体系,进一(yi)步激发药(yao)品创新(xin)发展活(huo)力。

(三)加快建立(li)符合中医(yi)药(yao)特点的中药(yao)审评机制体系

构(gou)建中(zhong)医药(yao)理论、中(zhong)药(yao)人(ren)用(yong)经(jing)验(yan)和临(lin)床试验(yan)“三(san)结合”的(de)审(shen)(shen)(shen)评证(zheng)据(ju)体系,组建古代(dai)经(jing)典(dian)名方(fang)(fang)中(zhong)药(yao)复方(fang)(fang)制剂专(zhuan)家(jia)审(shen)(shen)(shen)评委员(yuan)会(hui),扎(zha)实推(tui)进中(zhong)药(yao)审(shen)(shen)(shen)评审(shen)(shen)(shen)批改革;参考“三(san)方(fang)(fang)”审(shen)(shen)(shen)评审(shen)(shen)(shen)批经(jing)验(yan),逐步(bu)探(tan)索(suo)适(shi)合古代(dai)经(jing)典(dian)名方(fang)(fang)的(de)中(zhong)药(yao)复方(fang)(fang)制剂的(de)审(shen)(shen)(shen)评指导原(yuan)则和标准,完善(shan)符合中(zhong)医药(yao)特点的(de)技术指导原(yuan)则;加(jia)快确(que)有临(lin)床价值的(de)中(zhong)药(yao)新药(yao)审(shen)(shen)(shen)批,发挥中(zhong)医药(yao)在疾病防(fang)治(zhi)中(zhong)的(de)独特优势。

(四)持续(xu)深化审(shen)评审(shen)批(pi)制度改革

巩(gong)固按时限审(shen)评改(gai)革(ge)成果,完善(shan)(shan)项(xiang)目管理工作机制(zhi);完善(shan)(shan)专家(jia)咨询委员会制(zhi)度(du)(du)(du),解决争(zheng)议重(zhong)大(da)(da)疑难问(wen)题,利用巡视整改(gai)要求推动制(zhi)度(du)(du)(du)改(gai)革(ge),加大(da)(da)审(shen)评审(shen)批信息公开(kai)力度(du)(du)(du),优化(hua)沟通交流制(zhi)度(du)(du)(du),提高审(shen)评服务水平(ping);细化(hua)上市药品变更管理技术要求,指导药品上市许可持(chi)有人开(kai)展上市后持(chi)续(xu)研(yan)究;进一(yi)步加强临(lin)床试验期间(jian)安全性评价及药物警戒体系建设(she);持(chi)续(xu)推进ICH指导原则在国内转化(hua)实施(shi);加快审(shen)评数字化(hua)建设(she),推进eCTD系统使用。加快推进研(yan)发生产(chan)主体信息库建设(she)。

(五)坚持鼓励药(yao)品(pin)研(yan)发创新

持(chi)续完善药(yao)品审(shen)(shen)评审(shen)(shen)批(pi)制度体系,坚持(chi)以安(an)全有效为根本标准,优(you)化审(shen)(shen)评资源配(pei)置,在创新药(yao)审(shen)(shen)评中(zhong)探(tan)索实施“提前(qian)(qian)介(jie)入”“研审(shen)(shen)联动”“平行检验”“前(qian)(qian)置检验”等方式;继续鼓励新药(yao)好药(yao)研发创新,强化沟通交流,优(you)先(xian)配(pei)置资源,进一(yi)步细化和(he)实施突破(po)性(xing)治疗药(yao)物、附条件批(pi)准、优(you)先(xian)审(shen)(shen)评、特别审(shen)(shen)批(pi)等加快(kuai)审(shen)(shen)评程(cheng)序(xu),加快(kuai)临(lin)床急需境外新药(yao)、罕见病(bing)用(yong)药(yao)、儿童用(yong)药(yao)、重大传染病(bing)用(yong)药(yao)等上市速(su)度。

(六)推动(dong)仿制药高质量发展

持续(xu)完(wan)善仿(fang)(fang)制药参比制剂遴选,坚持标(biao)准不降低的原(yuan)则(ze),稳(wen)妥有(you)序(xu)推(tui)进仿(fang)(fang)制药质量和(he)疗效一(yi)致性评(ping)价;进一(yi)步完(wan)善仿(fang)(fang)制药相关(guan)技术指导(dao)原(yuan)则(ze)和(he)标(biao)准体系建(jian)设;以建(jian)立审(shen)评(ping)要点体系为基础,推(tui)动仿(fang)(fang)制药审(shen)评(ping)科学规范、标(biao)准,提高仿(fang)(fang)制药审(shen)评(ping)质量和(he)效率。

(七(qi))优化人(ren)才队伍建设(she)

按照国家药监局统一(yi)(yi)部署(shu),全(quan)力指导和推进(jin)(jin)长三角、大湾(wan)区两个分中(zhong)心建(jian)设(she);以(yi)专(zhuan)业培(pei)训(xun)为抓手,进(jin)(jin)一(yi)(yi)步(bu)加(jia)强药品(pin)审评队(dui)伍(wu)能(neng)力建(jian)设(she);配合药品(pin)审评业务,积极开展(zhan)人员(yuan)招聘工作,加(jia)强队(dui)伍(wu)建(jian)设(she);进(jin)(jin)一(yi)(yi)步(bu)加(jia)强专(zhuan)业技术(shu)队(dui)伍(wu)建(jian)设(she),完善(shan)专(zhuan)业技术(shu)队(dui)伍(wu)晋(jin)升等制度(du);进(jin)(jin)一(yi)(yi)步(bu)严(yan)格人员(yuan)招聘条件,规范人员(yuan)离(li)职,严(yan)格队(dui)伍(wu)管理。

 十二、结(jie)语

大鹏一(yi)日同风(feng)起,扶摇直上九(jiu)万里(li)。2021年(nian)是实(shi)施“十(shi)四(si)(si)五”规划的开局之(zhi)年(nian),药审中(zhong)心将在(zai)国(guo)家药监局的坚(jian)强领导下,坚(jian)持以(yi)(yi)习近平新(xin)时代中(zhong)国(guo)特(te)色社(she)会主(zhu)义(yi)思想(xiang)为指导,全面贯彻(che)党的十(shi)九(jiu)大和十(shi)九(jiu)届(jie)二(er)中(zhong)、三中(zhong)、四(si)(si)中(zhong)、五中(zhong)全会精神,坚(jian)持以(yi)(yi)人(ren)民为中(zhong)心的发(fa)(fa)展(zhan)思想(xiang),按照立(li)足新(xin)发(fa)(fa)展(zhan)阶(jie)段(duan),贯彻(che)新(xin)发(fa)(fa)展(zhan)理念,构(gou)建(jian)新(xin)发(fa)(fa)展(zhan)格局的要求(qiu),以(yi)(yi)习近平总书(shu)记“四(si)(si)个最(zui)严”要求(qiu)为根(gen)本遵循,以(yi)(yi)鼓励创新(xin)推动(dong)药品(pin)高质量发(fa)(fa)展(zhan)为主(zhu)题,以(yi)(yi)深化药品(pin)审评审批(pi)制(zhi)度改革为主(zhu)线,以(yi)(yi)满足人(ren)民日益增长(zhang)的美好(hao)(hao)(hao)生活(huo)需要为根(gen)本目的,以(yi)(yi)建(jian)设(she)国(guo)际化现代化科学化药品(pin)审评机构(gou)为根(gen)本动(dong)力,坚(jian)持为国(guo)为民履职(zhi)尽责,切(qie)实(shi)保障药品(pin)安全有效可及,保护(hu)和促进公众(zhong)健康,努力实(shi)现“十(shi)四(si)(si)五”时期(qi)发(fa)(fa)展(zhan)开好(hao)(hao)(hao)局、起好(hao)(hao)(hao)步,以(yi)(yi)优异(yi)成(cheng)绩迎(ying)接中(zhong)国(guo)共产党成(cheng)立(li)100周(zhou)年(nian)。

 

 

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来源:国家药品监督(du)管(guan)理局网站,具体详见:http://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20210621142436183.html