2020年度药品审评报告

时间:2020-06-22

2020年是极(ji)不平(ping)凡(fan)的(de)一年,面对(dui)突(tu)如其(qi)来的(de)新(xin)(xin)冠肺(fei)炎(yan)疫(yi)(yi)情,国家药(yao)品(pin)监(jian)督管(guan)(guan)(guan)理(li)(li)局(ju)药(yao)品(pin)审(shen)(shen)(shen)(shen)评(ping)中(zhong)心(xin)(以下简称(cheng)药(yao)审(shen)(shen)(shen)(shen)中(zhong)心(xin))在国家药(yao)品(pin)监(jian)督管(guan)(guan)(guan)理(li)(li)局(ju)(以下简称(cheng)国家药(yao)监(jian)局(ju))的(de)坚强(qiang)领导下,认(ren)真学习(xi)贯(guan)彻习(xi)近平(ping)总(zong)书记重要讲话和(he)(he)重要指示批(pi)示精神,闻令(ling)而动、尽锐(rui)出战,坚持人(ren)民(min)至(zhi)上、生(sheng)命(ming)至(zhi)上,超常规建(jian)立“早期介(jie)入、持续跟踪、主(zhu)动服(fu)务、研审(shen)(shen)(shen)(shen)联动”全天候(hou)应急审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)工(gong)(gong)(gong)作机制,加(jia)速推动新(xin)(xin)冠病毒疫(yi)(yi)苗和(he)(he)新(xin)(xin)冠肺(fei)炎(yan)治疗药(yao)物(wu)研发(fa)上市,充分(fen)发(fa)挥技(ji)术审(shen)(shen)(shen)(shen)评(ping)对(dui)疫(yi)(yi)情防(fang)(fang)控(kong)的(de)科技(ji)支撑作用(yong);主(zhu)动服(fu)务于药(yao)监(jian)系统工(gong)(gong)(gong)作大局(ju),紧紧围(wei)绕落实党(dang)中(zhong)央国务院审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)制度改革、贯(guan)彻《药(yao)品(pin)管(guan)(guan)(guan)理(li)(li)法》《疫(yi)(yi)苗管(guan)(guan)(guan)理(li)(li)法》《药(yao)品(pin)注册(ce)管(guan)(guan)(guan)理(li)(li)办(ban)法》、推动审(shen)(shen)(shen)(shen)评(ping)体(ti)系和(he)(he)审(shen)(shen)(shen)(shen)评(ping)能力现代化(hua),统筹推进疫(yi)(yi)情防(fang)(fang)控(kong)和(he)(he)依(yi)(yi)法依(yi)(yi)规科学审(shen)(shen)(shen)(shen)评(ping)工(gong)(gong)(gong)作,不断提高审(shen)(shen)(shen)(shen)评(ping)质量和(he)(he)效率,不断加(jia)快新(xin)(xin)药(yao)研发(fa)上市步伐,为疫(yi)(yi)情防(fang)(fang)控(kong)和(he)(he)满足临床(chuang)急需提供有(you)效药(yao)物(wu)保障、为医药(yao)产业高质量发(fa)展提供有(you)力促进作用(yong),保障了人(ren)民(min)群众用(yong)药(yao)安全有(you)效可及(ji),药(yao)品(pin)审(shen)(shen)(shen)(shen)评(ping)事业得到(dao)新(xin)(xin)发(fa)展、迈上新(xin)(xin)台阶、开创新(xin)(xin)局(ju)面。 

一、药品注册申请(qing)审评审批情况

(一)总体(ti)完成(cheng)情况(kuang)

1.全年审评审批完成情况

2020年,根据《药(yao)品注(zhu)(zhu)册(ce)(ce)(ce)(ce)管理(li)办(ban)(ban)法》(国家(jia)市(shi)场监督(du)管理(li)总(zong)局(ju)令第(di)27号(hao))、《国家(jia)药(yao)监局(ju)关于实施(shi)<药(yao)品注(zhu)(zhu)册(ce)(ce)(ce)(ce)管理(li)办(ban)(ban)法>有关事宜的(de)公告》(2020年第(di)46号(hao),以(yi)下简称46号(hao)公告)及《药(yao)品注(zhu)(zhu)册(ce)(ce)(ce)(ce)管理(li)办(ban)(ban)法》相(xiang)关配(pei)套文件(jian),药(yao)审(shen)中心完(wan)成中药(yao)(包(bao)括民族药(yao),下同(tong))、化学药(yao)、生物(wu)制品各类注(zhu)(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)请审(shen)评(ping)审(shen)批(pi)共(gong)11582件(jian)(含器械组合产品4件(jian),以(yi)受理(li)号(hao)计(ji),下同(tong)),较(jiao)2019年增长(zhang)32.67%(如无(wu)说明(ming),以(yi)注(zhu)(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)请件(jian)数计(ji),下同(tong))。其中,完(wan)成需(xu)技(ji)(ji)(ji)术审(shen)评(ping)的(de)注(zhu)(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)请8606件(jian)(含5674件(jian)需(xu)药(yao)审(shen)中心技(ji)(ji)(ji)术审(shen)评(ping)和行政(zheng)审(shen)批(pi)注(zhu)(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)请),较(jiao)2019年增长(zhang)26.24%;完(wan)成直接行政(zheng)审(shen)批(pi)(无(wu)需(xu)技(ji)(ji)(ji)术审(shen)评(ping),下同(tong))的(de)注(zhu)(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)请2972件(jian)。2020年底(di)正在审(shen)评(ping)审(shen)批(pi)和等待审(shen)评(ping)审(shen)批(pi)的(de)注(zhu)(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)请已由(you)2015年9月高(gao)峰时的(de)近22000件(jian)降至4882件(jian)(不含完(wan)成技(ji)(ji)(ji)术审(shen)评(ping)因申(shen)(shen)报资(zi)料缺陷等待申(shen)(shen)请人回复(fu)补充资(zi)料的(de)注(zhu)(zhu)册(ce)(ce)(ce)(ce)申(shen)(shen)请)。

完成(cheng)8606件需技(ji)术审评(ping)的药品注(zhu)(zhu)册申(shen)(shen)请(qing)(qing)中,化学(xue)药注(zhu)(zhu)册申(shen)(shen)请(qing)(qing)为6778件,较2019年(nian)增(zeng)(zeng)长25.22%;中药注(zhu)(zhu)册申(shen)(shen)请(qing)(qing)418件,较2019年(nian)增(zeng)(zeng)长39.33%;生(sheng)物制(zhi)品注(zhu)(zhu)册申(shen)(shen)请(qing)(qing)1410件,较2019年(nian)增(zeng)(zeng)长27.72%;化学(xue)药注(zhu)(zhu)册申(shen)(shen)请(qing)(qing)约(yue)占全部技(ji)术审评(ping)完成(cheng)量(liang)的78.76%。2016-2020年(nian)中药、生(sheng)物制(zhi)品、化学(xue)药注(zhu)(zhu)册申(shen)(shen)请(qing)(qing)审评(ping)审批(pi)完成(cheng)情况详见图1。

 

 

  药审(shen)(shen)(shen)中心完(wan)成(cheng)(cheng)需(xu)技术审(shen)(shen)(shen)评(ping)(ping)的8606件(jian)注册申(shen)(shen)(shen)请(qing)中,完(wan)成(cheng)(cheng)新药临床试验(IND)申(shen)(shen)(shen)请(qing)审(shen)(shen)(shen)评(ping)(ping)1561件(jian),较(jiao)2019年(nian)增长(zhang)55.94%;完(wan)成(cheng)(cheng)新药上市申(shen)(shen)(shen)请(qing)(NDA)审(shen)(shen)(shen)评(ping)(ping)289件(jian),完(wan)成(cheng)(cheng)仿制药上市申(shen)(shen)(shen)请(qing)(ANDA)审(shen)(shen)(shen)评(ping)(ping)1700件(jian);完(wan)成(cheng)(cheng)仿制药质(zhi)量(liang)和疗效一(yi)致(zhi)性评(ping)(ping)价(以下简(jian)称(cheng)一(yi)致(zhi)性评(ping)(ping)价)申(shen)(shen)(shen)请(qing)(以补充申(shen)(shen)(shen)请(qing)途(tu)径申(shen)(shen)(shen)报(bao))1136件(jian),较(jiao)2019年(nian)增长(zhang)103.22%;完(wan)成(cheng)(cheng)补充申(shen)(shen)(shen)请(qing)技术审(shen)(shen)(shen)评(ping)(ping)3250件(jian),较(jiao)2019年(nian)增长(zhang)24.19%。2016-2020年(nian)各(ge)类注册申(shen)(shen)(shen)请(qing)审(shen)(shen)(shen)评(ping)(ping)完(wan)成(cheng)(cheng)情况详见图(tu)2。

 

3.审评通过情况

2020年(nian),药审(shen)(shen)中心(xin)审(shen)(shen)评通过(guo)批准(zhun)IND申请1435件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长54.97%;审(shen)(shen)评通过(guo)NDA 208件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长26.83%;审(shen)(shen)评通过(guo)ANDA 918件(jian);审(shen)(shen)评通过(guo)批准(zhun)一(yi)致(zhi)性评价申请577件(jian),较(jiao)2019年(nian)增(zeng)(zeng)长121.92%。

药审(shen)中心审(shen)评通过创(chuang)新药NDA 20个(ge)品(pin)(pin)(pin)种(zhong),审(shen)评通过境外(wai)生产(chan)原研药品(pin)(pin)(pin)NDA 72个(ge)品(pin)(pin)(pin)种(zhong)(含新增(zeng)适应症品(pin)(pin)(pin)种(zhong)),具(ju)体品(pin)(pin)(pin)种(zhong)详见(jian)附件1、2。

4.审结(jie)注册申请任(ren)务按时(shi)限完成(cheng)情(qing)况

2020年,药审(shen)(shen)(shen)(shen)中(zhong)心持续优(you)化审(shen)(shen)(shen)(shen)评(ping)(ping)流程,严格审(shen)(shen)(shen)(shen)评(ping)(ping)时限管(guan)理(li),加(jia)强项目督导,加(jia)快审(shen)(shen)(shen)(shen)评(ping)(ping)速度,整(zheng)体审(shen)(shen)(shen)(shen)评(ping)(ping)任(ren)(ren)(ren)务(wu)(wu)和重(zhong)点序列(lie)审(shen)(shen)(shen)(shen)评(ping)(ping)任(ren)(ren)(ren)务(wu)(wu)按时限完(wan)(wan)成(cheng)率(lv)均取得显著提升(sheng)。全年审(shen)(shen)(shen)(shen)结注(zhu)册申请(qing)任(ren)(ren)(ren)务(wu)(wu)整(zheng)体按时限完(wan)(wan)成(cheng)率(lv)为(wei)94.48%,其中(zhong)临床急需(xu)境(jing)外(wai)已上市新药注(zhu)册申请(qing)审(shen)(shen)(shen)(shen)结任(ren)(ren)(ren)务(wu)(wu)整(zheng)体按时限完(wan)(wan)成(cheng)率(lv)为(wei)100%,按默示许可受(shou)理(li)注(zhu)册申请(qing)的审(shen)(shen)(shen)(shen)结任(ren)(ren)(ren)务(wu)(wu)整(zheng)体按时限完(wan)(wan)成(cheng)率(lv)为(wei)99.87%,直接行政审(shen)(shen)(shen)(shen)批的注(zhu)册申请(qing)100%在法定的20个(ge)工(gong)作日内完(wan)(wan)成(cheng),且审(shen)(shen)(shen)(shen)批平均用(yong)时11.8个(ge)工(gong)作日。各类(lei)注(zhu)册申请(qing)任(ren)(ren)(ren)务(wu)(wu)按时限完(wan)(wan)成(cheng)情(qing)况(kuang)详见表1。

 

  2020年(nian)(nian)的(de)NDA年(nian)(nian)度整体(ti)按(an)(an)时限(xian)(xian)完成(cheng)率(lv)已经有了很大的(de)提升(sheng),例(li)如(ru):NDA按(an)(an)时限(xian)(xian)完成(cheng)率(lv)在2020年(nian)(nian)12月突破80%,提升(sheng)至87.5%;ANDA按(an)(an)时限(xian)(xian)完成(cheng)率(lv)在2020年(nian)(nian)12月突破90%,达到93.85%;纳入优(you)先(xian)审评程(cheng)序的(de)注(zhu)册申请(qing)按(an)(an)时限(xian)(xian)完成(cheng)率(lv)在2020年(nian)(nian)10-12月的(de)月度按(an)(an)时限(xian)(xian)完成(cheng)率(lv)连续达到90%以上,取得历史(shi)性突破。

(二)中药(yao)注册(ce)申请审(shen)评完成情况

1.总(zong)体情况

2020年(nian),药审(shen)中(zhong)心(xin)完(wan)(wan)成(cheng)审(shen)评的中(zhong)药注(zhu)册申(shen)请(qing)418件。其中(zhong),完(wan)(wan)成(cheng)IND申(shen)请(qing)37件,完(wan)(wan)成(cheng)NDA 8件,完(wan)(wan)成(cheng)ANDA 3件。2020年(nian)中(zhong)药各类(lei)注(zhu)册申(shen)请(qing)的审(shen)评完(wan)(wan)成(cheng)情况详见图3。

 

2.审评通过情(qing)况

药(yao)(yao)(yao)审(shen)中(zhong)(zhong)心审(shen)评通(tong)过(guo)(guo)批(pi)准中(zhong)(zhong)药(yao)(yao)(yao)IND申请28件,审(shen)评通(tong)过(guo)(guo)中(zhong)(zhong)药(yao)(yao)(yao)NDA 4件(连花清(qing)咳片、筋骨止痛凝胶、桑枝(zhi)总生物(wu)碱(jian)片及桑枝(zhi)总生物(wu)碱(jian))。2020年中(zhong)(zhong)药(yao)(yao)(yao)各类注(zhu)册申请审(shen)评完成的具体情况详(xiang)见表2,2016-2020年审(shen)评通(tong)过(guo)(guo)批(pi)准中(zhong)(zhong)药(yao)(yao)(yao)IND申请和(he)审(shen)评通(tong)过(guo)(guo)中(zhong)(zhong)药(yao)(yao)(yao)NDA情况详(xiang)见图4。

 

 

  药(yao)审(shen)中心审(shen)评(ping)通(tong)过批准的中药(yao)IND申(shen)请28件(jian)(jian),涉及10个适应症(zheng)领(ling)域。其中,呼(hu)吸7件(jian)(jian)、骨科4件(jian)(jian)、消化(hua)4件(jian)(jian),共占53.57%,2020年审(shen)评(ping)通(tong)过批准的中药(yao)IND申(shen)请适应症(zheng)分布详(xiang)见图(tu)5。

 

(三)化学药注册(ce)申请审评完成(cheng)情况

1.总体情况

2020年(nian),药(yao)(yao)(yao)审(shen)中心完(wan)(wan)成(cheng)审(shen)评的化(hua)(hua)学(xue)(xue)(xue)药(yao)(yao)(yao)注册申请6778件(jian)(jian)。其中,完(wan)(wan)成(cheng)化(hua)(hua)学(xue)(xue)(xue)药(yao)(yao)(yao)临床申请(IND申请和(he)验(yan)证性临床)共1086件(jian)(jian),较(jiao)(jiao)2019年(nian)增长(zhang)45.58%;完(wan)(wan)成(cheng)化(hua)(hua)学(xue)(xue)(xue)药(yao)(yao)(yao)NDA 163件(jian)(jian);完(wan)(wan)成(cheng)化(hua)(hua)学(xue)(xue)(xue)药(yao)(yao)(yao)ANDA 1697件(jian)(jian);完(wan)(wan)成(cheng)一致性评价申请1136件(jian)(jian),较(jiao)(jiao)2019年(nian)增长(zhang)103.22%;完(wan)(wan)成(cheng)化(hua)(hua)学(xue)(xue)(xue)药(yao)(yao)(yao)补充申请2248件(jian)(jian),较(jiao)(jiao)2019年(nian)增长(zhang)23.72%。2020年(nian)化(hua)(hua)学(xue)(xue)(xue)药(yao)(yao)(yao)各(ge)类(lei)注册申请的审(shen)评完(wan)(wan)成(cheng)情(qing)况详见图6。

 

2.审评(ping)通(tong)过情况

药(yao)审(shen)中心完成审(shen)评(ping)的化(hua)学药(yao)注册(ce)申(shen)请(qing)中,审(shen)评(ping)通过(guo)批(pi)准IND申(shen)请(qing)907件(jian),较2019年(nian)增长(zhang)51.42%;审(shen)评(ping)通过(guo)NDA 115件(jian),较2019年(nian)增长(zhang)30.68%;审(shen)评(ping)通过(guo)ANDA 918件(jian),较2019年(nian)增长(zhang)15.33%。2020年(nian)化(hua)学药(yao)各(ge)类注册(ce)申(shen)请(qing)审(shen)评(ping)完成的具体(ti)情况详见表(biao)3。

 

药(yao)审中(zhong)心(xin)完成审评(ping)的化(hua)学药(yao)IND申(shen)(shen)请(qing)960件(jian),审评(ping)通过批(pi)准(zhun)IND申(shen)(shen)请(qing)907件(jian)。其中(zhong),1类创(chuang)新化(hua)学药(yao)IND申(shen)(shen)请(qing)694件(jian)(298个品(pin)种(zhong)),较(jiao)(jiao)2019年增(zeng)长(zhang)40.77%,品(pin)种(zhong)数(shu)较(jiao)(jiao)2019年增(zeng)长(zhang)57.67%。2016-2020年审评(ping)通过批(pi)准(zhun)化(hua)学药(yao)IND申(shen)(shen)请(qing)、1类创(chuang)新化(hua)学药(yao)IND申(shen)(shen)请(qing)情况详(xiang)见(jian)图(tu)7。

 

药审中(zhong)心审评通(tong)过批准(zhun)(zhun)IND申请的(de)(de)694件1类创(chuang)新(xin)化(hua)(hua)学(xue)药中(zhong),抗肿瘤药物(wu)(wu)、抗感(gan)染药物(wu)(wu)、循环系统疾(ji)(ji)病(bing)药物(wu)(wu)、内分泌系统药物(wu)(wu)、消化(hua)(hua)系统疾(ji)(ji)病(bing)药物(wu)(wu)和风(feng)湿(shi)性(xing)疾(ji)(ji)病(bing)及免疫药物(wu)(wu)较多,占全部(bu)创(chuang)新(xin)药临(lin)床试验(yan)批准(zhun)(zhun)数量的(de)(de)80.69%。2020年审评通(tong)过批准(zhun)(zhun)的(de)(de)1类创(chuang)新(xin)化(hua)(hua)学(xue)药IND申请适应症(zheng)分布详见(jian)图8。

 

药(yao)(yao)审(shen)(shen)中心(xin)完(wan)成审(shen)(shen)评(ping)的化(hua)学(xue)药(yao)(yao)NDA共(gong)163件(jian)。其中,审(shen)(shen)评(ping)通过化(hua)药(yao)(yao)NDA 115件(jian),审(shen)(shen)评(ping)通过1类创新化(hua)学(xue)药(yao)(yao)NDA 14个品种。2016-2020年审(shen)(shen)评(ping)通过化(hua)学(xue)药(yao)(yao)NDA情况(kuang)详见图9。

 

  药审中心完成审评(ping)的一致性评(ping)价(jia)申请共1136件(jian),审评(ping)通(tong)过577件(jian)。其中,审评(ping)通(tong)过批(pi)准口服固(gu)体制剂一致性评(ping)价(jia)456件(jian),审评(ping)通(tong)过批(pi)准注射剂一致性评(ping)价(jia)申请121件(jian),具体品种详见(jian)附件(jian)3。2018-2020年审评(ping)通(tong)过批(pi)准的一致性评(ping)价(jia)申请情况详见(jian)图10。

 

(四)生物制品(pin)注册申请审评完(wan)成情况

1.总体情况

2020年(nian),药审中心(xin)完成(cheng)审评的生(sheng)(sheng)物(wu)(wu)制品注册申(shen)请(qing)(qing)共1410件。其中,完成(cheng)预(yu)防(fang)用(yong)(yong)生(sheng)(sheng)物(wu)(wu)制品IND申(shen)请(qing)(qing)(预(yu)防(fang)用(yong)(yong)IND申(shen)请(qing)(qing))27件,完成(cheng)治(zhi)疗用(yong)(yong)生(sheng)(sheng)物(wu)(wu)制品IND申(shen)请(qing)(qing)(治(zhi)疗用(yong)(yong)IND申(shen)请(qing)(qing))537件,较(jiao)2019年(nian)增长58.88%;完成(cheng)预(yu)防(fang)用(yong)(yong)生(sheng)(sheng)物(wu)(wu)制品NDA(预(yu)防(fang)用(yong)(yong)NDA)9件,完成(cheng)治(zhi)疗用(yong)(yong)生(sheng)(sheng)物(wu)(wu)制品NDA(治(zhi)疗用(yong)(yong)NDA)108件,完成(cheng)体(ti)外(wai)诊断(duan)试剂(ji)NDA(体(ti)外(wai)诊断(duan)NDA)1件。2020年(nian)生(sheng)(sheng)物(wu)(wu)制品各类(lei)注册申(shen)请(qing)(qing)的审评完成(cheng)情(qing)况详(xiang)见(jian)图11。

 

2.审(shen)评通过情况

药审(shen)(shen)(shen)(shen)中心(xin)审(shen)(shen)(shen)(shen)评通过批准生(sheng)物制(zhi)(zhi)品IND申(shen)(shen)请(qing)500件(jian),较(jiao)2019年(nian)(nian)增长60.26%。其中,预(yu)防用IND申(shen)(shen)请(qing)19件(jian);治疗用IND申(shen)(shen)请(qing)481件(jian),较(jiao)2019年(nian)(nian)增长63.61%。审(shen)(shen)(shen)(shen)评通过生(sheng)物制(zhi)(zhi)品NDA 89件(jian),较(jiao)2019年(nian)(nian)增长20.27%。其中,预(yu)防用NDA 7件(jian);治疗用NDA 81件(jian)(制(zhi)(zhi)剂77件(jian)),较(jiao)2019年(nian)(nian)增长19.12%;体外诊断NDA 1件(jian)。2020年(nian)(nian)生(sheng)物制(zhi)(zhi)品各类注册(ce)申(shen)(shen)请(qing)审(shen)(shen)(shen)(shen)评完成的(de)具体情况(kuang)详(xiang)见(jian)表4,2016-2020年(nian)(nian)审(shen)(shen)(shen)(shen)评通过批准生(sheng)物制(zhi)(zhi)品IND申(shen)(shen)请(qing)和审(shen)(shen)(shen)(shen)评通过NDA情况(kuang)详(xiang)见(jian)图(tu)12。

 

 

药(yao)审(shen)中心(xin)审(shen)评(ping)通过批准(zhun)生物制(zhi)品(pin)IND申请500件,2020年审(shen)评(ping)通过批准(zhun)的生物制(zhi)品(pin)IND申请适应症分(fen)布详见图13。药(yao)审(shen)中心(xin)审(shen)评(ping)通过生物制(zhi)品(pin)NDA 89件,2020年审(shen)评(ping)通过的生物制(zhi)品(pin)NDA适应症分(fen)布详见图14。

 

 

(五)行(xing)政(zheng)审批注册申请完成情(qing)况

1.总体情况

2020年(nian),药(yao)审中(zhong)心完(wan)(wan)成(cheng)中(zhong)药(yao)、化学(xue)(xue)药(yao)、生(sheng)(sheng)物(wu)制品各类(lei)注(zhu)册(ce)申(shen)请行(xing)政(zheng)审批(pi)(pi)共8646件,较(jiao)2019年(nian)增长44.51%。其中(zhong),完(wan)(wan)成(cheng)审评(ping)(ping)审批(pi)(pi)的(de)(de)注(zhu)册(ce)申(shen)请(临床试验申(shen)请、一致性(xing)评(ping)(ping)价申(shen)请、补(bu)充(chong)申(shen)请、境外生(sheng)(sheng)产药(yao)品再注(zhu)册(ce)及复审)5674件,较(jiao)2019年(nian)增长39.24%;完(wan)(wan)成(cheng)直接行(xing)政(zheng)审批(pi)(pi)的(de)(de)注(zhu)册(ce)申(shen)请(无(wu)需技术审评(ping)(ping)的(de)(de)补(bu)充(chong)申(shen)请、临时进口申(shen)请)2972件,较(jiao)2019年(nian)增长55.77%。2020年(nian)中(zhong)药(yao)、化学(xue)(xue)药(yao)、生(sheng)(sheng)物(wu)制品各类(lei)注(zhu)册(ce)申(shen)请行(xing)政(zheng)审批(pi)(pi)完(wan)(wan)成(cheng)情况见表(biao)5。2018-2020年(nian)行(xing)政(zheng)审批(pi)(pi)注(zhu)册(ce)申(shen)请完(wan)(wan)成(cheng)情况详(xiang)见图15。

 

 

2.需(xu)审(shen)评审(shen)批的注册申请完成情况(kuang)

药审(shen)(shen)中心(xin)完成的需审(shen)(shen)评审(shen)(shen)批的5674件(jian)(jian)注册(ce)申(shen)请中,临床试验(yan)申(shen)请1686件(jian)(jian)(含验(yan)证性(xing)临床),较2019年增(zeng)长(zhang)(zhang)50.00%;一(yi)致性(xing)评价(jia)申(shen)请623件(jian)(jian),较2019年增(zeng)长(zhang)(zhang)80.58%;补充申(shen)请2860件(jian)(jian),较2019年增(zeng)长(zhang)(zhang)34.46%;境外生产药品再注册(ce)478件(jian)(jian)、复审(shen)(shen)27件(jian)(jian)。

3.直接行(xing)政审批的注册(ce)申请完成(cheng)情况

药审中(zhong)心完成直接行(xing)政审批(pi)的2972件(jian)注册申(shen)(shen)(shen)请(qing)中(zhong),按注册申(shen)(shen)(shen)请(qing)类(lei)型(xing)划分(fen),补充申(shen)(shen)(shen)请(qing)2537件(jian)、临时进(jin)口申(shen)(shen)(shen)请(qing)435件(jian)。按药品(pin)(pin)类(lei)型(xing)划分(fen),中(zhong)药153件(jian)、化学药2411件(jian)、生物制品(pin)(pin)408件(jian)。

(六)注册申请不批(pi)准(zhun)的主要原因(yin)及存在的问题

2020年(nian),中药(yao)(yao)、化(hua)学药(yao)(yao)、生物制品(pin)各类(lei)药(yao)(yao)品(pin)注(zhu)册申请(qing)因(yin)申报(bao)资料无法证明药(yao)(yao)品(pin)安(an)全(quan)性(xing)、有效性(xing)或者质量可控性(xing),以及未能(neng)按期(qi)提(ti)交补充资料等(deng)情形(xing),导致(zhi)审评结论为建议不(bu)(bu)批准(zhun)的共367件(jian)。通(tong)过系(xi)统(tong)梳(shu)理上(shang)述注(zhu)册申请(qing)不(bu)(bu)批准(zhun)原因(yin),从新(xin)药(yao)(yao)、仿制药(yao)(yao)等(deng)不(bu)(bu)同注(zhu)册分类(lei)角(jiao)度(du)分析药(yao)(yao)品(pin)注(zhu)册申请(qing)在研发(fa)和(he)申报(bao)过程中存在的主要(yao)问题包括:

1.新(xin)药申请

IND申请和(he)(he)研(yan)(yan)发中存在的(de)(de)(de)问题主要有(you):正式申报前未开(kai)展沟(gou)通交流;开(kai)发立题依据(ju)(ju)不(bu)(bu)足(zu),成药(yao)(yao)性存在严(yan)(yan)(yan)重(zhong)缺陷;申报资料不(bu)(bu)足(zu)以支持开(kai)展药(yao)(yao)物临(lin)(lin)(lin)床试(shi)(shi)验或(huo)者(zhe)不(bu)(bu)能保障临(lin)(lin)(lin)床受试(shi)(shi)者(zhe)安全(quan)。具体表现(xian)(xian)包括:未沟(gou)通交流致使申报后发现(xian)(xian)研(yan)(yan)究信息(xi)严(yan)(yan)(yan)重(zhong)缺项,无(wu)法在时限内完成补充研(yan)(yan)究;已有(you)的(de)(de)(de)研(yan)(yan)究结果提(ti)示药(yao)(yao)效作用(yong)弱,毒性大,临(lin)(lin)(lin)床获益和(he)(he)风(feng)险比值不(bu)(bu)合理;临(lin)(lin)(lin)床开(kai)发定(ding)位违背临(lin)(lin)(lin)床诊疗、用(yong)药(yao)(yao)的(de)(de)(de)基本原则(ze);已有(you)的(de)(de)(de)药(yao)(yao)学、临(lin)(lin)(lin)床前研(yan)(yan)究不(bu)(bu)符合临(lin)(lin)(lin)床试(shi)(shi)验要求;临(lin)(lin)(lin)床试(shi)(shi)验方案(an)整体设计严(yan)(yan)(yan)重(zhong)缺陷,风(feng)险控制措施不(bu)(bu)足(zu);联合用(yong)药(yao)(yao)的(de)(de)(de)非临(lin)(lin)(lin)床研(yan)(yan)究数据(ju)(ju)不(bu)(bu)充分(fen);联合疫苗(miao)中单(dan)苗(miao)的(de)(de)(de)数据(ju)(ju)不(bu)(bu)充分(fen)和(he)(he)/或(huo)免疫程序不(bu)(bu)一致。

NDA研发和(he)申(shen)报(bao)中(zhong)存在(zai)的(de)问题主要(yao)有(you):研究(jiu)质量(liang)控(kong)制和(he)管理(li)存在(zai)缺(que)陷,导致(zhi)已有(you)的(de)研究(jiu)结(jie)果不能证明(ming)药品安全性、有(you)效(xiao)性和(he)质量(liang)可控(kong)性;违反合规(gui)性要(yao)求。具(ju)体表现包括:关(guan)键临床研究(jiu)设(she)计(ji)存在(zai)重大缺(que)陷,无(wu)法得出(chu)客观(guan)、有(you)力的(de)有(you)效(xiao)性、安全性证据;药学研究(jiu)存在(zai)严重缺(que)陷,无(wu)法证明(ming)产品的(de)质量(liang)可控(kong)性;各开发阶段的(de)研究(jiu)受试样品不一致(zhi);注册核查中(zhong)发现临床试验数据存在(zai)真(zhen)实(shi)性问题。

2.仿(fang)制药申请

仿(fang)(fang)制(zhi)(zhi)(zhi)药(yao)(yao)一(yi)致(zhi)性评价申(shen)请和上(shang)市申(shen)请中存在(zai)的(de)(de)问题主要有:仿(fang)(fang)制(zhi)(zhi)(zhi)药(yao)(yao)研(yan)发(fa)立题不合(he)(he)理;申(shen)报资料无(wu)法(fa)证明仿(fang)(fang)制(zhi)(zhi)(zhi)药(yao)(yao)与(yu)参比(bi)制(zhi)(zhi)(zhi)剂(被(bei)仿(fang)(fang)制(zhi)(zhi)(zhi)药(yao)(yao)品(pin))的(de)(de)质量一(yi)致(zhi)性。具(ju)体(ti)表现(xian)包括:仿(fang)(fang)制(zhi)(zhi)(zhi)药(yao)(yao)的(de)(de)参比(bi)制(zhi)(zhi)(zhi)剂已撤市,且(qie)已有更新换代(dai)安(an)全性更好(hao)的(de)(de)产(chan)品(pin)满(man)足临床需求;样品(pin)复核检验(yan)(yan)不符合(he)(he)规定或分析方法(fa)存在(zai)严重(zhong)缺(que)陷;人体(ti)生物等效性试验(yan)(yan)结果表明不等效;样品(pin)稳定性研(yan)究结果、原料药(yao)(yao)起(qi)始物料选择等不符合(he)(he)仿(fang)(fang)制(zhi)(zhi)(zhi)药(yao)(yao)上(shang)市技术(shu)要求;仿(fang)(fang)制(zhi)(zhi)(zhi)药(yao)(yao)未按规定使用(yong)具(ju)有合(he)(he)法(fa)来源的(de)(de)原料药(yao)(yao)。

3.补(bu)充申请

补(bu)充申(shen)(shen)请研(yan)(yan)究(jiu)和申(shen)(shen)报中存在的问(wen)题主(zhu)要有:申(shen)(shen)请资料(liao)未能(neng)充分(fen)说(shuo)明变(bian)更(geng)(geng)的科学性(xing)(xing)和合理性(xing)(xing),不(bu)足以支持(chi)变(bian)更(geng)(geng)事(shi)项;已(yi)有的研(yan)(yan)究(jiu)结果(guo)不(bu)能(neng)保证变(bian)更(geng)(geng)后产(chan)品(pin)的安(an)(an)全性(xing)(xing)、有效(xiao)性(xing)(xing)和质量(liang)可控性(xing)(xing)。具体表(biao)现包括:变(bian)更(geng)(geng)引(yin)起药用物质基础发生重(zhong)大改变(bian);药品(pin)说(shuo)明书修改申(shen)(shen)请不(bu)符合说(shuo)明书撰(zhuan)写的技术要求;用于支持(chi)变(bian)更(geng)(geng)的文献资料(liao)存在偏倚,或者临(lin)床安(an)(an)全性(xing)(xing)和有效(xiao)性(xing)(xing)数(shu)据不(bu)充分(fen)。

4.其他(ta)

其他(ta)药(yao)(yao)品(pin)注册申请在研发(fa)和申报中存在的问题主(zhu)要有:生(sheng)物类似(si)药(yao)(yao)开发(fa)缺少相似(si)性比较数据,药(yao)(yao)学比对研究中参照药(yao)(yao)选择存在缺陷(xian);生(sheng)物类似(si)药(yao)(yao)临床(chuang)前研究结(jie)果不(bu)足(zu)以(yi)支(zhi)持其开展临床(chuang)试验;天然(ran)药(yao)(yao)物的研究资(zi)料(liao)不(bu)符合国际多中心临床(chuang)试验或我国天然(ran)药(yao)(yao)物评价(jia)基本技术要求。

(七)药品加(jia)快上市注册程序情况

创新(xin)是推(tui)动药(yao)(yao)(yao)(yao)(yao)品(pin)高质量发展(zhan)(zhan)的(de)力量源泉(quan),《药(yao)(yao)(yao)(yao)(yao)品(pin)注(zhu)册管理办法》结合我国(guo)医药(yao)(yao)(yao)(yao)(yao)产业(ye)发展(zhan)(zhan)和(he)临(lin)床(chuang)需(xu)(xu)(xu)求实际,参考国(guo)际经验,设(she)立(li)了特别审(shen)批、突(tu)破性(xing)治(zhi)(zhi)疗(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)、附条件(jian)批准、优先(xian)审(shen)评(ping)(ping)审(shen)批四个(ge)药(yao)(yao)(yao)(yao)(yao)品(pin)加快(kuai)(kuai)上(shang)市(shi)(shi)程(cheng)序(xu)(xu)。《国(guo)家药(yao)(yao)(yao)(yao)(yao)监局关于(yu)发布<突(tu)破性(xing)治(zhi)(zhi)疗(liao)药(yao)(yao)(yao)(yao)(yao)物(wu)审(shen)评(ping)(ping)工(gong)作(zuo)程(cheng)序(xu)(xu)(试(shi)行(xing)(xing))>等三个(ge)文件(jian)的(de)公告》(2020年第82号(hao)),明确了加快(kuai)(kuai)通(tong)道(dao)的(de)适(shi)用(yong)范(fan)围、适(shi)用(yong)条件(jian)、工(gong)作(zuo)程(cheng)序(xu)(xu)和(he)政策支(zhi)持(chi)等,既能显著提(ti)高相关程(cheng)序(xu)(xu)执行(xing)(xing)过程(cheng)中的(de)可操作(zuo)性(xing),鼓(gu)励药(yao)(yao)(yao)(yao)(yao)物(wu)研制和(he)创新(xin),又能在全球抗击疫(yi)情(qing)的(de)大背景下,依(yi)法依(yi)规对疫(yi)情(qing)防控所需(xu)(xu)(xu)药(yao)(yao)(yao)(yao)(yao)物(wu)实行(xing)(xing)特别审(shen)批,对于(yu)加快(kuai)(kuai)临(lin)床(chuang)急(ji)需(xu)(xu)(xu)、临(lin)床(chuang)价(jia)值突(tu)出、公共卫生急(ji)需(xu)(xu)(xu)等药(yao)(yao)(yao)(yao)(yao)物(wu)的(de)上(shang)市(shi)(shi)具有重要推(tui)动作(zuo)用(yong)。2020年已批准上(shang)市(shi)(shi)药(yao)(yao)(yao)(yao)(yao)品(pin)纳(na)入加快(kuai)(kuai)上(shang)市(shi)(shi)程(cheng)序(xu)(xu)情(qing)况(kuang)详见(jian)附件(jian)4。

1.特别审批药物情况

在发(fa)(fa)(fa)生(sheng)(sheng)突发(fa)(fa)(fa)公(gong)共(gong)卫(wei)生(sheng)(sheng)事(shi)件的(de)威胁时(shi)以及突发(fa)(fa)(fa)公(gong)共(gong)卫(wei)生(sheng)(sheng)事(shi)件发(fa)(fa)(fa)生(sheng)(sheng)后,国家(jia)药(yao)(yao)监局可依法决(jue)定对突发(fa)(fa)(fa)公(gong)共(gong)卫(wei)生(sheng)(sheng)事(shi)件应急所需防治药(yao)(yao)品(pin)(pin)实行特(te)别(bie)审(shen)批(pi)。纳入实施特(te)别(bie)审(shen)批(pi)程序的(de)药(yao)(yao)物,国家(jia)药(yao)(yao)监局按(an)照(zhao)统一(yi)指挥、早期(qi)介入、快(kuai)速高效、科学(xue)审(shen)批(pi)的(de)原则(ze),组织加快(kuai)并(bing)同(tong)步(bu)开展药(yao)(yao)品(pin)(pin)注(zhu)册受理(li)、审(shen)评、核查(cha)、检验工作(zuo),并(bing)根据疾病(bing)防控的(de)特(te)定需要,限定其在一(yi)定的(de)期(qi)限和范围内(nei)使用。

2020年新(xin)冠(guan)肺炎(yan)疫(yi)情(qing)在全球范围(wei)内不断蔓(man)延,人民(min)群众(zhong)的(de)生(sheng)命安全受到严重威(wei)胁,药审(shen)中(zhong)心闻(wen)令(ling)而(er)动,第一时(shi)间科(ke)学、高效推进(jin)特别审(shen)评工作(zuo),按(an)程(cheng)(cheng)序(xu)将59件(jian)(jian)中(zhong)药、化学药、生(sheng)物(wu)制品注(zhu)册申(shen)请纳入特别审(shen)批(pi)程(cheng)(cheng)序(xu)并完成技术审(shen)评。建(jian)议附条(tiao)件(jian)(jian)批(pi)准(zhun)上(shang)市1件(jian)(jian),为新(xin)型冠(guan)状病(bing)毒(du)灭(mie)活(huo)疫(yi)苗(miao)(Vero细胞);建(jian)议批(pi)准(zhun)临床试验申(shen)请53件(jian)(jian),其中(zhong)5件(jian)(jian)已(yi)进(jin)入Ⅲ期临床试验,批(pi)准(zhun)化湿败(bai)毒(du)颗(ke)粒、清肺排毒(du)颗(ke)粒的(de)临床试验申(shen)请;批(pi)准(zhun)了(le)连花清瘟胶囊(nang)/颗(ke)粒、金花清感颗(ke)粒及血必净注(zhu)射(she)液等5件(jian)(jian)增加适应症的(de)补充申(shen)请,加速了(le)新(xin)冠(guan)病(bing)毒(du)疫(yi)苗(miao)和新(xin)冠(guan)肺炎(yan)治疗药物(wu)的(de)上(shang)市进(jin)程(cheng)(cheng),初步满(man)足了(le)新(xin)冠(guan)肺炎(yan)疫(yi)情(qing)防(fang)控的(de)需要。

2.突破性治疗药物情况

突破(po)性(xing)(xing)治(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)物(wu)(wu)(wu)指的是(shi)用于(yu)防(fang)治(zhi)(zhi)(zhi)严重危(wei)及生命或(huo)者(zhe)严重影响生存质量的疾病,且(qie)尚无有效防(fang)治(zhi)(zhi)(zhi)手(shou)段(duan)或(huo)者(zhe)与现有治(zhi)(zhi)(zhi)疗(liao)(liao)手(shou)段(duan)相比有足够证据表明具(ju)有明显临床(chuang)优势的创新(xin)药(yao)或(huo)者(zhe)改良型新(xin)药(yao)等(deng),申(shen)(shen)请人可在Ⅰ、Ⅱ临床(chuang)试验阶段(duan)申(shen)(shen)请适用突破(po)性(xing)(xing)治(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)物(wu)(wu)(wu)程序(xu)。根据《突破(po)性(xing)(xing)治(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)物(wu)(wu)(wu)审(shen)(shen)评(ping)工作程序(xu)(试行)》,纳入到(dao)“突破(po)性(xing)(xing)治(zhi)(zhi)(zhi)疗(liao)(liao)”审(shen)(shen)评(ping)通(tong)道的药(yao)物(wu)(wu)(wu),药(yao)审(shen)(shen)中心一是(shi)会优先处理相关(guan)沟通(tong)交(jiao)流,加强指导(dao)并促进(jin)药(yao)物(wu)(wu)(wu)研发进(jin)程;二是(shi)在申(shen)(shen)报(bao)上(shang)市环节,该药(yao)物(wu)(wu)(wu)可适用优先审(shen)(shen)评(ping)审(shen)(shen)批程序(xu),审(shen)(shen)评(ping)时限进(jin)一步缩(suo)短;三是(shi)上(shang)市申(shen)(shen)请阶段(duan),药(yao)审(shen)(shen)中心会滚动接收(shou)其申(shen)(shen)报(bao)资料,并优先安排核查、检验等(deng),可大大缩(suo)减新(xin)药(yao)从研发到(dao)上(shang)市的时间。2020年药(yao)审(shen)(shen)中心收(shou)到(dao)147件(jian)突破(po)性(xing)(xing)治(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)物(wu)(wu)(wu)申(shen)(shen)请。经综合评(ping)估、公示(shi),已将24件(jian)突破(po)性(xing)(xing)治(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)物(wu)(wu)(wu)申(shen)(shen)请(21个品种(zhong))纳入突破(po)性(xing)(xing)治(zhi)(zhi)(zhi)疗(liao)(liao)药(yao)物(wu)(wu)(wu)程序(xu),详见附件(jian)5。

3.附条件批准药物情况

附(fu)条(tiao)件批(pi)准(zhun)上市(shi),目(mu)的(de)在于(yu)缩(suo)短药(yao)(yao)物(wu)临(lin)(lin)床(chuang)试验的(de)研(yan)发时间,使其尽早应(ying)用于(yu)无法继续(xu)等待(dai)的(de)危重疾(ji)病或公共卫生方面急需的(de)患者。药(yao)(yao)物(wu)有(you)效(xiao)性评价的(de)指标为临(lin)(lin)床(chuang)终(zhong)(zhong)点(dian),符合(he)附(fu)条(tiao)件批(pi)准(zhun)上市(shi)情形(xing)的(de)药(yao)(yao)物(wu),可使用替(ti)代终(zhong)(zhong)点(dian)、中(zhong)间临(lin)(lin)床(chuang)终(zhong)(zhong)点(dian)或早期临(lin)(lin)床(chuang)试验数(shu)据来反映药(yao)(yao)物(wu)的(de)有(you)效(xiao)性,当这些数(shu)据能够提(ti)示药(yao)(yao)品的(de)获(huo)益大(da)于(yu)风险时候,即(ji)可申请附(fu)条(tiao)件批(pi)准(zhun)上市(shi)。

对(dui)于若不尽早进行治疗则会在数月或者(zhe)更短时间内(nei)导致死亡的(de)(de)疾病患者(zhe)来说(shuo),附条(tiao)件批准(zhun)上市的(de)(de)药(yao)物,使得这些(xie)无(wu)法继续等待(dai)的(de)(de)患者(zhe)能够延续生命、提高生存质量,消除重(zhong)大突发公共(gong)卫生事件对(dui)于人民生命安全的(de)(de)威胁。2020年药(yao)审中心审评通过的(de)(de)新药(yao)上市申(shen)请中,共(gong)有15件注册申(shen)请经附条(tiao)件批准(zhun)后上市,覆盖了(le)新型冠状病毒感染引起(qi)的(de)(de)疾病、非小细胞(bao)肺(fei)癌(ai)、卵(luan)巢(chao)癌(ai)等适应症。

4.优先审评药物情(qing)况(kuang)

(1)优先审评品种纳入情况

《药品(pin)注(zhu)册管理办法》对优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)程(cheng)序的(de)(de)(de)(de)调(diao)整(zheng),是在多年实践(jian)经验(yan)基(ji)础上的(de)(de)(de)(de)优(you)化,一是适(shi)用(yong)范围更(geng)多地向具有(you)明显临(lin)床价值、临(lin)床急需(xu)和临(lin)床优(you)势的(de)(de)(de)(de)药物聚焦,致(zhi)力于将更(geng)多的(de)(de)(de)(de)临(lin)床价值显著、临(lin)床急需(xu)的(de)(de)(de)(de)短缺药品(pin)、防治重大传染(ran)病、罕见(jian)病、儿童(tong)用(yong)药、纳入突破性治疗程(cheng)序、符合附条件批(pi)(pi)准(zhun)的(de)(de)(de)(de)药品(pin)等纳入优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)程(cheng)序;二(er)是审(shen)(shen)(shen)(shen)评(ping)时限(xian)(xian)的(de)(de)(de)(de)加速(su),药品(pin)上市(shi)许可申(shen)请的(de)(de)(de)(de)审(shen)(shen)(shen)(shen)评(ping)时限(xian)(xian)一般为200个工(gong)作(zuo)日,与(yu)完(wan)整(zheng)的(de)(de)(de)(de)申(shen)报(bao)路(lu)径相比,优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)程(cheng)序的(de)(de)(de)(de)审(shen)(shen)(shen)(shen)评(ping)时限(xian)(xian)缩短至130个工(gong)作(zuo)日,其中(zhong)临(lin)床急需(xu)境外(wai)已上市(shi)罕见(jian)病用(yong)药优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)程(cheng)序的(de)(de)(de)(de)审(shen)(shen)(shen)(shen)评(ping)时限(xian)(xian)为70个工(gong)作(zuo)日。药审(shen)(shen)(shen)(shen)中(zhong)心通(tong)过优(you)化审(shen)(shen)(shen)(shen)评(ping)资源配置(zhi)率(lv),在高标准(zhun)完(wan)成(cheng)技术审(shen)(shen)(shen)(shen)评(ping)的(de)(de)(de)(de)前提(ti)下,力争按(an)时限(xian)(xian)完(wan)成(cheng)审(shen)(shen)(shen)(shen)评(ping),推动纳入优(you)先(xian)审(shen)(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)(shen)批(pi)(pi)程(cheng)序中(zhong)的(de)(de)(de)(de)品(pin)种(zhong)尽(jin)快获批(pi)(pi)上市(shi)。

根据《药(yao)品(pin)(pin)注(zhu)册(ce)管理办法(fa)》、46号(hao)(hao)公告(gao)、《国(guo)家食(shi)品(pin)(pin)药(yao)品(pin)(pin)监督管理总局关(guan)于鼓励药(yao)品(pin)(pin)创新(xin)实行(xing)优(you)先(xian)(xian)审(shen)评审(shen)批的(de)(de)意见》(食(shi)药(yao)监药(yao)化管〔2017〕126号(hao)(hao),以下简称126号(hao)(hao)文件(jian)),2020年药(yao)审(shen)中心将219件(jian)(按通用名(ming)计127个品(pin)(pin)种)注(zhu)册(ce)申(shen)请纳入优(you)先(xian)(xian)审(shen)评审(shen)批程(cheng)序。其中,144件(jian)注(zhu)册(ce)申(shen)请按照126号(hao)(hao)文件(jian)规(gui)定的(de)(de)范围纳入优(you)先(xian)(xian)审(shen)评审(shen)批程(cheng)序,75件(jian)按照《药(yao)品(pin)(pin)注(zhu)册(ce)管理办法(fa)》规(gui)定的(de)(de)范围纳入优(you)先(xian)(xian)审(shen)评审(shen)批程(cheng)序,包括42件(jian)儿童(tong)用药(yao)和罕见病用药(yao)。2016-2020年纳入优(you)先(xian)(xian)审(shen)评审(shen)批程(cheng)序的(de)(de)各类注(zhu)册(ce)申(shen)请情况详见表6和表7。

   

 

 

  按(an)此前优先审评(ping)范围纳入的注册申请中,同步申报占(zhan)比(bi)多达44%(64/144),具(ju)有明显临(lin)床(chuang)价(jia)值的新药(yao)占(zhan)比(bi)为20%,按(an)与原研药(yao)质量和(he)疗效一致(zhi)的标准完(wan)善后重新申报品种占(zhan)比(bi)则由7.9%降(jiang)至4.2%。

按照《药(yao)(yao)品注(zhu)册(ce)管理办法》优(you)先审评范围(wei)纳入的注(zhu)册(ce)申请(qing)中(zhong),符合附条件批准的药(yao)(yao)品占比为36%(27/75),创新药(yao)(yao)和儿童用药(yao)(yao)占比28%(21/75),优(you)先审评资(zi)源已(yi)向具有明显临床价(jia)值的创新、急需(xu)药(yao)(yao)物倾斜。

(2)优先审评品种完成情(qing)况

2020年有217件注(zhu)册申(shen)请(按通(tong)(tong)(tong)用名计(ji)121个品种)通(tong)(tong)(tong)过(guo)优先审评(ping)程(cheng)序建(jian)议批准上(shang)市(含(han)已上(shang)市药(yao)(yao)(yao)(yao)品新(xin)(xin)增适应症),审评(ping)通(tong)(tong)(tong)过(guo)件数较(jiao)2019年增长51.7%,例如:我国自主研发(fa)的(de)1类创新(xin)(xin)药(yao)(yao)(yao)(yao)甲(jia)磺酸阿(a)美替尼(ni)片、泽布替尼(ni)胶囊、奥布替尼(ni)片等,治疗(liao)(liao)罕见病法(fa)布雷病阿(a)加糖酶α注(zhu)射用浓(nong)溶液,用于配合饮(yin)食控(kong)制及运(yun)动(dong)治疗(liao)(liao)2型(xing)糖尿(niao)病的(de)中(zhong)药(yao)(yao)(yao)(yao)新(xin)(xin)药(yao)(yao)(yao)(yao)桑枝总生物碱(jian)片、间变性(xing)淋巴瘤激酶抑制剂(ji)盐酸恩沙(sha)替尼(ni)胶囊、成人复(fu)发(fa)型(xing)多发(fa)性(xing)硬化治疗(liao)(liao)药(yao)(yao)(yao)(yao)物西尼(ni)莫德片等。2016-2020年优先审评(ping)通(tong)(tong)(tong)过(guo)的(de)品种情(qing)况详见表8。

 

(八)药品注册现(xian)场(chang)核查相(xiang)关(guan)情(qing)况

1.总体情况(kuang)

药审(shen)中(zhong)(zhong)心积极落实《药品注(zhu)册(ce)(ce)(ce)管理办法》,转变药品注(zhu)册(ce)(ce)(ce)核查(cha)理念,将注(zhu)册(ce)(ce)(ce)现(xian)(xian)场(chang)核查(cha)启(qi)动工(gong)作模式由(you)基于(yu)审(shen)评需要调整(zheng)为基于(yu)风险启(qi)动,并联开展(zhan)技术(shu)审(shen)评与注(zhu)册(ce)(ce)(ce)现(xian)(xian)场(chang)核查(cha)工(gong)作;对于(yu)自2020年7月1日(ri)起(qi)受(shou)理的注(zhu)册(ce)(ce)(ce)申请,在受(shou)理后40个工(gong)作日(ri)内(nei)决定是否启(qi)动相(xiang)(xiang)应注(zhu)册(ce)(ce)(ce)现(xian)(xian)场(chang)核查(cha)任务。为便于(yu)申请人及时获知注(zhu)册(ce)(ce)(ce)现(xian)(xian)场(chang)核查(cha)启(qi)动相(xiang)(xiang)关信息,完善药审(shen)中(zhong)(zhong)心网(wang)站申请人之窗(chuang)栏目,开通递(di)交注(zhu)册(ce)(ce)(ce)现(xian)(xian)场(chang)核查(cha)用生产工(gong)艺(yi)与质量标准(zhun)通道和查(cha)收(shou)注(zhu)册(ce)(ce)(ce)现(xian)(xian)场(chang)核查(cha)电子通知函的功(gong)能。

2.注册现(xian)场核(he)查具(ju)体情况

2020年,药审中(zhong)心基于品种(zhong)因(yin)素和研(yan)发生(sheng)产主体合(he)规因(yin)素风险启动注册现场核查任(ren)务(wu)1235个(ge)。其(qi)中(zhong),药学(xue)现场核查任(ren)务(wu)792个(ge),临床试验数据核查任(ren)务(wu)439个(ge),药理毒理研(yan)究核查任(ren)务(wu)4个(ge)。

药(yao)(yao)(yao)审(shen)中心接收核(he)查报(bao)(bao)告(gao)818份。其中,药(yao)(yao)(yao)学现场核(he)查报(bao)(bao)告(gao)449份,临床试(shi)验核(he)查报(bao)(bao)告(gao)363份,药(yao)(yao)(yao)理毒理研究(jiu)核(he)查报(bao)(bao)告(gao)6份。

(九)沟通交流(liu)情况

1.总体情(qing)况

2020年,药(yao)审(shen)中(zhong)心(xin)在落实疫(yi)情防控(kong)要求的(de)(de)同时,尽量满足申请(qing)(qing)(qing)人(ren)(ren)的(de)(de)需要,全力(li)保障各类沟(gou)通(tong)交(jiao)流畅(chang)通(tong)。在推(tui)动新冠(guan)病(bing)(bing)毒疫(yi)苗和(he)(he)新冠(guan)肺(fei)(fei)炎(yan)治疗药(yao)物的(de)(de)研发(fa)方面,为79个(ge)新冠(guan)病(bing)(bing)毒疫(yi)苗,中(zhong)医药(yao)、中(zhong)和(he)(he)抗体(27个(ge))等新冠(guan)肺(fei)(fei)炎(yan)治疗药(yao)物,组织申请(qing)(qing)(qing)人(ren)(ren)与药(yao)审(shen)中(zhong)心(xin)审(shen)评团(tuan)队之间的(de)(de)沟(gou)通(tong)交(jiao)流5600余次(ci),并针对新冠(guan)病(bing)(bing)毒疫(yi)苗、中(zhong)和(he)(he)抗体等重点品(pin)种,单(dan)独(du)设立了(le)台账,动态跟(gen)进(jin);在维护与申请(qing)(qing)(qing)人(ren)(ren)沟(gou)通(tong)桥梁方面,药(yao)审(shen)中(zhong)心(xin)发(fa)布了(le)《药(yao)物研发(fa)与技(ji)术审(shen)评沟(gou)通(tong)交(jiao)流管理(li)办法》《药(yao)审(shen)中(zhong)心(xin)关于(yu)业务咨询(xun)服务联(lian)络方式(shi)的(de)(de)通(tong)知》,优化了(le)电(dian)话咨询(xun)服务,每天(tian)有专人(ren)(ren)接听(ting)解(jie)答申请(qing)(qing)(qing)人(ren)(ren)咨询(xun)电(dian)话,根据(ju)咨询(xun)问题类型(xing)的(de)(de)不同设立了(le)8个(ge)联(lian)系邮(you)箱,及时解(jie)答处理(li)申请(qing)(qing)(qing)人(ren)(ren)问题,不断提高沟(gou)通(tong)交(jiao)流的(de)(de)质量和(he)(he)效率。

药审中心接(jie)收沟通交流会(hui)议申(shen)请(qing)3229件,较(jiao)2019年(nian)(nian)增(zeng)长(zhang)22.64%,办理沟通交流会(hui)议申(shen)请(qing)2451件,较(jiao)2019年(nian)(nian)增(zeng)长(zhang)31.00%。在网络平台接(jie)收一般(ban)性技术问题咨(zi)询(xun)20285个,较(jiao)2019年(nian)(nian)增(zeng)长(zhang)22.41%;接(jie)收电(dian)话咨(zi)询(xun)超过上万次,邮(you)件咨(zi)询(xun)数(shu)千(qian)件,同(tong)时也面向社会(hui)提供现(xian)场咨(zi)询(xun)服务。2016-2020年(nian)(nian)接(jie)收沟通交流申(shen)请(qing)和一般(ban)性技术问题咨(zi)询(xun)具(ju)体情况详见图16。

 

2.沟通交流会议申请(qing)的(de)完成(cheng)情况

药(yao)审(shen)中(zhong)心所接收的3229件沟(gou)通交流(liu)(liu)会(hui)议(yi)(yi)申请中(zhong),符(fu)合(he)会(hui)议(yi)(yi)召开(kai)(kai)条件的,及(ji)时与申请人(ren)取(qu)得了(le)联(lian)系,商议(yi)(yi)会(hui)议(yi)(yi)细(xi)节;无需召开(kai)(kai)会(hui)议(yi)(yi)的,以书面形式尽快(kuai)回复了(le)申请人(ren)。2020年(nian)共办理了(le)2451件沟(gou)通交流(liu)(liu)会(hui)议(yi)(yi)申请。在药(yao)物研发关键阶(jie)段召开(kai)(kai)的Ⅱ类会(hui)议(yi)(yi)占比76.42%,其中(zhong)临(lin)床前(Pre-IND)申请占比37.49%。2020年(nian)各类沟(gou)通交流(liu)(liu)会(hui)议(yi)(yi)申请及(ji)办理情(qing)况(kuang)详见表9。

 

  沟(gou)通(tong)交流(liu)会(hui)议(yi)的形式为电话会(hui)议(yi)、视频会(hui)议(yi)、面对面会(hui)议(yi),共召开沟(gou)通(tong)交流(liu)会(hui)议(yi)268次,以书面形式回(hui)复(fu)两千余件。2018-2020年各类沟(gou)通(tong)交流(liu)会(hui)议(yi)的召开情况详见(jian)表10。

 

3.一般性技术问题(ti)答复情况(kuang)

药(yao)(yao)审中(zhong)心通过网上咨(zi)询(xun)平台共(gong)接收了(le)20285个(ge)(ge)(ge)(ge)(ge)一(yi)般性(xing)技(ji)术(shu)(shu)问题(ti)的咨(zi)询(xun)。按照内容分(fen)类,问题(ti)主(zhu)(zhu)要集中(zhong)于(yu)受理(4038个(ge)(ge)(ge)(ge)(ge))、原辅包(3952个(ge)(ge)(ge)(ge)(ge))等方面;按照药(yao)(yao)品(pin)分(fen)类,问题(ti)主(zhu)(zhu)要集中(zhong)于(yu)化学(xue)药(yao)(yao)(11338个(ge)(ge)(ge)(ge)(ge))方面,其(qi)中(zhong)化学(xue)药(yao)(yao)受理(2396个(ge)(ge)(ge)(ge)(ge))、化学(xue)药(yao)(yao)一(yi)致性(xing)评(ping)价(1258个(ge)(ge)(ge)(ge)(ge))。一(yi)般性(xing)技(ji)术(shu)(shu)问题(ti)答复具体情(qing)况详见表11。

 

二、药品注册申请受理情况

(一)总(zong)体情况

2020年,根据46号(hao)公告、《国家(jia)药(yao)(yao)(yao)监(jian)(jian)局关(guan)于发(fa)布(bu)(bu)生物制品(pin)(pin)注(zhu)册(ce)分类(lei)及申报(bao)(bao)资料要求的通告》(2020年第43号(hao))、《国家(jia)药(yao)(yao)(yao)监(jian)(jian)局关(guan)于发(fa)布(bu)(bu)化学(xue)药(yao)(yao)(yao)品(pin)(pin)注(zhu)册(ce)分类(lei)及申报(bao)(bao)资料要求的通告》(2020年第44号(hao))、《国家(jia)药(yao)(yao)(yao)监(jian)(jian)局关(guan)于发(fa)布(bu)(bu)<中(zhong)药(yao)(yao)(yao)注(zhu)册(ce)分类(lei)及申报(bao)(bao)资料要求>的通告》(2020年第68号(hao))等(deng),药(yao)(yao)(yao)审中(zhong)心(xin)受理(li)中(zhong)药(yao)(yao)(yao)、化学(xue)药(yao)(yao)(yao)、生物制品(pin)(pin)各(ge)类(lei)注(zhu)册(ce)申请(qing)共10245件(jian)(含药(yao)(yao)(yao)械组合产品(pin)(pin)6件(jian)),较(jiao)(jiao)2019年增长(zhang)26.76%。其(qi)中(zhong),需(xu)(xu)技(ji)术审评的注(zhu)册(ce)申请(qing)7147件(jian)(含5695件(jian)需(xu)(xu)药(yao)(yao)(yao)审中(zhong)心(xin)技(ji)术审评和行(xing)政(zheng)(zheng)审批(pi)的注(zhu)册(ce)申请(qing)),较(jiao)(jiao)2019年增长(zhang)15.29%;直接行(xing)政(zheng)(zheng)审批(pi)的注(zhu)册(ce)申请(qing)3092件(jian),较(jiao)(jiao)2019年增长(zhang)64.64%。

受理(li)的(de)10239件药(yao)品注册申请中,化(hua)学药(yao)注册申请受理(li)量(liang)为(wei)7901件,较2019年增长22.02%,占2020年全部(bu)注册申请受理(li)量(liang)的(de)77.17%,2016-2020年各(ge)类药(yao)品注册申请受理(li)情况详见(jian)图17。

 

2.药审中心(xin)的直(zhi)接行政审批工作自(zi)2017年(nian)开始,故(gu)2016年(nian)无直(zhi)接行政审批注(zhu)册(ce)申请(qing),所(suo)有(you)受理注(zhu)册(ce)申请(qing)均需技术审评。

2020年(nian)受理(li)的(de)需(xu)(xu)技(ji)术审评的(de)注(zhu)(zhu)册申(shen)请(qing)7147件(jian)(jian)中(zhong),化学药注(zhu)(zhu)册申(shen)请(qing)为5402件(jian)(jian),较2019年(nian)增长(zhang)9.42%,占全部(bu)需(xu)(xu)技(ji)术审评的(de)注(zhu)(zhu)册申(shen)请(qing)受理(li)量的(de)75.58%;中(zhong)药注(zhu)(zhu)册申(shen)请(qing)315件(jian)(jian),较2019年(nian)增长(zhang)22.57%;生(sheng)物(wu)制品注(zhu)(zhu)册申(shen)请(qing)1430件(jian)(jian),较2019年(nian)增长(zhang)42.29%。2016-2020年(nian)需(xu)(xu)技(ji)术审评的(de)中(zhong)药、化学药、生(sheng)物(wu)制品各(ge)类注(zhu)(zhu)册申(shen)请(qing)受理(li)情况详见(jian)图18。

 

(二)1类创新药受(shou)理情况

2020年,药(yao)(yao)(yao)(yao)审中(zhong)心(xin)受(shou)理(li)(li)1类创(chuang)新药(yao)(yao)(yao)(yao)注册申请(qing)共1062件(597个(ge)品(pin)(pin)种),较2019年增长51.71%。其中(zhong),受(shou)理(li)(li)IND申请(qing)1008件(559个(ge)品(pin)(pin)种),较2019年增长49.78%;受(shou)理(li)(li)NDA 54件(38个(ge)品(pin)(pin)种),较2019年增长100.00%。以药(yao)(yao)(yao)(yao)品(pin)(pin)类别统计,中(zhong)药(yao)(yao)(yao)(yao)、化学药(yao)(yao)(yao)(yao)、生(sheng)(sheng)(sheng)物制品(pin)(pin)1类创(chuang)新药(yao)(yao)(yao)(yao)受(shou)理(li)(li)量分别为14、752、296件。以生(sheng)(sheng)(sheng)产场地统计,境内生(sheng)(sheng)(sheng)产药(yao)(yao)(yao)(yao)品(pin)(pin)843件,境外生(sheng)(sheng)(sheng)产药(yao)(yao)(yao)(yao)品(pin)(pin)219件。详(xiang)见表(biao)12和13。

 

(三)各类注(zhu)册申请受理情况(kuang)

1.中药注册申请受(shou)理情况

2020年,药(yao)(yao)审中(zhong)(zhong)心受(shou)理(li)(li)(li)中(zhong)(zhong)药(yao)(yao)注册(ce)申请(qing)(qing)471件。其中(zhong)(zhong),受(shou)理(li)(li)(li)中(zhong)(zhong)药(yao)(yao)IND申请(qing)(qing)22件,受(shou)理(li)(li)(li)中(zhong)(zhong)药(yao)(yao)NDA 6件,受(shou)理(li)(li)(li)中(zhong)(zhong)药(yao)(yao)ANDA 1件。2020年中(zhong)(zhong)药(yao)(yao)各类注册(ce)申请(qing)(qing)受(shou)理(li)(li)(li)情况详(xiang)见(jian)图19。

 

  受理1类(lei)中药创新药注(zhu)册申请14件(jian)。其(qi)中,受理IND 申请9件(jian)(9个品种),受理NDA 5件(jian)(5个品种)。

2.化(hua)学药注册申(shen)请受理情况

2020年(nian)(nian),药(yao)审中(zhong)心受理(li)化学(xue)(xue)药(yao)注(zhu)册(ce)申(shen)(shen)(shen)(shen)请7901。其中(zhong),受理(li)化学(xue)(xue)药(yao)IND申(shen)(shen)(shen)(shen)请946件(jian)(jian),较(jiao)2019年(nian)(nian)增(zeng)长36.31%;受理(li)化学(xue)(xue)药(yao)NDA 191件(jian)(jian),较(jiao)2019年(nian)(nian)增(zeng)长46.92%;受理(li)ANDA 1125件(jian)(jian),较(jiao)2019年(nian)(nian)增(zeng)长7.45%;受理(li)一致性评价申(shen)(shen)(shen)(shen)请914件(jian)(jian),较(jiao)2019年(nian)(nian)减少(shao)11.95%。2020年(nian)(nian)化学(xue)(xue)药(yao)各(ge)类注(zhu)册(ce)申(shen)(shen)(shen)(shen)请受理(li)情况详见(jian)图20。2016-2020年(nian)(nian)化学(xue)(xue)药(yao)各(ge)类注(zhu)册(ce)申(shen)(shen)(shen)(shen)请受理(li)情况详见(jian)图21。

 

 

药审中心受(shou)理1类创(chuang)新(xin)化学药注册申(shen)请752件(360个(ge)品种(zhong)(zhong)),较(jiao)2019年增长(zhang)31.24%。其中,受(shou)理IND申(shen)请721件(339个(ge)品种(zhong)(zhong)),较(jiao)2019年增长(zhang)30.62%;受(shou)理NDA 31件(21个(ge)品种(zhong)(zhong)),较(jiao)2019年增长(zhang)47.62%。

药审中(zhong)心受理化(hua)学药5.1类(lei)注册(ce)申请160件(jian),较(jiao)2019年增长1.91%。其中(zhong)受理临床(chuang)试验申请(验证性临床(chuang))53件(jian),受理NDA 107件(jian)。

360个品种(zhong)的1类创(chuang)新(xin)化学(xue)药(yao)注册(ce)申请(qing)(qing)中,境内生(sheng)产化学(xue)药(yao)注册(ce)申请(qing)(qing)为258个品种(zhong),境外生(sheng)产化学(xue)药(yao)注册(ce)申请(qing)(qing)为102个品种(zhong)。2016-2020年(nian)1类创(chuang)新(xin)化学(xue)药(yao)注册(ce)申请(qing)(qing)受理情况详见图22。

 

3.生(sheng)物制品注册申请受理情况

2020年(nian),药审中心受(shou)理生(sheng)(sheng)物(wu)(wu)制品(pin)(pin)(pin)(pin)注册(ce)(ce)申(shen)(shen)(shen)请(qing)1867件(jian)(jian)(jian)(jian)。其中,受(shou)理生(sheng)(sheng)物(wu)(wu)制品(pin)(pin)(pin)(pin)IND申(shen)(shen)(shen)请(qing)580件(jian)(jian)(jian)(jian)(预(yu)防(fang)用IND申(shen)(shen)(shen)请(qing)25件(jian)(jian)(jian)(jian),治疗用IND申(shen)(shen)(shen)请(qing)555件(jian)(jian)(jian)(jian)),较(jiao)(jiao)2019年(nian)增长(zhang)87.10%;受(shou)理生(sheng)(sheng)物(wu)(wu)制品(pin)(pin)(pin)(pin)NDA 126件(jian)(jian)(jian)(jian)(预(yu)防(fang)用NDA 7件(jian)(jian)(jian)(jian),治疗用NDA 117件(jian)(jian)(jian)(jian),体外诊(zhen)断试剂2件(jian)(jian)(jian)(jian)),较(jiao)(jiao)2019年(nian)增长(zhang)1.62%。2020年(nian)生(sheng)(sheng)物(wu)(wu)制品(pin)(pin)(pin)(pin)各类注册(ce)(ce)申(shen)(shen)(shen)请(qing)受(shou)理情(qing)况详见图(tu)23。2016-2020年(nian)生(sheng)(sheng)物(wu)(wu)制品(pin)(pin)(pin)(pin)IND申(shen)(shen)(shen)请(qing)和(he)NDA受(shou)理情(qing)况详见图(tu)24。

 

 

 

药审中心受(shou)(shou)理(li)(li)(li)1类创新生物(wu)制(zhi)品(pin)(pin)(pin)注册申(shen)请(qing)296件(223个(ge)品(pin)(pin)(pin)种(zhong)),较2019年增长133.07%。其中,受(shou)(shou)理(li)(li)(li)预防用生物(wu)制(zhi)品(pin)(pin)(pin)5件,受(shou)(shou)理(li)(li)(li)治(zhi)疗用生物(wu)制(zhi)品(pin)(pin)(pin)291件;受(shou)(shou)理(li)(li)(li)生物(wu)制(zhi)品(pin)(pin)(pin)IND申(shen)请(qing)278件(211个(ge)品(pin)(pin)(pin)种(zhong)),较2019年增长129.75%;受(shou)(shou)理(li)(li)(li)生物(wu)制(zhi)品(pin)(pin)(pin)NDA 18件(12个(ge)品(pin)(pin)(pin)种(zhong)),较2019年增长200.00%,具体情况详见(jian)表14。

 

4.行政审批注册申请受(shou)理情况

(1)总体情(qing)况

2020年(nian)(nian),药审(shen)(shen)(shen)中心(xin)受(shou)理(li)需(xu)中心(xin)行(xing)政审(shen)(shen)(shen)批的中药、化学(xue)药、生物制品各类注(zhu)册申请(qing)(qing)8787件(jian),较2019年(nian)(nian)增长29.51%。其中,受(shou)理(li)需(xu)审(shen)(shen)(shen)评(ping)审(shen)(shen)(shen)批的注(zhu)册申请(qing)(qing)(临(lin)床试验申请(qing)(qing)、一致性评(ping)价申请(qing)(qing)、补充(chong)申请(qing)(qing)、境(jing)外生产药品再注(zhu)册及复审(shen)(shen)(shen))5695件(jian),较2019年(nian)(nian)增长16.06%;受(shou)理(li)直(zhi)接行(xing)政审(shen)(shen)(shen)批的注(zhu)册申请(qing)(qing)(无需(xu)技术(shu)审(shen)(shen)(shen)评(ping)的补充(chong)申请(qing)(qing)、临(lin)时进口申请(qing)(qing))3092件(jian),较2019年(nian)(nian)增长64.64%。2020年(nian)(nian)行(xing)政审(shen)(shen)(shen)批注(zhu)册申请(qing)(qing)受(shou)理(li)的具体(ti)情(qing)况详见表15。2016-2020年(nian)(nian)行(xing)政审(shen)(shen)(shen)批注(zhu)册申请(qing)(qing)受(shou)理(li)情(qing)况详见图25。

 

(2)需审评审批的(de)注(zhu)册申(shen)请(qing)受理情况

药审中心受理5695件需审评审批的注册(ce)申请中,临床(chuang)试验申请1618件(含验证性临床(chuang))、一致性评价申请914件、补充(chong)申请2827件、境外生(sheng)产药品再(zai)注册(ce)328件、复审8件。

(3)直接行政审批的注册申请受(shou)理情(qing)况

药(yao)审中(zhong)心(xin)受理(li)3092件直(zhi)接行政审批的注(zhu)册(ce)申请(qing)中(zhong),按申请(qing)类型划(hua)分(fen),补充申请(qing)2644件、临时进口申请(qing)448件。按药(yao)品类型划(hua)分(fen),中(zhong)药(yao)156件、化学药(yao)2499件、生(sheng)物制品437件。

 三、重点治(zhi)疗领域(yu)品种

新(xin)冠病毒疫苗(miao)和新(xin)冠肺炎治疗药物(wu):

1.新(xin)型冠状病(bing)毒(du)灭活(huo)疫(yi)苗(miao)(Vero细(xi)胞),为国内首个附条件批准的(de)新(xin)冠病(bing)毒(du)疫(yi)苗(miao),也是全(quan)球首个新(xin)冠病(bing)毒(du)灭活(huo)疫(yi)苗(miao)。适用于18岁及以(yi)上人群预防由新(xin)型冠状病(bing)毒(du)(SARS-CoV-2)感染引起(qi)的(de)疾病(bing)。

2.“三(san)药(yao)”品种(zhong),为《新型(xing)(xing)冠状病(bing)毒(du)肺(fei)(fei)炎(yan)诊疗(liao)方案(试(shi)行)》推荐药(yao)物,即连(lian)花清瘟颗粒(li)(li)/胶(jiao)囊、金花清感颗粒(li)(li)和(he)血(xue)(xue)必(bi)净注(zhu)射液。连(lian)花清瘟颗粒(li)(li)/胶(jiao)囊和(he)金花清感颗粒(li)(li)新增(zeng)适应(ying)症用于(yu)在(zai)新型(xing)(xing)冠状病(bing)毒(du)肺(fei)(fei)炎(yan)的常规治疗(liao)中(zhong)的轻型(xing)(xing)、普通(tong)型(xing)(xing)引起的发热、咳嗽、乏(fa)力(li),血(xue)(xue)必(bi)净注(zhu)射液新增(zeng)适应(ying)症用于(yu)新型(xing)(xing)冠状病(bing)毒(du)肺(fei)(fei)炎(yan)重型(xing)(xing)、危重型(xing)(xing)的全身炎(yan)症反应(ying)综合征或/和(he)多脏器(qi)功(gong)能衰竭(jie),其获批上市充分发挥了中(zhong)医(yi)药(yao)在(zai)疫情防控中(zhong)的作(zuo)用。

3.注射用(yong)西维来司他(ta)钠,为(wei)中性(xing)粒细胞(bao)弹性(xing)蛋白酶(mei)选择性(xing)抑制剂,适用(yong)于(yu)改善伴有全身性(xing)炎(yan)症(zheng)反应综合征(zheng)(zheng)的急性(xing)肺损伤/急性(xing)呼吸(xi)窘迫综合征(zheng)(zheng)(ALI/ARDS),是(shi)全球(qiu)唯(wei)一用(yong)于(yu)ALI/ARDS的药物(wu),其获批上市填补了我国ALI/ARDS药物(wu)治疗(liao)领域的空(kong)白,为(wei)我国呼吸(xi)系(xi)统危重症(zheng)患者提供用(yong)药选择。

抗肿瘤药(yao)物:

4.甲磺酸(suan)(suan)阿(a)美(mei)替尼(ni)片,为我(wo)国首个具有自主(zhu)知(zhi)识产权的(de)第(di)三代靶向表皮(pi)生长因(yin)子(zi)(zi)受体(EGFR)小(xiao)分(fen)子(zi)(zi)酪氨酸(suan)(suan)激(ji)酶抑制剂(ji)(TKI)创新药物(wu),适用于治疗既往经(jing)EGFR-TKI治疗时或治疗后出(chu)现疾病进展,并且经(jing)检测确(que)认存在EGFR T790M突变阳性的(de)局(ju)部(bu)晚期(qi)或转移性非小(xiao)细(xi)胞肺癌。本品疗效突出(chu),脑转移病灶控制良好,其(qi)获批上(shang)市将显著改善该疾病治疗药物(wu)的(de)可及性。

5.索凡替(ti)尼胶(jiao)囊,为多靶点、抗血管生成口服小分子(zi)酪氨酸激酶抑制剂,是国内首个(ge)用于(yu)治疗无法手(shou)术切除的(de)局部晚(wan)期或转移性、进展期非(fei)功能性、分化良好(hao)(G1、G2)的(de)非(fei)胰(yi)腺来源的(de)神(shen)经(jing)内分泌(mi)瘤的(de)创新药物。本品疗效(xiao)突出,显著(zhu)降(jiang)低了此类(lei)患者的(de)疾(ji)病(bing)进展和死亡风险,其获批上(shang)市填补了该疾(ji)病(bing)治疗领(ling)域的(de)空白。

6.注射(she)用维布(bu)妥昔(xi)单抗(kang),为(wei)全球(qiu)首(shou)个CD30靶点(dian)抗(kang)体偶联(lian)药物(ADC),也(ye)是(shi)国内首(shou)个用于恶性淋巴瘤(liu)患者的(de)(de)ADC药物,适用于治疗复(fu)发或难治性的(de)(de)系统性间变(bian)性大细胞(bao)淋巴瘤(liu)和(he)经典型霍奇金淋巴瘤(liu),本品(pin)获批(pi)上市为(wei)改善我国此类患者的(de)(de)长期生存提供了有效的(de)(de)治疗手(shou)段(duan)。

7.注射用贝林妥欧单抗,为(wei)(wei)全球(qiu)首(shou)个双特异性(xing)抗体(ti)(CD3和(he)CD19靶点)药物,也是(shi)我(wo)国首(shou)个用于肿瘤适(shi)应(ying)症(zheng)的双特异性(xing)抗体(ti)药物,适(shi)用于治(zhi)疗成人复(fu)发或难治(zhi)性(xing)前(qian)体(ti)B细胞急(ji)性(xing)淋巴细胞白(bai)血病(bing)。对于化(hua)(hua)疗失败的复(fu)发或难治(zhi)性(xing)急(ji)性(xing)淋巴细胞白(bai)血病(bing)患者,与标准(zhun)化(hua)(hua)疗相比,本品可显著延长患者生存(cun)期,其获批(pi)上市(shi)为(wei)(wei)我(wo)国此类患者提供了更好(hao)的治(zhi)疗手段。

8.甲磺酸(suan)仑(lun)伐替尼胶(jiao)囊,为(wei)多靶点、口服酪氨酸(suan)激(ji)酶(mei)抑(yi)制(zhi)剂(ji),是国(guo)内(nei)首个用于治(zhi)疗进展(zhan)性(xing)、局部晚期或转移性(xing)放射性(xing)碘难治(zhi)性(xing)分化(hua)型甲状腺癌的(de)小分子(zi)药物。本品疗效(xiao)突出(chu),其获批(pi)上市为(wei)我国(guo)此类患者提供了(le)有(you)效(xiao)的(de)治(zhi)疗方案,填(tian)补了(le)该(gai)治(zhi)疗领域的(de)空白(bai)。

抗感染药物:

9.盐酸可洛派韦胶囊(nang),为非结构蛋白5A(NS5A)抑(yi)制剂,是我(wo)国具有自(zi)主(zhu)知识产权的广谱(pu)、直接抗丙肝(gan)病(bing)毒创新(xin)药物,适用于与索磷(lin)布韦联用治(zhi)(zhi)疗初治(zhi)(zhi)或(huo)干扰(rao)素(su)经治(zhi)(zhi)的基因1、2、3、6型(xing)成人(ren)慢性丙型(xing)肝(gan)炎病(bing)毒感(gan)染,可合(he)并或(huo)不合(he)并代偿性肝(gan)硬(ying)化(hua),本品获(huo)批上市(shi)为我(wo)国慢性丙肝(gan)患者提(ti)供(gong)了一(yi)种新(xin)的治(zhi)(zhi)疗选择。

10.恩(en)曲他滨替诺(nuo)福韦片,增加适应(ying)症用于降低成人和青(qing)少年(体重(zhong)至少在35 kg以上)通过高风(feng)险性行为获得(de)HIV-1的风(feng)险,是国(guo)内首个(ge)用于暴露(lu)前预防HIV的药物。HIV感染(ran)是重(zhong)大公共(gong)卫生(sheng)问(wen)题,本品(pin)获批(pi)上市对于控制HIV传播(bo)具有重(zhong)大意义。

循环系(xi)统药(yao)物:

11.拉那利尤单(dan)抗注射液,为全人源(yuan)化单(dan)克隆(long)抗体(IgG1/K-轻链),是(shi)我(wo)(wo)国首(shou)个用于12岁及以上患(huan)者预防遗传(chuan)性血管性水肿(HAE)发作(zuo)的药物。HAE疾病(bing)反复发作(zuo),近半(ban)数(shu)患(huan)者可出现上呼吸道黏膜水肿引发窒息而危及生命(ming),本(ben)品获(huo)批上市为我(wo)(wo)国HAE患(huan)者预防发作(zuo)提供了安全有效的治疗(liao)手段。

12.氯苯唑酸软(ruan)胶囊,为(wei)转(zhuan)甲状(zhuang)腺(xian)素蛋白(TTR)稳(wen)定剂,适用于治疗(liao)转(zhuan)甲状(zhuang)腺(xian)素蛋白淀粉样变性心(xin)肌病(bing),以(yi)减(jian)少(shao)心(xin)血(xue)管死(si)亡及(ji)心(xin)血(xue)管相关(guan)住院。该(gai)(gai)疾病(bing)是一(yi)种致命性疾病(bing),属罕见(jian)病(bing),本品为(wei)我国首(shou)个针(zhen)对(dui)该(gai)(gai)病(bing)病(bing)因治疗(liao)的药物,其获批上市为(wei)我国此类患(huan)者提供了(le)新的治疗(liao)手段。

呼吸系统药物:

13.苯环喹溴铵鼻喷雾(wu)剂(ji),为胆(dan)(dan)碱(jian)能受体拮抗剂(ji),为我国首个具有(you)自主知识产权用于(yu)变应(ying)性(xing)鼻炎的鼻用抗胆(dan)(dan)碱(jian)创新(xin)(xin)药(yao)物,适用于(yu)改善变应(ying)性(xing)鼻炎引起的流涕、鼻塞、鼻痒和(he)喷嚏症(zheng)状,本品其获批(pi)上市可为我国此类患(huan)者(zhe)提供新(xin)(xin)的治疗(liao)选择。

14.乙磺酸尼(ni)达尼(ni)布软(ruan)胶囊,为(wei)小分子(zi)酪氨酸激酶抑制剂,具有(you)(you)抗纤(xian)维化(hua)作用,增加适应症用于治疗(liao)系统性硬化(hua)病(bing)相关间质(zhi)性肺(fei)疾病(bing)(SSc-ILD)和具有(you)(you)进(jin)行性表型的慢性纤(xian)维化(hua)性间质(zhi)性肺(fei)疾病(bing)(PF-ILD)。目前可用于SSc-ILD和PF-ILD的有(you)(you)效治疗(liao)方(fang)式有(you)(you)限(xian),临床(chuang)用药需求迫切(qie),本品获批新增适应症可以填补该治疗(liao)领域空(kong)白,为(wei)我国(guo)此类患者提供药物选择。

神经(jing)系统药物:

15.氘丁苯那嗪片,为囊泡单胺转运(yun)蛋白2(VMAT2)抑制剂,是(shi)我(wo)国首个用(yong)于治疗与罕(han)见病亨廷顿病有关的(de)(de)舞蹈病、迟发(fa)性运(yun)动(dong)障(zhang)碍的(de)(de)药物,属临床急需(xu)境外(wai)新药名(ming)单品种(zhong),本品获批上(shang)市(shi)满(man)足了我(wo)国此类患者迫切的(de)(de)临床需(xu)求。

16.氯苯唑酸葡胺软胶囊,为(wei)转(zhuan)甲状(zhuang)(zhuang)腺素(su)蛋白(TTR)稳定(ding)剂,是(shi)我国首个(ge)用于治疗成(cheng)人转(zhuan)甲状(zhuang)(zhuang)腺素(su)蛋白淀(dian)粉样变性多发性神经病(bing)(bing)I期症状(zhuang)(zhuang)患者、延缓周围神经功能损害的(de)(de)药物(wu),属临床(chuang)急需境外新药名单品种,其(qi)获批上市改变了该病(bing)(bing)无药可治的(de)(de)局面。

镇痛(tong)药及麻醉科药物:

17.环泊酚注射液,为(wei)GABAA受体激动剂,是用于消(xiao)化道内镜(jing)检(jian)查中镇静的(de)创新药物(wu)。本品与临床常用麻(ma)醉镇静药物(wu)丙泊酚具有相似的(de)药理(li)机制,但具有起效快(kuai),注射痛(tong)少,呼(hu)吸抑制轻,恢复(fu)速度快(kuai)等优(you)势(shi)特征,其(qi)获批上市可为(wei)我(wo)国消(xiao)化内镜(jing)检(jian)查操作用药提供新的(de)选(xuan)择。

皮肤五官药物:

18.塞奈吉(ji)明滴眼液,为(wei)国(guo)(guo)内(nei)首个用于治疗(liao)神经(jing)营养性(xing)角膜(mo)炎(NK)的重(zhong)组人神经(jing)生长因子(rhNGF)药(yao)物,属临床急需境外新药(yao)名单品(pin)种。NK为(wei)罕见的退行性(xing)角膜(mo)疾病(bing),可致盲,中重(zhong)度NK手术(shu)治疗(liao)为(wei)侵(qin)入性(xing)操作(zuo),费用高且(qie)不能永久治愈,本品(pin)获批上(shang)市(shi)为(wei)我国(guo)(guo)此类患(huan)者提(ti)供(gong)了(le)有效(xiao)的治疗(liao)药(yao)物,预计将成为(wei)中重(zhong)度NK患(huan)者的首选治疗(liao)。

19.度(du)普利(li)尤单抗(kang)注射(she)液,为(wei)重(zhong)组人免疫球蛋(dan)白(bai)-G4单克(ke)隆抗(kang)体,适用于(yu)治(zhi)疗(liao)(liao)(liao)外(wai)(wai)用处方(fang)药控制不佳或不建议使用外(wai)(wai)用处方(fang)药的(de)成人中重(zhong)度(du)特应性皮炎(yan),属(shu)临(lin)床急(ji)需(xu)境(jing)外(wai)(wai)新药名单品(pin)种。与现有治(zhi)疗(liao)(liao)(liao)方(fang)式相比,本品(pin)有明显(xian)临(lin)床优势,其获批(pi)上市为(wei)此(ci)类难治(zhi)性严重(zhong)疾病患者(zhe)提供了治(zhi)疗(liao)(liao)(liao)选择。

消化系统药(yao)物(wu):

20.注(zhu)射用维得利珠单抗(kang)(kang),为(wei)(wei)作用于人淋巴(ba)细胞整合素α4β7的(de)(de)人源化(hua)单克(ke)隆抗(kang)(kang)体,适用于治(zhi)疗(liao)对传统(tong)治(zhi)疗(liao)或肿瘤坏死因(yin)子α(TNF-α)抑制剂应答(da)不(bu)(bu)充分(fen)、失(shi)应答(da)或不(bu)(bu)耐受的(de)(de)中度至(zhi)重度活动性(xing)溃疡性(xing)结肠炎、克(ke)罗恩(en)病,属临(lin)床(chuang)(chuang)急需(xu)境(jing)外(wai)新药名单品种。此类(lei)疾病存(cun)在迫切(qie)的(de)(de)临(lin)床(chuang)(chuang)治(zhi)疗(liao)需(xu)求,特别是(shi)对于TNF-α拮(jie)抗(kang)(kang)剂治(zhi)疗(liao)失(shi)败(bai)的(de)(de)患者,本品获批上市可为(wei)(wei)临(lin)床(chuang)(chuang)提供新的(de)(de)治(zhi)疗(liao)选(xuan)择(ze)。

外科药物:

21.注射用丹曲林钠,适用于预防及(ji)治疗恶性高热(MH),是目(mu)前唯一(yi)短(duan)时间内给(ji)药可改变该疾(ji)病转(zhuan)归的药物。MH临床结局危(wei)重,死(si)亡率高,其获批上市可改变目(mu)前国内MH无安全有效治疗手段(duan)的现(xian)状,满足迫切临床需求。

22.他(ta)克(ke)莫司颗粒,适用于预防儿童肝脏(zang)或肾脏(zang)移(yi)植术(shu)(shu)后的移(yi)植物(wu)排斥反应,治疗儿童肝脏(zang)或肾脏(zang)移(yi)植术(shu)(shu)后应用其他(ta)免疫抑制(zhi)药物(wu)无法控制(zhi)的移(yi)植物(wu)排斥反应,属儿童用药,本(ben)品(pin)获批(pi)上(shang)市可极大(da)解(jie)决(jue)我(wo)国儿科肝肾移(yi)植患者未满足的临床需(xu)求。

罕见病药物:

23.注射用拉(la)罗尼酶浓溶液,为国(guo)(guo)(guo)内(nei)(nei)首(shou)个用于罕见(jian)病黏多糖贮积症I型(xing)(MPS I,α-L-艾杜糖苷(gan)酶缺乏症)的酶替代治疗(liao)(liao)药(yao)物,属临床急需境外新(xin)药(yao)名单品(pin)种。黏多糖贮积症I型(xing)是(shi)一种严重危及(ji)生命且国(guo)(guo)(guo)内(nei)(nei)尚无(wu)有(you)效治疗(liao)(liao)手段的遗传性罕见(jian)病,已列入我国(guo)(guo)(guo)第一批(pi)罕见(jian)病目录,本(ben)品(pin)获批(pi)上市(shi)填补了(le)我国(guo)(guo)(guo)此类患者(zhe)的用药(yao)空(kong)白(bai)。

24.艾(ai)度硫酸酯酶(mei)β注射液(ye),为国(guo)内首个用(yong)(yong)于罕见病(bing)黏(nian)多糖贮积(ji)症Ⅱ型(MPS Ⅱ,亨特综合(he)征)的(de)(de)酶(mei)替代治(zhi)疗(liao)药(yao)物。黏(nian)多糖贮积(ji)症Ⅱ型是一(yi)种严重危及生命且国(guo)内尚无有效治(zhi)疗(liao)手段的(de)(de)遗传性罕见病(bing),已(yi)列入我国(guo)第一(yi)批罕见病(bing)目录,本品获批上(shang)市填补(bu)了(le)我国(guo)此类(lei)患者的(de)(de)用(yong)(yong)药(yao)空白(bai)。

体(ti)内诊断试剂:

25.重组结(jie)核杆菌(jun)(jun)(jun)融合蛋(dan)白(EC),适用(yong)(yong)于6月龄及以(yi)上(shang)婴儿(er)、儿(er)童及65周岁(sui)以(yi)下成人结(jie)核杆菌(jun)(jun)(jun)感(gan)染(ran)(ran)诊断(duan),并(bing)可用(yong)(yong)于辅助结(jie)核病的临(lin)床(chuang)诊断(duan),为全球首个用(yong)(yong)于鉴别卡介苗接种与结(jie)核杆菌(jun)(jun)(jun)感(gan)染(ran)(ran)的体内诊断(duan)产品(pin),其获批上(shang)市为临(lin)床(chuang)鉴别诊断(duan)提供了(le)新的手段。

预(yu)防用生(sheng)物制品(疫(yi)苗):

26.鼻喷冻干流(liu)感(gan)减(jian)毒(du)活疫(yi)苗(miao):为国内(nei)首家以鼻喷途径接(jie)种(zhong)的疫(yi)苗(miao),适用于(yu)3(36月龄)~17岁人群(qun)用于(yu)预防(fang)由疫(yi)苗(miao)相(xiang)关型别的流(liu)感(gan)病毒(du)引起的流(liu)行性(xing)感(gan)冒,接(jie)种(zhong)后可刺激机体(ti)产(chan)生(sheng)抗流(liu)感(gan)病毒(du)的免疫(yi)力。

中药(yao)新药(yao):

27.桑(sang)枝(zhi)总生(sheng)(sheng)物碱片,其(qi)主要成分为桑(sang)枝(zhi)中提(ti)取得到的桑(sang)枝(zhi)总生(sheng)(sheng)物碱,是近(jin)10年来首个获(huo)批上(shang)市(shi)的抗糖(tang)(tang)尿病(bing)中药新药,适用于配合(he)饮食控制及运动、治疗2型(xing)糖(tang)(tang)尿病(bing)。本(ben)品可有效(xiao)降(jiang)低2型(xing)糖(tang)(tang)尿病(bing)受(shou)试者糖(tang)(tang)化血红(hong)蛋白(bai)水(shui)平,其(qi)获(huo)批上(shang)市(shi)为2型(xing)糖(tang)(tang)尿病(bing)患(huan)者提(ti)供新的治疗选择(ze)。

28.筋骨止痛(tong)凝(ning)胶,为醋延胡(hu)索、川芎等12种药味组成的(de)(de)中药复(fu)方(fang)新(xin)(xin)药,适用于(yu)膝骨关(guan)(guan)节(jie)炎(yan)(yan)肾虚筋脉瘀(yu)滞证(zheng)的(de)(de)症状改善,具有“活(huo)血理(li)气,祛风(feng)除(chu)湿(shi),通络止痛(tong)”的(de)(de)功效。本品为外用凝(ning)胶制剂,药物(wu)中各成分通过(guo)透皮(pi)吸收而发挥作用,可(ke)避免肠胃(wei)吸收和肝(gan)脏首过(guo)代谢,其获批上市可(ke)为膝关(guan)(guan)节(jie)骨性(xing)关(guan)(guan)节(jie)炎(yan)(yan)患者提(ti)供新(xin)(xin)的(de)(de)治疗(liao)选择。

29.连花清咳片,为(wei)麻黄、桑白皮等(deng)15种药(yao)味组成(cheng)的中药(yao)新药(yao),适用于治(zhi)(zhi)疗急性(xing)气管-支气管炎(yan)痰热(re)壅肺(fei)证引起的咳嗽、咳痰等(deng),具(ju)有(you)“宣肺(fei)泄热(re),化痰止(zhi)咳”的功效,其获批上(shang)市可为(wei)急性(xing)气管-支气管炎(yan)患者(zhe)提供新的治(zhi)(zhi)疗选择(ze)。

四、全力做(zuo)好应急审评工作

(一(yi))加强统一(yi)领(ling)导(dao),制定工作程序

按照(zhao)(zhao)国(guo)家(jia)(jia)药(yao)(yao)(yao)监(jian)局党(dang)组(zu)关(guan)于疫情防控应(ying)(ying)急(ji)审(shen)(shen)评审(shen)(shen)批工(gong)(gong)作(zuo)(zuo)(zuo)部(bu)署,药(yao)(yao)(yao)审(shen)(shen)中(zhong)心(xin)闻令而(er)动,一是(shi)充分发(fa)挥集(ji)体决策作(zuo)(zuo)(zuo)用,迅速成立抗(kang)新(xin)型(xing)冠(guan)(guan)状(zhuang)病(bing)毒(du)(du)药(yao)(yao)(yao)物(wu)特别审(shen)(shen)评领导小(xiao)(xiao)(xiao)(xiao)组(zu),抽调16个部(bu)门148名(ming)骨干力量为工(gong)(gong)作(zuo)(zuo)(zuo)小(xiao)(xiao)(xiao)(xiao)组(zu)成员,先后召开特别审(shen)(shen)评领导小(xiao)(xiao)(xiao)(xiao)组(zu)会议(yi)6次(ci)和领导小(xiao)(xiao)(xiao)(xiao)组(zu)专题(ti)会18次(ci),明晰工(gong)(gong)作(zuo)(zuo)(zuo)原(yuan)则(ze),优化(hua)工(gong)(gong)作(zuo)(zuo)(zuo)流(liu)程(cheng)(cheng),及时研究解决应(ying)(ying)急(ji)审(shen)(shen)评过程(cheng)(cheng)中(zhong)遇到的问(wen)题(ti),保证工(gong)(gong)作(zuo)(zuo)(zuo)顺(shun)利推进、有序开展。二是(shi)制(zhi)定(ding)工(gong)(gong)作(zuo)(zuo)(zuo)程(cheng)(cheng)序,形成1个方(fang)案、2个程(cheng)(cheng)序、1个规范(fan),即《药(yao)(yao)(yao)审(shen)(shen)中(zhong)心(xin)抗(kang)新(xin)型(xing)冠(guan)(guan)状(zhuang)病(bing)毒(du)(du)药(yao)(yao)(yao)物(wu)特别审(shen)(shen)评工(gong)(gong)作(zuo)(zuo)(zuo)方(fang)案》《关(guan)于新(xin)型(xing)冠(guan)(guan)状(zhuang)病(bing)毒(du)(du)(2019-nCoV)药(yao)(yao)(yao)物(wu)立项(xiang)申请评议(yi)工(gong)(gong)作(zuo)(zuo)(zuo)程(cheng)(cheng)序》《关(guan)于新(xin)型(xing)冠(guan)(guan)状(zhuang)病(bing)毒(du)(du)(2019-nCoV)药(yao)(yao)(yao)物(wu)特别专家(jia)(jia)组(zu)评估(gu)和审(shen)(shen)核工(gong)(gong)作(zuo)(zuo)(zuo)程(cheng)(cheng)序》《国(guo)家(jia)(jia)药(yao)(yao)(yao)监(jian)局抗(kang)新(xin)型(xing)冠(guan)(guan)状(zhuang)病(bing)毒(du)(du)药(yao)(yao)(yao)物(wu)专家(jia)(jia)会议(yi)管理规范(fan)》。三是(shi)严格落(luo)实“安全守底(di)线(xian)、疗效有证据、质量能保证、审(shen)(shen)评超常规”的工(gong)(gong)作(zuo)(zuo)(zuo)要求,按照(zhao)(zhao)工(gong)(gong)作(zuo)(zuo)(zuo)程(cheng)(cheng)序,依法依规、科学规范(fan)审(shen)(shen)评,标准不降(jiang),加速审(shen)(shen)批。

(二)发挥专家作用(yong),解决技术难题

一(yi)是(shi)组建(jian)特别(bie)专(zhuan)家(jia)(jia)组。按照《国家(jia)(jia)食品药(yao)品监(jian)(jian)(jian)督(du)管(guan)理局(ju)药(yao)品特别(bie)审批程(cheng)序》(原(yuan)国家(jia)(jia)食品药(yao)品监(jian)(jian)(jian)督(du)管(guan)理局(ju)令第21号(hao))规定和(he)(he)国家(jia)(jia)药(yao)监(jian)(jian)(jian)局(ju)新型冠状病毒(du)感染肺炎(yan)疫情应对工(gong)作(zuo)组药(yao)品组的(de)(de)(de)决定,药(yao)审中心先(xian)后(hou)遴选出多位院士(shi)和(he)(he)知名专(zhuan)家(jia)(jia)组成(cheng)了(le)特别(bie)专(zhuan)家(jia)(jia)组,经国家(jia)(jia)药(yao)监(jian)(jian)(jian)局(ju)批准后(hou)开展工(gong)作(zuo)。遇到新的(de)(de)(de)技术(shu)(shu)难点问题(ti)时,听取(qu)专(zhuan)家(jia)(jia)意见(jian)建(jian)议(yi)后(hou),由专(zhuan)家(jia)(jia)投票表决。二是(shi)注重发(fa)(fa)挥专(zhuan)家(jia)(jia)技术(shu)(shu)支撑(cheng)作(zuo)用。通(tong)过(guo)专(zhuan)家(jia)(jia)研讨会和(he)(he)专(zhuan)家(jia)(jia)咨询会解决特定技术(shu)(shu)问题(ti),例(li)如针对mRNA新冠病毒(du)疫苗在研发(fa)(fa)上存在的(de)(de)(de)难点和(he)(he)潜在的(de)(de)(de)风险,药(yao)审中心组织专(zhuan)家(jia)(jia)形成(cheng)技术(shu)(shu)指(zhi)导(dao)原(yuan)则,以指(zhi)导(dao)相关(guan)企业的(de)(de)(de)研发(fa)(fa)。

(三(san))实时(shi)高(gao)效(xiao)沟通,提高(gao)研(yan)发(fa)进度(du)

一(yi)是(shi)遵循“早(zao)期(qi)介入、持续跟进(jin)、主动(dong)服务”的(de)(de)(de)工(gong)作要求,第一(yi)时间(jian)组(zu)(zu)织审评(ping)力量对咨(zi)询品(pin)种或(huo)注册(ce)申(shen)请立项(xiang)的(de)(de)(de)科学性(xing)(xing)和(he)可行性(xing)(xing)进(jin)行评(ping)议,并在(zai)24小时内(nei)与申(shen)请人进(jin)行沟(gou)通(tong)交(jiao)流,保证申(shen)请人尽快提交(jiao)特(te)别审批注册(ce)申(shen)请。二(er)是(shi)加强国(guo)际(ji)合作。积极(ji)参加世(shi)界卫(wei)生(sheng)组(zu)(zu)织(WHO)、国(guo)际(ji)药品(pin)监(jian)管机构联盟(ICMRA)等组(zu)(zu)织召开(kai)的(de)(de)(de)视(shi)频电话(hua)会(hui)议,共(gong)同探(tan)讨研(yan)发(fa)审评(ping)标准,了解(jie)新冠病毒疫(yi)苗研(yan)发(fa)信(xin)息,指导推(tui)动(dong)研(yan)发(fa)企业赴国(guo)外开(kai)展Ⅲ期(qi)临(lin)床试(shi)验。

(四)探索研审联动,坚持科学审评

一是探索建(jian)立研发(fa)审(shen)评联动工作(zuo)机制(zhi)(zhi)。边研发(fa)、边提交(jiao)、边审(shen)评,为(wei)新冠(guan)(guan)病(bing)毒(du)疫苗研发(fa)争取到了宝贵时(shi)(shi)间(jian),确保新冠(guan)(guan)病(bing)毒(du)疫苗等研发(fa)走在世界(jie)前(qian)列。通过这种工作(zuo)机制(zhi)(zhi),大大缩短了审(shen)评时(shi)(shi)间(jian)。二是建(jian)立技(ji)术(shu)标(biao)(biao)准体(ti)系。针对新冠(guan)(guan)病(bing)毒(du)的特(te)点,及时(shi)(shi)制(zhi)(zhi)定新冠(guan)(guan)病(bing)毒(du)疫苗、新冠(guan)(guan)肺(fei)炎(yan)治疗药物研发(fa)技(ji)术(shu)指(zhi)导原(yuan)则等28个技(ji)术(shu)文(wen)件(jian),指(zhi)导企业(ye)高标(biao)(biao)准研发(fa),少(shao)走弯路,科学(xue)开展(zhan)审(shen)评。

 五、鼓(gu)励中(zhong)药传(chuan)承创新发展

贯彻落实(shi)习近平总书记关于(yu)(yu)(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)的重要(yao)(yao)指(zhi)(zhi)(zhi)示(shi)精(jing)神、《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)共中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)央 国务院关于(yu)(yu)(yu)促(cu)进(jin)(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)传承创(chuang)新(xin)发(fa)展(zhan)(zhan)(zhan)(zhan)的意见》及(ji)国家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监局要(yao)(yao)求(qiu)(qiu)(qiu),药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)审(shen)(shen)(shen)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)心(xin)从改革中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)分(fen)类、健全中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则等(deng)(deng)各方(fang)(fang)(fang)(fang)面积极鼓励中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)守正创(chuang)新(xin)。一是(shi)推动(dong)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)的传承发(fa)展(zhan)(zhan)(zhan)(zhan)。起草并由国家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监局发(fa)布《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)分(fen)类及(ji)申报(bao)资料(liao)要(yao)(yao)求(qiu)(qiu)(qiu)》,丰富古代经典(dian)名方(fang)(fang)(fang)(fang)复方(fang)(fang)(fang)(fang)制(zhi)剂的范(fan)围,促(cu)进(jin)(jin)古代经典(dian)名方(fang)(fang)(fang)(fang)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)(fang)(fang)(fang)制(zhi)剂研(yan)发(fa),推动(dong)其向新(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)转化(hua)(hua)。二是(shi)建(jian)立完善符(fu)合(he)(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)(te)点(dian)(dian)(dian)的质量(liang)控制(zhi)体系。遵循中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)(te)点(dian)(dian)(dian)和(he)(he)研(yan)发(fa)规律(lv),将中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)独特(te)(te)(te)(te)的理论体系和(he)(he)实(shi)践特(te)(te)(te)(te)点(dian)(dian)(dian)、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)剂质量(liang)控制(zhi)特(te)(te)(te)(te)点(dian)(dian)(dian)与药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品质量(liang)控制(zhi)的一般要(yao)(yao)求(qiu)(qiu)(qiu)有(you)机结合(he)(he),研(yan)究构建(jian)完善符(fu)合(he)(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)剂特(te)(te)(te)(te)点(dian)(dian)(dian)的质量(liang)控制(zhi)方(fang)(fang)(fang)(fang)法和(he)(he)策略,制(zhi)定《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)饮片炮制(zhi)研(yan)究指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则(试行(xing)(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质量(liang)标(biao)准(zhun)研(yan)究技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则(试行(xing)(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方(fang)(fang)(fang)(fang)制(zhi)剂生产工(gong)艺(yi)研(yan)究技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则(试行(xing)(xing))》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)生物(wu)效应检测(ce)研(yan)究技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则(试行(xing)(xing))》等(deng)(deng)8个技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则。三(san)是(shi)健全符(fu)合(he)(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)(te)点(dian)(dian)(dian)的审(shen)(shen)(shen)评(ping)(ping)体系。引入新(xin)工(gong)具(ju)、新(xin)方(fang)(fang)(fang)(fang)法、新(xin)标(biao)准(zhun)用(yong)(yong)(yong)于(yu)(yu)(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)疗效评(ping)(ping)价,细化(hua)(hua)申报(bao)资料(liao)要(yao)(yao)求(qiu)(qiu)(qiu),制(zhi)定《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)于(yu)(yu)(yu)慢性便秘临(lin)(lin)床研(yan)究技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则》《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用(yong)(yong)(yong)于(yu)(yu)(yu)糖尿病肾病临(lin)(lin)床研(yan)究技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则》等(deng)(deng)技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则,探索构建(jian)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)理论、人用(yong)(yong)(yong)经验(yan)和(he)(he)临(lin)(lin)床试验(yan)相(xiang)结合(he)(he)的审(shen)(shen)(shen)评(ping)(ping)证(zheng)据体系。四是(shi)全力(li)做好中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)特(te)(te)(te)(te)别审(shen)(shen)(shen)评(ping)(ping)工(gong)作(zuo)(zuo)。充分(fen)发(fa)扬(yang)抗疫精(jing)神,制(zhi)定了《用(yong)(yong)(yong)于(yu)(yu)(yu)新(xin)冠肺(fei)(fei)炎中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)申请特(te)(te)(te)(te)别审(shen)(shen)(shen)批(pi)(pi)申报(bao)资料(liao)要(yao)(yao)求(qiu)(qiu)(qiu)(试行(xing)(xing))》《用(yong)(yong)(yong)于(yu)(yu)(yu)新(xin)冠肺(fei)(fei)炎中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)注(zhu)册(ce)申请特(te)(te)(te)(te)别审(shen)(shen)(shen)批(pi)(pi)技(ji)术指(zhi)(zhi)(zhi)导原(yuan)(yuan)(yuan)则(试行(xing)(xing))》等(deng)(deng),指(zhi)(zhi)(zhi)导应急状(zhuang)态下的中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)审(shen)(shen)(shen)评(ping)(ping)。截至2020年12月31日,“三(san)方(fang)(fang)(fang)(fang)”中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)的清(qing)肺(fei)(fei)排毒颗粒、化(hua)(hua)湿败毒颗粒的IND申请已获批(pi)(pi)准(zhun),“三(san)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)”连花清(qing)瘟颗粒/胶囊(nang)、金花清(qing)感(gan)颗粒、血必净注(zhu)射(she)液获批(pi)(pi)增(zeng)加用(yong)(yong)(yong)于(yu)(yu)(yu)治(zhi)疗新(xin)冠肺(fei)(fei)炎的适应症(zheng)。五是(shi)赴(fu)武汉开(kai)展(zhan)(zhan)(zhan)(zhan)实(shi)地调研(yan)和(he)(he)座谈,持续推进(jin)(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)监管科学“以临(lin)(lin)床价值为导向的中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)安全性评(ping)(ping)价研(yan)究”课题研(yan)究。六是(shi)开(kai)展(zhan)(zhan)(zhan)(zhan)援疆(jiang)援藏(zang)(zang)工(gong)作(zuo)(zuo),赴(fu)西藏(zang)(zang)开(kai)展(zhan)(zhan)(zhan)(zhan)实(shi)地调研(yan)、与新(xin)疆(jiang)维吾尔(er)自治(zhi)区药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品监督管理局召开(kai)线上座谈交(jiao)流(liu)会(hui),支持民族药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)发(fa)展(zhan)(zhan)(zhan)(zhan)。

  六、加强《药(yao)品注(zhu)册管理办法》配套文件制修订

新修(xiu)订(ding)的(de)(de)《药(yao)品(pin)(pin)注(zhu)册(ce)管理(li)办(ban)法》是贯彻(che)党中(zhong)央、国务院审(shen)评审(shen)批制度改革精神和(he)落实(shi)新修(xiu)订(ding)《药(yao)品(pin)(pin)管理(li)法》的(de)(de)重要规章,考(kao)虑到药(yao)品(pin)(pin)注(zhu)册(ce)管理(li)中(zhong)的(de)(de)具(ju)体技(ji)术(shu)(shu)(shu)(shu)要求,需要跟随技(ji)术(shu)(shu)(shu)(shu)发(fa)(fa)(fa)展的(de)(de)脚(jiao)步不断调整完善,在规章中(zhong)不适宜作出具(ju)体的(de)(de)规定,因此这些(xie)具(ju)体技(ji)术(shu)(shu)(shu)(shu)要求在《药(yao)品(pin)(pin)注(zhu)册(ce)管理(li)办(ban)法》发(fa)(fa)(fa)布后,以(yi)配套文件(jian)、技(ji)术(shu)(shu)(shu)(shu)指(zhi)导原则等(deng)形式发(fa)(fa)(fa)布,既能(neng)更好(hao)地顺应药(yao)品(pin)(pin)研发(fa)(fa)(fa)的(de)(de)科学(xue)规律,也能(neng)确保(bao)新旧《药(yao)品(pin)(pin)注(zhu)册(ce)管理(li)办(ban)法》的(de)(de)平稳过渡和(he)新《药(yao)品(pin)(pin)注(zhu)册(ce)管理(li)办(ban)法》的(de)(de)顺利实(shi)施。

根据国家局部署,药审(shen)(shen)中(zhong)心统筹协调(diao),加大配(pei)套(tao)文(wen)件(jian)的制修订(ding)力(li)度,成立课题(ti)(ti)组,对(dui)重点难点问题(ti)(ti)开(kai)展(zhan)调(diao)研(yan)攻关,充分听取专家、业界(jie)意(yi)见(jian),力(li)求达成共识,共参与了48个(ge)配(pei)套(tao)文(wen)件(jian)制修订(ding)工作,其(qi)中(zhong)牵头起草配(pei)套(tao)文(wen)件(jian)30个(ge)。自(zi)开(kai)展(zhan)工作以(yi)来,已基(ji)本(ben)完成配(pei)套(tao)文(wen)件(jian)公开(kai)征求意(yi)见(jian)工作,部分文(wen)件(jian)已经国家局审(shen)(shen)核同意(yi)后发布实(shi)(shi)施,有效确保了各项审(shen)(shen)评任务不(bu)断、不(bu)散、不(bu)乱,新旧注册相关规(gui)定(ding)的顺利过渡(du)和实(shi)(shi)施。

 七、加快审评(ping)技术标准体系建设

在药品审(shen)评和(he)研发过程(cheng)(cheng)中(zhong),指导原则(ze)(ze)兼具监管依据和(he)技术要求的双重职能(neng)。《药品注册管理(li)(li)办(ban)法(fa)》明确从事(shi)药物研制和(he)药品注册活动,应(ying)当(dang)遵守有(you)关法(fa)律、法(fa)规(gui)、规(gui)章、标(biao)准(zhun)和(he)规(gui)范(fan);药审(shen)中(zhong)心等专业技术机(ji)构,应(ying)当(dang)根(gen)据科学进展、行(xing)业发展实(shi)际和(he)药品监督管理(li)(li)工作需(xu)要制定(ding)技术指导原则(ze)(ze)和(he)程(cheng)(cheng)序(xu),并(bing)向社会公布。

药(yao)品技(ji)术指(zhi)(zhi)导(dao)(dao)原则(ze)(ze)(ze)(ze)体系(xi)(xi)的建(jian)立与完善(shan),是落实“四个(ge)最严”要(yao)求(qiu)的最好(hao)实践,是药(yao)审中(zhong)心(xin)推进审评体系(xi)(xi)和审评能力现代化的重要(yao)举措。药(yao)审中(zhong)心(xin)通(tong)过“定标(biao)准、定程(cheng)序、定计划”三步走的方式,统筹(chou)规(gui)划以指(zhi)(zhi)导(dao)(dao)原则(ze)(ze)(ze)(ze)为(wei)核(he)心(xin)的审评标(biao)准体系(xi)(xi)建(jian)设,围绕(rao)药(yao)品研(yan)发需求(qiu)和鼓励创新的原则(ze)(ze)(ze)(ze),对标(biao)国际(ji)先进监(jian)管机构技(ji)术标(biao)准,加(jia)大指(zhi)(zhi)导(dao)(dao)原则(ze)(ze)(ze)(ze)制定和公开力度。2020年共开展了119个(ge)技(ji)术指(zhi)(zhi)导(dao)(dao)原则(ze)(ze)(ze)(ze)制修订工作,根据《国家(jia)药(yao)监(jian)局综合司关于(yu)印(yin)发药(yao)品技(ji)术指(zhi)(zhi)导(dao)(dao)原则(ze)(ze)(ze)(ze)发布程(cheng)序的通(tong)知(zhi)》(药(yao)监(jian)综药(yao)管〔2020〕9号)要(yao)求(qiu),截(jie)至2020年12月31日(ri),药(yao)审中(zhong)心(xin)已经国家(jia)药(yao)监(jian)局审查同意发布了71个(ge)指(zhi)(zhi)导(dao)(dao)原则(ze)(ze)(ze)(ze),详见附件6。

在(zai)应对新型冠(guan)状病(bing)毒(du)肺炎、促进(jin)新冠(guan)病(bing)毒(du)疫苗和新冠(guan)肺炎治疗药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)的(de)研(yan)(yan)发(fa)(fa)(fa)和审(shen)(shen)评(ping)(ping)(ping)(ping)质(zhi)量(liang)(liang)、速度方面(mian),药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)审(shen)(shen)中(zhong)心发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《新型冠(guan)状病(bing)毒(du)预防(fang)用疫苗研(yan)(yan)发(fa)(fa)(fa)技(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)(试(shi)(shi)(shi)行(xing))》等(deng)(deng)7个(ge)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze);在(zai)着力提升中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)材质(zhi)量(liang)(liang)研(yan)(yan)究,鼓(gu)励中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)研(yan)(yan)发(fa)(fa)(fa)与创新方面(mian),发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)材质(zhi)量(liang)(liang)控制研(yan)(yan)究技(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)(试(shi)(shi)(shi)行(xing))》《中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)复方制剂(ji)生(sheng)产工艺(yi)研(yan)(yan)究技(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)(试(shi)(shi)(shi)行(xing))》《中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)新药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)用于(yu)慢性(xing)便(bian)秘(mi)临(lin)床研(yan)(yan)究技(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)》等(deng)(deng)10个(ge)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze);在(zai)鼓(gu)励儿童药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa)方面(mian),发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《真实世界研(yan)(yan)究支持(chi)儿童药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa)与审(shen)(shen)评(ping)(ping)(ping)(ping)的(de)技(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)(试(shi)(shi)(shi)行(xing))》等(deng)(deng)3个(ge)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze);在(zai)支持(chi)抗肿瘤(liu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa),进(jin)一步(bu)满足申(shen)请(qing)人对具体(ti)抗肿瘤(liu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)的(de)个(ge)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)需求方面(mian),发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《抗肿瘤(liu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)联合治疗临(lin)床试(shi)(shi)(shi)验技(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)》《注(zhu)射(she)用曲(qu)妥珠(zhu)单(dan)抗生(sheng)物(wu)(wu)(wu)类似药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)临(lin)床试(shi)(shi)(shi)验指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)》等(deng)(deng)22个(ge)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze);在(zai)提高仿制药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)量(liang)(liang),推进(jin)仿制药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)一致(zhi)(zhi)性(xing)评(ping)(ping)(ping)(ping)价方面(mian),规范审(shen)(shen)评(ping)(ping)(ping)(ping)标准和尺度,发(fa)(fa)(fa)布(bu)(bu)了(le)(le)《化(hua)学(xue)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品注(zhu)射(she)剂(ji)仿制药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)量(liang)(liang)和疗效一致(zhi)(zhi)性(xing)评(ping)(ping)(ping)(ping)价技(ji)术(shu)(shu)要(yao)求》《化(hua)学(xue)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品注(zhu)射(she)剂(ji)(特(te)殊注(zhu)射(she)剂(ji))仿制药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)质(zhi)量(liang)(liang)和疗效一致(zhi)(zhi)性(xing)评(ping)(ping)(ping)(ping)价技(ji)术(shu)(shu)要(yao)求》等(deng)(deng)9个(ge)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)。这些指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)覆盖(gai)新冠(guan)应急审(shen)(shen)评(ping)(ping)(ping)(ping)标准、儿童用药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)、中(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)民(min)族药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)技(ji)术(shu)(shu)标准体(ti)系、抗肿瘤(liu)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa)及仿制药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)研(yan)(yan)发(fa)(fa)(fa)等(deng)(deng)热(re)点难(nan)点问题(ti),持(chi)续完善药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品技(ji)术(shu)(shu)指(zhi)(zhi)(zhi)导(dao)(dao)(dao)(dao)原(yuan)(yuan)(yuan)则(ze)(ze)(ze)(ze)(ze)体(ti)系,有(you)效推动药(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)发(fa)(fa)(fa)创新,不断优化(hua)统一审(shen)(shen)评(ping)(ping)(ping)(ping)尺度,大力提升审(shen)(shen)评(ping)(ping)(ping)(ping)质(zhi)量(liang)(liang)和效率,显著减少审(shen)(shen)评(ping)(ping)(ping)(ping)自由裁量(liang)(liang)权。

 八、持续深化药(yao)品审(shen)评审(shen)批(pi)制度改革(ge)

(一)加快境外已上市(shi)临床急需新药审评

深入贯彻国(guo)务(wu)院常务(wu)会议精神,落实加快境外(wai)已上(shang)市(shi)临床急需新药(yao)(yao)(yao)审(shen)(shen)评要求(qiu),在(zai)确定了(le)第(di)(di)一二批74个(ge)品(pin)种(zhong)名单(dan)的基础上(shang),国(guo)家(jia)(jia)药(yao)(yao)(yao)监(jian)局、国(guo)家(jia)(jia)卫(wei)(wei)生健康委组(zu)织有关(guan)专家(jia)(jia)研究论(lun)证(zheng),遴选(xuan)临床急需新药(yao)(yao)(yao)品(pin)种(zhong),药(yao)(yao)(yao)审(shen)(shen)中(zhong)心发布了(le)第(di)(di)三批7个(ge)品(pin)种(zhong)名单(dan)。对于(yu)符(fu)合(he)《国(guo)家(jia)(jia)药(yao)(yao)(yao)品(pin)监(jian)督管理局 国(guo)家(jia)(jia)卫(wei)(wei)生健康委员会关(guan)于(yu)临床急需境外(wai)新药(yao)(yao)(yao)审(shen)(shen)评审(shen)(shen)批相关(guan)事(shi)宜(yi)的公(gong)告》(2018年第(di)(di)79号(hao))规定情形的品(pin)种(zhong),国(guo)家(jia)(jia)药(yao)(yao)(yao)监(jian)局会同(tong)国(guo)家(jia)(jia)卫(wei)(wei)生健康委已组(zu)织进行了(le)充分遴选(xuan),基本解决了(le)临床急需境外(wai)已上(shang)市(shi)新药(yao)(yao)(yao)在(zai)我国(guo)上(shang)市(shi)速度较(jiao)慢的问题,进一步(bu)提高了(le)公(gong)众(zhong)用药(yao)(yao)(yao)的可及(ji)性。

2020年,药(yao)(yao)(yao)审(shen)(shen)中心完(wan)成了13个(ge)(ge)用(yong)于治疗罕(han)见(jian)病的(de)(de)、临(lin)(lin)床(chuang)急(ji)(ji)(ji)需的(de)(de)药(yao)(yao)(yao)品(pin)(pin)的(de)(de)技术(shu)审(shen)(shen)评(ping),均在(zai)规(gui)定时(shi)限内(nei)完(wan)成,罕(han)见(jian)病药(yao)(yao)(yao)品(pin)(pin)在(zai)3个(ge)(ge)月之(zhi)内(nei)完(wan)成审(shen)(shen)评(ping),其(qi)(qi)他临(lin)(lin)床(chuang)急(ji)(ji)(ji)需药(yao)(yao)(yao)品(pin)(pin)在(zai)6个(ge)(ge)月之(zhi)内(nei)完(wan)成审(shen)(shen)评(ping),大大缩短(duan)了临(lin)(lin)床(chuang)急(ji)(ji)(ji)需境外(wai)新药(yao)(yao)(yao)在(zai)我(wo)国上市(shi)的(de)(de)时(shi)间差距。截(jie)至2020年12月31日,已(yi)发(fa)布的(de)(de)三批81个(ge)(ge)品(pin)(pin)种临(lin)(lin)床(chuang)急(ji)(ji)(ji)需境外(wai)已(yi)上市(shi)新药(yao)(yao)(yao)中,已(yi)有38家企(qi)业的(de)(de)48个(ge)(ge)品(pin)(pin)种提出(chu)注(zhu)册申请,其(qi)(qi)中39个(ge)(ge)品(pin)(pin)种已(yi)获(huo)批上市(shi)或(huo)完(wan)成审(shen)(shen)评(ping),100%在(zai)时(shi)限内(nei)完(wan)成审(shen)(shen)评(ping)工作,详见(jian)附件7。

(二)加(jia)速推动仿制(zhi)药(yao)一(yi)致性评价工作

2020年,药审中心(xin)采取切实有(you)效措(cuo)施加速推进(jin)仿制药一致性评(ping)价工(gong)作。

一(yi)(yi)是在口服(fu)固体(ti)制(zhi)(zhi)剂(ji)(ji)(ji)一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)工(gong)作(zuo)的(de)基础上,积极推进注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji)一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)工(gong)作(zuo)。国(guo)家药(yao)(yao)(yao)监局(ju)于5月12日发布(bu)(bu)《关于开展(zhan)化学(xue)(xue)药(yao)(yao)(yao)品(pin)注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji)仿制(zhi)(zhi)药(yao)(yao)(yao)质(zhi)量(liang)和(he)疗效一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)工(gong)作(zuo)的(de)公告》(2020年第62号),正式(shi)启动注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji)一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)工(gong)作(zuo)。药(yao)(yao)(yao)审(shen)(shen)中心(xin)发布(bu)(bu)《化学(xue)(xue)药(yao)(yao)(yao)品(pin)注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji)仿制(zhi)(zhi)药(yao)(yao)(yao)质(zhi)量(liang)和(he)疗效一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)技术要求(qiu)》《化学(xue)(xue)药(yao)(yao)(yao)品(pin)注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji)仿制(zhi)(zhi)药(yao)(yao)(yao)质(zhi)量(liang)和(he)疗效一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)申报(bao)资料要求(qiu)》和(he)《化学(xue)(xue)药(yao)(yao)(yao)品(pin)注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji)(特殊注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji))仿制(zhi)(zhi)药(yao)(yao)(yao)质(zhi)量(liang)和(he)疗效一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)技术要求(qiu)》等技术要求(qiu)。针对正式(shi)启动前已(yi)(yi)有(you)620件待审(shen)(shen)评(ping)(ping)(ping)(ping)(ping)的(de)注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji)一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)申请,药(yao)(yao)(yao)审(shen)(shen)中心(xin)成立(li)专项(xiang)审(shen)(shen)评(ping)(ping)(ping)(ping)(ping)工(gong)作(zuo)组,采取细化分类处(chu)理(li)措施,严格执行一(yi)(yi)次性(xing)发补(bu),明确注(zhu)(zhu)(zhu)射(she)(she)(she)(she)(she)剂(ji)(ji)(ji)一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)注(zhu)(zhu)(zhu)册检(jian)查的(de)随机原(yuan)则,加快审(shen)(shen)评(ping)(ping)(ping)(ping)(ping)速度,在不(bu)到5个月的(de)时间(jian)内完成了620件品(pin)种的(de)审(shen)(shen)评(ping)(ping)(ping)(ping)(ping),一(yi)(yi)致(zhi)性(xing)评(ping)(ping)(ping)(ping)(ping)价(jia)按(an)时限审(shen)(shen)评(ping)(ping)(ping)(ping)(ping)已(yi)(yi)进入常态化。

二是继(ji)续规(gui)范参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)遴选(xuan)(xuan)工(gong)作,强化(hua)服(fu)务(wu)与指(zhi)导(dao)。药审中心发(fa)布《化(hua)学(xue)仿(fang)制(zhi)(zhi)药参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)遴选(xuan)(xuan)申请(qing)(qing)资料要求》(药审中心通(tong)告2020年第32号),进一步强调申请(qing)(qing)人的自查环节,提高参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)遴选(xuan)(xuan)工(gong)作效率。通(tong)过进一步规(gui)范内部审核、专家(jia)委员会审核等流程,2020年优化(hua)了参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)遴选(xuan)(xuan)工(gong)作。自2017年8月开展一致(zhi)性评(ping)价(jia)工(gong)作以来共发(fa)布参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)目录35批(pi),涉及(ji)3963个(ge)(ge)品(pin)规(gui)(1703个(ge)(ge)品(pin)种),其中包括注射(she)剂(ji)(ji)参(can)比(bi)制(zhi)(zhi)剂(ji)(ji)975个(ge)(ge)品(pin)规(gui)(405个(ge)(ge)品(pin)种)。

三是加强信息公开和培训。2020年7月举办(ban)线上化(hua)学仿制(zhi)药(yao)注(zhu)射剂(ji)一(yi)致性评(ping)(ping)价技(ji)术研讨会,对注(zhu)射剂(ji)一(yi)致性评(ping)(ping)价技(ji)术要(yao)求(qiu)、特(te)殊(shu)注(zhu)射剂(ji)技(ji)术要(yao)求(qiu)、参比(bi)制(zhi)剂(ji)申(shen)请资料要(yao)求(qiu)等进行宣讲。

四(si)是持(chi)续推(tui)进生物等效性试验(yan)备案工作。2020年化学药生物等效性试验(yan)备案平(ping)台共收集了672条记录(lu),仿制药一致性评价(jia)生物等效性试验(yan)备案平(ping)台共收集了292条记录(lu)。

(三)全面(mian)落实临床(chuang)试验期(qi)间风险管理

为落实《药(yao)(yao)品(pin)管理(li)法(fa)》《药(yao)(yao)品(pin)注册(ce)管理(li)办(ban)法(fa)》中(zhong)有关临床试(shi)(shi)(shi)验期间(jian)(jian)安(an)全(quan)风(feng)险(xian)(xian)管理(li)工作,药(yao)(yao)审(shen)中(zhong)心(xin)在国家药(yao)(yao)监局(ju)指(zhi)导下,发(fa)布了(le)(le)《药(yao)(yao)物(wu)(wu)临床试(shi)(shi)(shi)验期间(jian)(jian)安(an)全(quan)信(xin)息(xi)评(ping)(ping)估(gu)(gu)与管理(li)规(gui)范(试(shi)(shi)(shi)行(xing)(xing))》、《研(yan)发(fa)期间(jian)(jian)安(an)全(quan)性更新报告管理(li)规(gui)范(试(shi)(shi)(shi)行(xing)(xing))》和《药(yao)(yao)物(wu)(wu)临床试(shi)(shi)(shi)验登记(ji)及信(xin)息(xi)公示(shi)管理(li)规(gui)范(试(shi)(shi)(shi)行(xing)(xing))》3个配套文件。为进一步加强临床试(shi)(shi)(shi)验过程的安(an)全(quan)信(xin)息(xi)监测、识(shi)别、评(ping)(ping)估(gu)(gu)和风(feng)险(xian)(xian)控制,制定(ding)了(le)(le)《药(yao)(yao)品(pin)审(shen)评(ping)(ping)中(zhong)心(xin)药(yao)(yao)物(wu)(wu)临床试(shi)(shi)(shi)验期间(jian)(jian)安(an)全(quan)信(xin)息(xi)评(ping)(ping)估(gu)(gu)与风(feng)险(xian)(xian)管理(li)工作程序(试(shi)(shi)(shi)行(xing)(xing))》,上线(xian)运行(xing)(xing)“临床试(shi)(shi)(shi)验期间(jian)(jian)安(an)全(quan)风(feng)险(xian)(xian)管理(li)系(xi)统”,对(dui)临床试(shi)(shi)(shi)验期间(jian)(jian)的安(an)全(quan)信(xin)息(xi),如可疑且非预(yu)期严(yan)重(zhong)不良反(fan)应(SUSAR)和研(yan)发(fa)期间(jian)(jian)安(an)全(quan)性更新报告(DSUR)等(deng)开展(zhan)全(quan)过程信(xin)息(xi)系(xi)统化的风(feng)险(xian)(xian)评(ping)(ping)估(gu)(gu)。

2020年(nian)药审中(zhong)心接收来自国内外的(de)SUSAR个(ge)例报告164403份(fen)(涉及病例为(wei)57995例)。其中(zhong),来自中(zhong)国的(de)SUSAR个(ge)例报告17243份(fen)(涉及病例为(wei)4647例);接收DSUR共(gong)计1775份(fen);完成(cheng)临床试验登记2610项(含新冠(guan)病毒疫苗(miao)和新冠(guan)肺(fei)炎治(zhi)疗药物)。对(dui)18个(ge)药物临床试验中(zhong)存(cun)在的(de)安(an)全性风险(xian)(xian),提出(chu)了进一步的(de)风险(xian)(xian)控制处理意见,包括一般风险(xian)(xian)控制(如修(xiu)改临床试验方(fang)案、修(xiu)改知情同意书、修(xiu)改研(yan)究者手册、补充完善风险(xian)(xian)控制措施(shi))和建议申请人(ren)主(zhu)动暂停临床试验等。

面对突如其来(lai)的(de)(de)严重新冠(guan)肺(fei)炎疫情,药(yao)审中心(xin)探索建立了(le)申请(qing)人进(jin)行(xing)临(lin)床(chuang)(chuang)(chuang)试(shi)验进(jin)展信息报告(gao)机(ji)制(zhi)与(yu)通道(dao),规范了(le)相关工作程序与(yu)技术要求,发布了(le)《新冠(guan)肺(fei)炎疫情期间药(yao)物(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)验管理指导原则(试(shi)行(xing))》,制(zhi)定(ding)了(le)规范统一的(de)(de)《应(ying)急(ji)(ji)审批品(pin)种(zhong)临(lin)床(chuang)(chuang)(chuang)试(shi)验进(jin)展和安(an)全监(jian)测(ce)工作文(wen)件》。通过每(mei)日和每(mei)周的(de)(de)动态(tai)风险沟通交流,实施有(you)效的(de)(de)风险监(jian)测(ce)与(yu)风险控制(zhi)。对2020年(nian)2月2日至2020年(nian)12月31日经特别审批程序批准15个(ge)(ge)疫苗(miao)、16个(ge)(ge)生物(wu)制(zhi)品(pin)、6个(ge)(ge)化学药(yao)、2个(ge)(ge)中药(yao)的(de)(de)临(lin)床(chuang)(chuang)(chuang)试(shi)验共(gong)(gong)39个(ge)(ge)品(pin)种(zhong)实施动态(tai)安(an)全监(jian)测(ce),完成(cheng)了(le)应(ying)急(ji)(ji)审批新冠(guan)病(bing)毒疫苗(miao)及(ji)新冠(guan)肺(fei)炎治(zhi)疗药(yao)物(wu)临(lin)床(chuang)(chuang)(chuang)试(shi)验进(jin)展及(ji)安(an)全性监(jian)测(ce)报告(gao)共(gong)(gong)195份。

药(yao)审中(zhong)心参加《药(yao)物(wu)警(jing)戒(jie)质量管(guan)理(li)规范》(GVP)的(de)起草工作(zuo),撰写临(lin)床试验(yan)期(qi)间(jian)药(yao)物(wu)警(jing)戒(jie)相关(guan)内容和要求。完成《临(lin)床试验(yan)期(qi)间(jian)安(an)全信息管(guan)理(li):国际医学科学组织理(li)事会(hui)(CIOMS)VI工作(zuo)组报告(gao)》的(de)翻(fan)译(yi)与出版工作(zuo),召开“疫情期(qi)间(jian)临(lin)床试验(yan)管(guan)理(li)及远程智能(neng)技术应(ying)用学术交(jiao)流(liu)视(shi)频会(hui)议”,探索开展远程智能(neng)化临(lin)床试验(yan)的(de)安(an)全管(guan)理(li)工作(zuo),稳步提升(sheng)临(lin)床试验(yan)期(qi)间(jian)安(an)全信息评估和风险管(guan)理(li)能(neng)力。

(四(si))继续夯实审评科(ke)学(xue)基(ji)础建设(she)

1.审评质量管理体系建设

发(fa)挥审(shen)(shen)评(ping)质(zhi)量(liang)管理体(ti)(ti)系(xi)对(dui)药(yao)(yao)(yao)品审(shen)(shen)评(ping)工(gong)(gong)(gong)作(zuo)(zuo)持续有效(xiao)运行的保障作(zuo)(zuo)用。一(yi)方面是应对(dui)新法律规章(zhang)实施对(dui)审(shen)(shen)评(ping)业务(wu)工(gong)(gong)(gong)作(zuo)(zuo)带(dai)来(lai)的风(feng)险(xian)和挑战,结(jie)合《药(yao)(yao)(yao)品注(zhu)册管理办(ban)法》及其(qi)配(pei)套(tao)文件(jian)要求,及时组(zu)织对(dui)《质(zhi)量(liang)手册》等体(ti)(ti)系(xi)文件(jian)进行全面修(xiu)订,加强药(yao)(yao)(yao)品审(shen)(shen)评(ping)业务(wu)与(yu)质(zhi)量(liang)体(ti)(ti)系(xi)的结(jie)合;另一(yi)方面是应对(dui)新冠肺炎疫(yi)情(qing)对(dui)审(shen)(shen)评(ping)工(gong)(gong)(gong)作(zuo)(zuo)带(dai)来(lai)的影响,通过开(kai)展药(yao)(yao)(yao)审(shen)(shen)中(zhong)(zhong)心(xin)专项内(nei)部监(jian)督检查,充分锻炼药(yao)(yao)(yao)审(shen)(shen)中(zhong)(zhong)心(xin)内(nei)审(shen)(shen)员队(dui)伍(wu),及时发(fa)现存在(zai)的风(feng)险(xian)并组(zu)织改进;同(tong)时持续开(kai)展年(nian)度满意(yi)度调查工(gong)(gong)(gong)作(zuo)(zuo),收集国(guo)家(jia)药(yao)(yao)(yao)监(jian)局(ju)和申(shen)请(qing)人对(dui)药(yao)(yao)(yao)审(shen)(shen)中(zhong)(zhong)心(xin)在(zai)落实新注(zhu)册相关(guan)要求、应对(dui)新冠肺炎疫(yi)情(qing)风(feng)险(xian)防(fang)控时的意(yi)见(jian)和建议,为提(ti)高审(shen)(shen)评(ping)质(zhi)量(liang)和效(xiao)率提(ti)供(gong)思路,发(fa)挥质(zhi)量(liang)体(ti)(ti)系(xi)对(dui)各项工(gong)(gong)(gong)作(zuo)(zuo)的支持作(zuo)(zuo)用。

2.强化(hua)审评信(xin)息化(hua)建设

为确保(bao)各项审(shen)(shen)(shen)(shen)评(ping)(ping)改革工(gong)作(zuo)执(zhi)行(xing)过程中的规范化(hua)、标准化(hua)、数字化(hua),药(yao)审(shen)(shen)(shen)(shen)中心大(da)力(li)(li)推进(jin)信息(xi)化(hua)建设,依(yi)据《药(yao)品(pin)(pin)注(zhu)(zhu)册(ce)(ce)管理(li)(li)办法》和流(liu)(liu)程为导向的科学管理(li)(li)体系,以药(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)业(ye)(ye)(ye)务(wu)流(liu)(liu)程为基(ji)础,立足(zu)工(gong)作(zuo)实(shi)(shi)际,对药(yao)品(pin)(pin)技术审(shen)(shen)(shen)(shen)评(ping)(ping)系统(tong)升级完善。新增发补(bu)前的专业(ye)(ye)(ye)审(shen)(shen)(shen)(shen)评(ping)(ping)问询和发补(bu)后(hou)的补(bu)充资料(liao)问询平台,优化(hua)沟通(tong)交流(liu)(liu)系统(tong),加强(qiang)(qiang)审(shen)(shen)(shen)(shen)评(ping)(ping)期间与申(shen)(shen)请(qing)人(ren)的主动(dong)沟通(tong)交流(liu)(liu),促进(jin)审(shen)(shen)(shen)(shen)评(ping)(ping)业(ye)(ye)(ye)务(wu)工(gong)作(zuo)开展;新增异议处理(li)(li)审(shen)(shen)(shen)(shen)核(he)和注(zhu)(zhu)册(ce)(ce)检验网(wang)(wang)(wang)络通(tong)道,调整优先(xian)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批系统(tong),强(qiang)(qiang)化(hua)审(shen)(shen)(shen)(shen)核(he)流(liu)(liu)程可操作(zuo)性(xing),保(bao)障(zhang)(zhang)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批工(gong)作(zuo)顺利实(shi)(shi)施。开通(tong)受理(li)(li)网(wang)(wang)(wang)上预约通(tong)道,减少(shao)人(ren)员流(liu)(liu)动(dong)聚(ju)集(ji),有(you)效(xiao)保(bao)障(zhang)(zhang)新冠肺炎疫情(qing)期间申(shen)(shen)请(qing)人(ren)受理(li)(li)业(ye)(ye)(ye)务(wu)的有(you)序办理(li)(li);增加突(tu)破性(xing)治疗药(yao)物程序,为鼓励创新和加快临床(chuang)急(ji)需品(pin)(pin)种上市(shi)拓宽(kuan)审(shen)(shen)(shen)(shen)评(ping)(ping)通(tong)道。通(tong)过信息(xi)化(hua)手段助(zhu)力(li)(li)药(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批业(ye)(ye)(ye)务(wu)管理(li)(li),强(qiang)(qiang)化(hua)网(wang)(wang)(wang)络信息(xi)安全保(bao)障(zhang)(zhang),不(bu)断(duan)提升药(yao)品(pin)(pin)审(shen)(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)(shen)批工(gong)作(zuo)质量(liang)和效(xiao)率。目前药(yao)审(shen)(shen)(shen)(shen)中心网(wang)(wang)(wang)站申(shen)(shen)请(qing)人(ren)之窗(chuang)实(shi)(shi)名注(zhu)(zhu)册(ce)(ce)申(shen)(shen)请(qing)企业(ye)(ye)(ye)10674家,基(ji)本实(shi)(shi)现了药(yao)品(pin)(pin)、原料(liao)药(yao)、辅料(liao)、包材注(zhu)(zhu)册(ce)(ce)申(shen)(shen)请(qing)人(ren)网(wang)(wang)(wang)上业(ye)(ye)(ye)务(wu)办理(li)(li)的全覆盖。

(五(wu))积极(ji)推进流程导向(xiang)科学管理体(ti)系(xi)建设

为贯彻党的(de)(de)(de)十九届四中(zhong)、五(wu)中(zhong)全(quan)会精神,加强治理体(ti)(ti)系(xi)(xi)(xi)、治理能力建(jian)设(she),以流程(cheng)导向(xiang)科(ke)(ke)学(xue)(xue)管(guan)(guan)(guan)理体(ti)(ti)系(xi)(xi)(xi)建(jian)设(she)为抓(zhua)手,不断推(tui)进药(yao)(yao)品(pin)审(shen)评(ping)(ping)体(ti)(ti)系(xi)(xi)(xi)和(he)审(shen)评(ping)(ping)能力的(de)(de)(de)现代(dai)化(hua)。按照前期(qi)工作计划,药(yao)(yao)审(shen)中(zhong)心已全(quan)面(mian)(mian)铺开(kai)任务受(shou)理、任务分配、专(zhuan)(zhuan)业审(shen)评(ping)(ping)、综合审(shen)评(ping)(ping)、沟(gou)通(tong)交流、专(zhuan)(zhuan)家(jia)咨询(xun)、书面(mian)(mian)发补、核查(cha)检验共8个(ge)子课题(ti)的(de)(de)(de)科(ke)(ke)学(xue)(xue)管(guan)(guan)(guan)理体(ti)(ti)系(xi)(xi)(xi)试(shi)点建(jian)设(she),并(bing)印发《药(yao)(yao)审(shen)中(zhong)心关于(yu)运行(xing)药(yao)(yao)品(pin)专(zhuan)(zhuan)业审(shen)评(ping)(ping)流程(cheng)导向(xiang)科(ke)(ke)学(xue)(xue)管(guan)(guan)(guan)理体(ti)(ti)系(xi)(xi)(xi)有关问题(ti)的(de)(de)(de)通(tong)知》等8个(ge)文件,制定(ding)科(ke)(ke)学(xue)(xue)管(guan)(guan)(guan)理体(ti)(ti)系(xi)(xi)(xi)制度制修(xiu)订计划(含28项(xiang)制度),截至(zhi)2020年12月31日已完成14项(xiang)。注(zhu)重试(shi)点建(jian)设(she)成果的(de)(de)(de)信(xin)息化(hua),将(jiang)各项(xiang)措(cuo)(cuo)施纳入审(shen)评(ping)(ping)信(xin)息系(xi)(xi)(xi)统,增强措(cuo)(cuo)施执行(xing)的(de)(de)(de)刚(gang)性约(yue)束(shu),提高了科(ke)(ke)学(xue)(xue)监管(guan)(guan)(guan)和(he)智慧审(shen)评(ping)(ping)能力。

形(xing)成按(an)季度(du)汇报机制,定期组织(zhi)汇报试(shi)(shi)点(dian)(dian)运(yun)行(xing)情况(kuang)。建(jian)(jian)(jian)立(li)了(le)改革措施(shi)(shi)管理台(tai)账,纳入了(le)58项需(xu)要监(jian)督的(de)(de)改革措施(shi)(shi),按(an)月度(du)对每项改革措施(shi)(shi)实(shi)施(shi)(shi)的(de)(de)责任落实(shi)、进(jin)展情况(kuang)、新问题(ti)和解决建(jian)(jian)(jian)议予以(yi)一(yi)体化(hua)动态管理。召开了(le)试(shi)(shi)点(dian)(dian)推进(jin)座谈(tan)会(hui)、子(zi)课题(ti)结(jie)题(ti)座谈(tan)会(hui),对各子(zi)课题(ti)试(shi)(shi)点(dian)(dian)进(jin)度(du)、成效、问题(ti)等进(jin)行(xing)总结(jie)分析。建(jian)(jian)(jian)立(li)了(le)促进(jin)试(shi)(shi)点(dian)(dian)建(jian)(jian)(jian)设的(de)(de)长效运(yun)行(xing)机制,常态化(hua)、一(yi)体化(hua)推进(jin)科学(xue)审(shen)(shen)评(ping)、高(gao)效审(shen)(shen)评(ping)和廉(lian)洁审(shen)(shen)评(ping)。

(六)持续开展ICH工(gong)作

切实推进我(wo)国(guo)(guo)药(yao)品(pin)审评审批(pi)体系(xi)与(yu)(yu)国(guo)(guo)际(ji)接(jie)轨,参与(yu)(yu)ICH指(zhi)导(dao)(dao)(dao)(dao)原则(ze)(ze)的(de)国(guo)(guo)际(ji)协(xie)调。一是积(ji)极参与(yu)(yu)ICH议(yi)(yi)题协(xie)调工(gong)作(zuo)(zuo),自原国(guo)(guo)家(jia)(jia)食品(pin)药(yao)品(pin)监督管理总局(ju)2017年(nian)加入ICH以(yi)来,已(yi)向(xiang)36个(ge)ICH工(gong)作(zuo)(zuo)组(zu)派出了(le)69名专家(jia)(jia),2020年(nian)参与(yu)(yu)ICH工(gong)作(zuo)(zuo)组(zu)电话会437场。二是进一步推进ICH三(san)级(ji)指(zhi)导(dao)(dao)(dao)(dao)原则(ze)(ze)实施工(gong)作(zuo)(zuo),国(guo)(guo)家(jia)(jia)药(yao)监局(ju)共(gong)发布(bu)了(le)3个(ge)ICH指(zhi)导(dao)(dao)(dao)(dao)原则(ze)(ze)适用及(ji)推荐适用公告。三(san)是组(zu)织开展(zhan)ICH指(zhi)导(dao)(dao)(dao)(dao)原则(ze)(ze)培(pei)训工(gong)作(zuo)(zuo),药(yao)审中(zhong)心(xin)开展(zhan)ICH指(zhi)导(dao)(dao)(dao)(dao)原则(ze)(ze)线上培(pei)训共(gong)15场,主要(yao)(yao)围绕29个(ge)ICH指(zhi)导(dao)(dao)(dao)(dao)原则(ze)(ze)的(de)技术要(yao)(yao)点、实施现(xian)状、实施过程(cheng)中(zhong)可能存在(zai)的(de)问题等(deng)内容进行宣(xuan)贯。培(pei)训对象(xiang)主要(yao)(yao)包括国(guo)(guo)家(jia)(jia)药(yao)监局(ju)相关(guan)司局(ju)、各(ge)直属(shu)单位、各(ge)省级(ji)药(yao)监局(ju)和(he)省级(ji)药(yao)检机构(gou)的(de)相关(guan)工(gong)作(zuo)(zuo)人员(yuan),共(gong)计2723人观看(kan)培(pei)训直播,4244人观看(kan)直播回放。四(si)是召开ICH指(zhi)导(dao)(dao)(dao)(dao)原则(ze)(ze)和(he)协(xie)调议(yi)(yi)题研讨(tao)会,为广泛听取行业(ye)及(ji)学界专家(jia)(jia)意见,2020年(nian)药(yao)审中(zhong)心(xin)共(gong)召开ICH国(guo)(guo)内专家(jia)(jia)研讨(tao)会15场,共(gong)计312人参会。

(七)加强审评队(dui)伍建设和管理

加(jia)强(qiang)(qiang)审(shen)评(ping)队伍建设(she),畅(chang)通(tong)审(shen)评(ping)员职业发展(zhan)通(tong)道,开展(zhan)主(zhu)审(shen)审(shen)评(ping)员认定工(gong)作;完善聘(pin)期(qi)考(kao)核评(ping)价体(ti)系,加(jia)强(qiang)(qiang)员工(gong)聘(pin)期(qi)考(kao)核工(gong)作;开展(zhan)补充性(xing)招聘(pin),引进临床、统计(ji)等紧缺专业人才;加(jia)强(qiang)(qiang)员工(gong)培训,组织(zhi)开展(zhan)《药品注册管理办法》及配套(tao)文件系列讲座(zuo)、实训、英语口(kou)语等培训。

  九、加强(qiang)服务指导、改进(jin)工作效率(lv)和作风

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

一是紧密围绕新(xin)(xin)冠(guan)(guan)(guan)肺炎(yan)疫(yi)(yi)(yi)情(qing)防控大(da)局(ju),超常规(gui)创新(xin)(xin)开展(zhan)应(ying)急(ji)审(shen)评(ping)审(shen)批(pi),加强审(shen)评(ping)服务保障(zhang),全力做好新(xin)(xin)冠(guan)(guan)(guan)病毒(du)(du)疫(yi)(yi)(yi)苗(miao)审(shen)评(ping)过程中的(de)(de)各(ge)项工作(zuo)。面对新(xin)(xin)冠(guan)(guan)(guan)肺炎(yan)疫(yi)(yi)(yi)情(qing)对新(xin)(xin)冠(guan)(guan)(guan)病毒(du)(du)疫(yi)(yi)(yi)苗(miao)药(yao)(yao)物的(de)(de)急(ji)迫需求(qiu),药(yao)(yao)审(shen)中心坚(jian)持尊(zun)重(zhong)科学规(gui)律,建立早期介入(ru),持续跟踪,主动(dong)(dong)服务、研审(shen)联(lian)动(dong)(dong)的(de)(de)工作(zuo)机制,始终保持24小(xiao)时(shi)与企(qi)业畅通沟通的(de)(de)状(zhuang)态,无论多晚,即使是凌(ling)晨(chen)3-4点(dian)钟,都(dou)会第一时(shi)间(jian)反馈研发(fa)企(qi)业诉求(qiu),在(zai)推(tui)动(dong)(dong)境(jing)外临(lin)床(chuang)试(shi)(shi)验上强化(hua)担当,在(zai)创新(xin)(xin)审(shen)评(ping)审(shen)批(pi)中挖潜增效(xiao),成(cheng)功(gong)高(gao)效(xiao)推(tui)动(dong)(dong)国药(yao)(yao)集团新(xin)(xin)冠(guan)(guan)(guan)病毒(du)(du)疫(yi)(yi)(yi)苗(miao)附(fu)条件批(pi)准(zhun)上市(shi)和5个疫(yi)(yi)(yi)苗(miao)品(pin)种进入(ru)Ⅲ期临(lin)床(chuang)试(shi)(shi)验,确保中国新(xin)(xin)冠(guan)(guan)(guan)病毒(du)(du)疫(yi)(yi)(yi)苗(miao)走(zou)在(zai)世(shi)界前列,及时(shi)有力支撑了疫(yi)(yi)(yi)情(qing)防控大(da)局(ju)。同时(shi)贯彻落实习近平总书记(ji)坚(jian)持中西医结(jie)合、中西药(yao)(yao)并用的(de)(de)重(zhong)要指(zhi)示精神,主动(dong)(dong)对接临(lin)床(chuang)救(jiu)治中应(ying)用的(de)(de)“三药(yao)(yao)三方”生产企(qi)业和研发(fa)单位,积极做好有效(xiao)中药(yao)(yao)方剂转化(hua)产品(pin)注册和临(lin)床(chuang)试(shi)(shi)验申请技术指(zhi)导,确保中药(yao)(yao)第一时(shi)间(jian)用于新(xin)(xin)冠(guan)(guan)(guan)肺炎(yan)患者救(jiu)治。这些成(cheng)果(guo)不(bu)(bu)仅确保了防疫(yi)(yi)(yi)的(de)(de)应(ying)急(ji)所需,还为常态化(hua)疫(yi)(yi)(yi)情(qing)防控准(zhun)备了重(zhong)要的(de)(de)战(zhan)(zhan)略资源,不(bu)(bu)仅提(ti)振了国人战(zhan)(zhan)胜疫(yi)(yi)(yi)情(qing)的(de)(de)信(xin)心,还为全球疫(yi)(yi)(yi)情(qing)防控贡(gong)献了中国力量。

二是强化(hua)(hua)(hua)服(fu)务(wu)(wu)(wu)申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)。在新冠(guan)肺炎疫(yi)情防控常态化(hua)(hua)(hua)的(de)情况下,全面落实新冠(guan)肺炎疫(yi)情联防联控措施(shi),最大限(xian)度减少人(ren)(ren)员流(liu)(liu)(liu)(liu)(liu)(liu)动聚集(ji),阻断(duan)疫(yi)情传(chuan)播扩散渠道,切(qie)实保(bao)障申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)的(de)生命(ming)安全和(he)(he)身体健(jian)康,暂停现场咨询业务(wu)(wu)(wu)的(de)同时开通(tong)(tong)(tong)(tong)(tong)了电话咨询业务(wu)(wu)(wu)。增(zeng)设立(li)了8个联系(xi)邮(you)箱,申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)可以邮(you)件咨询问题(ti)并提供(gong)在审(shen)品种受(shou)理(li)(li)号等信息(xi),项(xiang)目管(guan)(guan)理(li)(li)人(ren)(ren)员将在3个工(gong)作日(ri)内与该受(shou)理(li)(li)号相关的(de)申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)进(jin)行(xing)联系(xi)。通(tong)(tong)(tong)(tong)(tong)过不(bu)断(duan)丰富和(he)(he)拓(tuo)展沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)的(de)渠道和(he)(he)方式,服(fu)务(wu)(wu)(wu)和(he)(he)便利申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren);为鼓励创新,更好地体现沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)的(de)服(fu)务(wu)(wu)(wu)属性,结合《药(yao)(yao)(yao)品注册(ce)(ce)管(guan)(guan)理(li)(li)办法》,从(cong)药(yao)(yao)(yao)物研制规律和(he)(he)注册(ce)(ce)要求(qiu)(qiu)出发(fa),秉持(chi)(chi)为药(yao)(yao)(yao)品注册(ce)(ce)申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)服(fu)务(wu)(wu)(wu)的(de)原则(ze),修订后(hou)发(fa)布了《药(yao)(yao)(yao)物研发(fa)与技(ji)术审(shen)评(ping)沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)管(guan)(guan)理(li)(li)办法》。在保(bao)证受(shou)试者安全性的(de)基础(chu)上(shang),将Ⅱ类(lei)会议划分为依法应沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)、原则(ze)上(shang)应当沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)、可以沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)三类(lei)情形(xing),并明(ming)确和(he)(he)细(xi)化(hua)(hua)(hua)了三类(lei)沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)的(de)情形(xing)和(he)(he)要求(qiu)(qiu);为提高沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)申(shen)(shen)(shen)(shen)(shen)请办理(li)(li)的(de)可预(yu)见性和(he)(he)效率(lv),药(yao)(yao)(yao)审(shen)中心(xin)通(tong)(tong)(tong)(tong)(tong)过持(chi)(chi)续(xu)优化(hua)(hua)(hua)沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)管(guan)(guan)理(li)(li),细(xi)化(hua)(hua)(hua)环节时限(xian)控制,确保(bao)了申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)能够(gou)尽快享受(shou)到(dao)优质的(de)沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)服(fu)务(wu)(wu)(wu),努力满足申(shen)(shen)(shen)(shen)(shen)请人(ren)(ren)逐年(nian)(nian)增(zeng)加的(de)沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)需求(qiu)(qiu),将2020年(nian)(nian)沟(gou)(gou)(gou)通(tong)(tong)(tong)(tong)(tong)交(jiao)(jiao)(jiao)(jiao)流(liu)(liu)(liu)(liu)(liu)(liu)申(shen)(shen)(shen)(shen)(shen)请办理(li)(li)量(liang)提升至2019年(nian)(nian)办理(li)(li)量(liang)的(de)1.31倍,这也(ye)是2016年(nian)(nian)办理(li)(li)量(liang)的(de)11.35倍。

三是持续改(gai)善内部工作(zuo)作(zuo)风,提(ti)(ti)高工作(zuo)效率。这一年药(yao)(yao)(yao)审(shen)(shen)(shen)中心继续深化(hua)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批制(zhi)度改(gai)革,持续优化(hua)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)流(liu)程,严格时限(xian)管理,实施审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)任(ren)务分析会制(zhi)度,加强项目(mu)督(du)导,鼓励药(yao)(yao)(yao)品(pin)创(chuang)新,推动(dong)仿制(zhi)药(yao)(yao)(yao)高质量(liang)(liang)发(fa)展,审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)质量(liang)(liang)和(he)效率有了(le)极大(da)地提(ti)(ti)升(sheng),2020年全年审(shen)(shen)(shen)结任(ren)务整体按时完成(cheng)率创(chuang)历史新高。药(yao)(yao)(yao)品(pin)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批的可(ke)预期(qi)性(xing)进一步提(ti)(ti)高,顺利完成(cheng)《十(shi)三五(wu)药(yao)(yao)(yao)品(pin)安(an)全规划》涉及药(yao)(yao)(yao)品(pin)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批改(gai)革目(mu)标。通(tong)过(guo)5年来深化(hua)药(yao)(yao)(yao)品(pin)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)审(shen)(shen)(shen)批制(zhi)度改(gai)革的不懈(xie)努力,药(yao)(yao)(yao)审(shen)(shen)(shen)中心实现了(le)量(liang)(liang)变(bian)到(dao)质变(bian)的飞跃,药(yao)(yao)(yao)品(pin)平均审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)时限(xian)大(da)幅(fu)压缩,审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)能力大(da)幅(fu)提(ti)(ti)升(sheng),一大(da)批创(chuang)新药(yao)(yao)(yao)、临床急需药(yao)(yao)(yao)获批上市,累计通(tong)过(guo)和(he)视(shi)同通(tong)过(guo)一致性(xing)评(ping)(ping)(ping)(ping)价审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)的品(pin)种已达445个(ge),为十(shi)四五(wu)药(yao)(yao)(yao)品(pin)审(shen)(shen)(shen)评(ping)(ping)(ping)(ping)事业(ye)的发(fa)展奠定了(le)坚实的基础。

药审中心将(jiang)深入(ru)梳理在(zai)提(ti)高审评效(xiao)率、创新(xin)审评方(fang)式等方(fang)面的(de)经验做法,使应(ying)急状态下的(de)临时性措施,有序地上升(sheng)为常态化(hua)审评工作长效(xiao)机制(zhi),将(jiang)被动选(xuan)择但(dan)被实践证(zheng)明(ming)长期有效(xiao)的(de)方(fang)法转化(hua)为常态化(hua)条(tiao)件下提(ti)高审评能力的(de)主动选(xuan)择。

十、加大药品审评审批信息公(gong)开力度

药(yao)(yao)审(shen)(shen)(shen)中心(xin)持(chi)续推(tui)进技(ji)(ji)术审(shen)(shen)(shen)评(ping)(ping)的(de)(de)(de)信(xin)(xin)息公(gong)(gong)开(kai)(kai)工作,提(ti)高药(yao)(yao)品(pin)审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)工作透明(ming)度(du)。一是(shi)完善(shan)信(xin)(xin)息公(gong)(gong)开(kai)(kai)制度(du),发布了(le)(le)《药(yao)(yao)品(pin)审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)信(xin)(xin)息公(gong)(gong)开(kai)(kai)管(guan)理(li)(li)办法》,明(ming)确信(xin)(xin)息公(gong)(gong)开(kai)(kai)的(de)(de)(de)范围(wei)、种(zhong)类、时限等(deng)要求(qiu),为做好信(xin)(xin)息公(gong)(gong)开(kai)(kai)工作提(ti)供了(le)(le)制度(du)依(yi)据(ju)。二(er)是(shi)大力(li)推(tui)动新(xin)药(yao)(yao)技(ji)(ji)术审(shen)(shen)(shen)评(ping)(ping)报告(gao)的(de)(de)(de)公(gong)(gong)开(kai)(kai),自开(kai)(kai)展工作以(yi)来(lai)已完成公(gong)(gong)开(kai)(kai)新(xin)药(yao)(yao)技(ji)(ji)术审(shen)(shen)(shen)评(ping)(ping)报告(gao)316个,指导行业(ye)研发,更好的(de)(de)(de)服务药(yao)(yao)品(pin)注册(ce)申(shen)(shen)请人和公(gong)(gong)众。三是(shi)加大技(ji)(ji)术审(shen)(shen)(shen)评(ping)(ping)过程信(xin)(xin)息公(gong)(gong)开(kai)(kai)力(li)度(du),通(tong)过药(yao)(yao)审(shen)(shen)(shen)中心(xin)网站向(xiang)申(shen)(shen)请人进一步公(gong)(gong)开(kai)(kai)了(le)(le)审(shen)(shen)(shen)评(ping)(ping)排队信(xin)(xin)息、优先(xian)审(shen)(shen)(shen)评(ping)(ping)的(de)(de)(de)状态(tai)信(xin)(xin)息、沟通(tong)交(jiao)流申(shen)(shen)请及办理(li)(li)信(xin)(xin)息等(deng)信(xin)(xin)息,新(xin)增了(le)(le)“突破性(xing)(xing)治疗(liao)公(gong)(gong)示”的(de)(de)(de)栏目,公(gong)(gong)开(kai)(kai)了(le)(le)“拟(ni)突破性(xing)(xing)治疗(liao)品(pin)种(zhong)、异(yi)议论证(zheng)结(jie)果(guo)”等(deng)信(xin)(xin)息。方便申(shen)(shen)请人查询信(xin)(xin)息,进一步拓(tuo)宽了(le)(le)申(shen)(shen)请人的(de)(de)(de)沟通(tong)渠(qu)道,及时回应社(she)会关切,提(ti)高了(le)(le)审(shen)(shen)(shen)评(ping)(ping)审(shen)(shen)(shen)批(pi)工作的(de)(de)(de)透明(ming)度(du)。

 十一、2021年(nian)重点工作安排

2020年,药(yao)(yao)品审(shen)评(ping)(ping)工作(zuo)取得了一定(ding)(ding)进展(zhan),但仍存在(zai)着一些问题(ti):一是注册申请申报(bao)量(liang)(liang),特别是创(chuang)新(xin)药(yao)(yao)申报(bao)量(liang)(liang)连年递增,药(yao)(yao)审(shen)中心审(shen)评(ping)(ping)队伍规(gui)模结构(gou)与审(shen)评(ping)(ping)任务量(liang)(liang)配比失衡;二是高层次及(ji)紧(jin)缺专(zhuan)业(ye)(ye)人才引进难、新(xin)进审(shen)评(ping)(ping)员急需长期(qi)专(zhuan)业(ye)(ye)培训等审(shen)评(ping)(ping)能力现代化短板问题(ti)突出;三是新(xin)旧注册相关规(gui)定(ding)(ding)过渡(du)期(qi)间,应(ying)及(ji)时研究问题(ti),给予相应(ying)的解决措施。2021年药(yao)(yao)审(shen)中心将紧(jin)密围绕(rao)国家药(yao)(yao)监局工作(zuo)部署,重点开展(zhan)以下工作(zuo):

(一)积(ji)极推(tui)动制度体系建设(she)

完善(shan)新《药(yao)品注(zhu)册(ce)管理(li)(li)办法(fa)》配套文件,做好新旧注(zhu)册(ce)相关规定过(guo)渡(du)期相关工作,稳妥处理(li)(li)历史问题;继续开展药(yao)品审评(ping)流程导向(xiang)科学管理(li)(li)体系(xi)建设工作,构建长效运行机制,完善(shan)药(yao)品技术指(zhi)导原则(ze)体系(xi),规范中(zhong)心制度体系(xi)建设,推动审评(ping)体系(xi)和审评(ping)能力现代(dai)化(hua);深(shen)入推进(jin)监(jian)管科学研究(jiu),深(shen)化(hua)与高校、科研院所合作,加(jia)快首(shou)批(pi)重点(dian)项目研究(jiu)成果(guo)转化(hua)。

(二)毫不放(fang)松做好应急(ji)审评(ping)审批工(gong)作

始终(zhong)保持(chi)应急工(gong)作状(zhuang)态,完善(shan)研审(shen)(shen)联动(dong)机制,坚(jian)持(chi)特事特办(ban),促进包(bao)括中医(yi)药(yao)、抗(kang)体药(yao)物等(deng)新(xin)冠肺炎治(zhi)疗(liao)药(yao)物的研发(fa);持(chi)续做好(hao)应急审(shen)(shen)评审(shen)(shen)批核(he)查检验协(xie)调(diao)工(gong)作;继续强化服务指(zhi)导(dao),持(chi)续跟进各条技术路线(xian)新(xin)冠病(bing)毒(du)疫苗(miao)研发(fa)进展(zhan),依法(fa)依规严格审(shen)(shen)评,继续做好(hao)新(xin)冠肺炎治(zhi)疗(liao)药(yao)物和新(xin)冠病(bing)毒(du)疫苗(miao)审(shen)(shen)评工(gong)作;全面总结应急审(shen)(shen)评审(shen)(shen)批工(gong)作经验,完善(shan)审(shen)(shen)评审(shen)(shen)批制度体系,进一(yi)步激发(fa)药(yao)品创新(xin)发(fa)展(zhan)活(huo)力(li)。

(三)加快(kuai)建立符合中(zhong)医药特点(dian)的中(zhong)药审评机制(zhi)体系(xi)

构建中(zhong)医药(yao)(yao)理论、中(zhong)药(yao)(yao)人用经验和(he)临床(chuang)试(shi)验“三结(jie)合(he)”的(de)审评(ping)(ping)(ping)证据体系,组建古代(dai)经典(dian)名(ming)方(fang)中(zhong)药(yao)(yao)复方(fang)制(zhi)剂专家(jia)审评(ping)(ping)(ping)委员会,扎实推进中(zhong)药(yao)(yao)审评(ping)(ping)(ping)审批(pi)(pi)改革;参考“三方(fang)”审评(ping)(ping)(ping)审批(pi)(pi)经验,逐步探索(suo)适合(he)古代(dai)经典(dian)名(ming)方(fang)的(de)中(zhong)药(yao)(yao)复方(fang)制(zhi)剂的(de)审评(ping)(ping)(ping)指导(dao)原则和(he)标准,完善符合(he)中(zhong)医药(yao)(yao)特点(dian)的(de)技术指导(dao)原则;加快确(que)有临床(chuang)价值的(de)中(zhong)药(yao)(yao)新药(yao)(yao)审批(pi)(pi),发挥中(zhong)医药(yao)(yao)在疾病防治(zhi)中(zhong)的(de)独特优(you)势(shi)。

(四(si))持续深(shen)化审评审批制(zhi)度改革

巩固按(an)时限审(shen)评改革(ge)成(cheng)果,完善(shan)项(xiang)目管理工(gong)作机(ji)制;完善(shan)专家咨询委员会制度,解决争议重(zhong)大(da)疑难问题,利用(yong)巡视整改要求(qiu)推(tui)动制度改革(ge),加大(da)审(shen)评审(shen)批信(xin)息公开(kai)力度,优化沟通(tong)交流制度,提高(gao)审(shen)评服务(wu)水平;细化上市(shi)(shi)药(yao)品变更管理技术要求(qiu),指导(dao)药(yao)品上市(shi)(shi)许可(ke)持有人开(kai)展上市(shi)(shi)后持续(xu)(xu)研(yan)究;进一步加强临床试验期间安全性评价及药(yao)物警戒(jie)体系(xi)建(jian)(jian)设;持续(xu)(xu)推(tui)进ICH指导(dao)原则在国内(nei)转化实施;加快(kuai)(kuai)审(shen)评数字化建(jian)(jian)设,推(tui)进eCTD系(xi)统使用(yong)。加快(kuai)(kuai)推(tui)进研(yan)发生产主体信(xin)息库建(jian)(jian)设。

(五)坚(jian)持鼓励药(yao)品研发创新

持(chi)续完善药(yao)品审(shen)(shen)评(ping)审(shen)(shen)批(pi)制度体系,坚持(chi)以(yi)安全(quan)有效为(wei)根(gen)本标准(zhun),优(you)(you)化(hua)审(shen)(shen)评(ping)资源(yuan)配置,在创(chuang)新药(yao)审(shen)(shen)评(ping)中探索实施(shi)“提前介入”“研审(shen)(shen)联动(dong)”“平行检(jian)验”“前置检(jian)验”等方式;继(ji)续鼓(gu)励新药(yao)好药(yao)研发(fa)创(chuang)新,强化(hua)沟(gou)通交流,优(you)(you)先配置资源(yuan),进一步细化(hua)和实施(shi)突破性治疗药(yao)物、附(fu)条件(jian)批(pi)准(zhun)、优(you)(you)先审(shen)(shen)评(ping)、特别(bie)审(shen)(shen)批(pi)等加快审(shen)(shen)评(ping)程序(xu),加快临床急需境(jing)外新药(yao)、罕见(jian)病(bing)用药(yao)、儿童用药(yao)、重(zhong)大传染(ran)病(bing)用药(yao)等上市(shi)速度。

(六)推动仿制药(yao)高质量发展

持(chi)续完善(shan)仿(fang)(fang)制药参比制剂遴选,坚持(chi)标(biao)准(zhun)不降低的原(yuan)则,稳妥有序推进(jin)仿(fang)(fang)制药质量(liang)和(he)疗效(xiao)一致性评(ping)价;进(jin)一步(bu)完善(shan)仿(fang)(fang)制药相关技术指(zhi)导原(yuan)则和(he)标(biao)准(zhun)体系建设;以(yi)建立审(shen)评(ping)要(yao)点(dian)体系为基(ji)础,推动仿(fang)(fang)制药审(shen)评(ping)科学规范、标(biao)准(zhun),提高仿(fang)(fang)制药审(shen)评(ping)质量(liang)和(he)效(xiao)率。

(七)优(you)化人才队伍建设

按照国家药(yao)监局(ju)统(tong)一(yi)(yi)部(bu)署(shu),全力(li)指导和(he)推进长(zhang)三(san)角、大(da)湾区(qu)两个分(fen)中心建设;以专业(ye)培训为抓手,进一(yi)(yi)步加(jia)强(qiang)药(yao)品审评(ping)队伍能力(li)建设;配合药(yao)品审评(ping)业(ye)务,积极开(kai)展人(ren)员(yuan)招(zhao)(zhao)聘工作,加(jia)强(qiang)队伍建设;进一(yi)(yi)步加(jia)强(qiang)专业(ye)技术(shu)队伍建设,完善(shan)专业(ye)技术(shu)队伍晋升等(deng)制(zhi)度;进一(yi)(yi)步严格人(ren)员(yuan)招(zhao)(zhao)聘条件(jian),规范人(ren)员(yuan)离职,严格队伍管理。

 十二、结语(yu)

大(da)鹏一日(ri)同风起,扶摇直上(shang)九万里。2021年(nian)是实(shi)施“十四五(wu)”规划的开局之年(nian),药审中心将在国家药监局的坚(jian)强(qiang)领导下,坚(jian)持(chi)以(yi)习近平(ping)新(xin)时代(dai)中国特色社会主义思想(xiang)为(wei)指导,全面贯(guan)彻党的十九大(da)和(he)十九届二(er)中、三中、四中、五(wu)中全会精(jing)神,坚(jian)持(chi)以(yi)人民为(wei)中心的发(fa)(fa)展(zhan)思想(xiang),按照立足(zu)新(xin)发(fa)(fa)展(zhan)阶(jie)段,贯(guan)彻新(xin)发(fa)(fa)展(zhan)理念(nian),构(gou)建新(xin)发(fa)(fa)展(zhan)格局的要(yao)求,以(yi)习近平(ping)总书记(ji)“四个最严”要(yao)求为(wei)根(gen)本(ben)遵循(xun),以(yi)鼓励(li)创新(xin)推(tui)动药品(pin)(pin)高质量发(fa)(fa)展(zhan)为(wei)主题,以(yi)深(shen)化药品(pin)(pin)审评(ping)审批(pi)制度改革为(wei)主线,以(yi)满足(zu)人民日(ri)益增长的美好生活需要(yao)为(wei)根(gen)本(ben)目的,以(yi)建设国际化现代(dai)化科(ke)学化药品(pin)(pin)审评(ping)机构(gou)为(wei)根(gen)本(ben)动力(li),坚(jian)持(chi)为(wei)国为(wei)民履职尽责,切(qie)实(shi)保(bao)(bao)障药品(pin)(pin)安全有(you)效(xiao)可及,保(bao)(bao)护和(he)促(cu)进公众健康,努(nu)力(li)实(shi)现“十四五(wu)”时期发(fa)(fa)展(zhan)开好局、起好步(bu),以(yi)优异成绩迎接(jie)中国共产党成立100周(zhou)年(nian)。

 

 

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来源:国家药(yao)品(pin)监督管(guan)理局(ju)网站,具体详见:http://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20210621142436183.html