浙江省医疗机构制剂申报及审批程序

1、spring a nda utumn ofsecurity inspecti ons,floodcontrol a nd i nspecti on,safetypr oduction mont h, daysupervision of productionsafetyand theOlympic Games andotherDelegates,staff: Hell o! inthe r un-uptot he Spri ng Festival,we held one sess ion offourstaffrepresentativesConference2013 -workshop,ful

2、l back i n2012,careful analy sis ofthecurr ent sit uation,discuss2013 development plans.Here,onbehalf of my company2013w ork reports tothe Ge neralAssembly,for consi deration.PillarI, 2012ba ckin 2012, XX pow er companie sadheretothe party's 17great spiritfor guidance, comprehe nsivelyimpleme nt

3、the scie ntificconcept ofdevel opment, prom oting cost-lea dership strategy, standards,focuson impl ementation, lea nmanagem ent, contin uouslyimpr ove,sm ooth present safety situati on ofenterpri se manageme nt, busi ness ma nagementa nd contr olscientific a nd stan dardize d,and thede dicati on of

4、staff,managea harmoni ousand dem ocraticatmosphereofthe good situation.Mai nindicat ors areasfoll ows:-t he battery i ndicat or: powerge nerationtotaled7.815billionk Wh,bey ondthe a nnualbudget impl ementation ca pacity of315million k Wh, an increase of757mil lion kWh.Salestotaled 7.425 billion k Wh

5、,exceedi ng sale s of330 million kWhtheannual Exe cutive budget,ani ncrea se of729 million k Wh. -S ecurity measures: unplanned outages2.5times.No personali njury a cci dent occurre d, no majoraccide ntand above,nomajor fireacci dent swithoute nvironmental polluti on ac cidents,safetyforthre econsec

6、utiveyearsto mai ntain sta bilityto g ood posture.Busi nessfi nancialindicat ors:total profits of255milli onYuan, beyond t hea nnualbudget of207million Yuan,beyondt heData ng companyindex41.89 millionYuan,a n increase of1.76mil lionYua n,FCM a ssessment atgrade four.-Energy: power supply standard co

7、al compl eting312.25 g/k Wh, down 0.1 g /kWh;integrate dauxiliary powerconsumpti on ratio in 5.12%, dow n 0.26%; pollutantemissions performancegrea tly reduce d compare dto lastyea r, carbon 0.09 g /kWh,sulfur dioxide 0.104 g /kWhNOx0.512 g/kWh; dust removaefficiency of more t han 99.8%.-Relia bilit

8、yindex: equivale nt availabilityfact orin 93.47%,increase d 7.95% from ayearearlier.Equivalentforced outage rate 0.08%,0.16%re ductionoverthe same peri oda yearearli er.Majorachievement s: first,we shoul da dheretot hetwo "manage mentsystem" basis, stre ngthe ningtechnologi calresear ch, s

9、trengthe nhi dden ha zards controlandintrinsic safety Enterprise construction took newste ps. -The tw o "managementsystem" for improvement. Focus onpr omotingthe powerofthecompa ny managementsystem a ndtheapplicati ona nd implementati on ofthe safety loop five-starmanagementsystem,improvet

10、hesafety management system,realize thesystem ofsafetycontrol.Further regulatesecurityroutine s,safetysupervisi on a ndmanag ement netw orkrole to playtoachieve closed-loop.Stre ngtheningthe supervisi on a nd management of ha bitualvi olationof, strengthening thesafety supervisi on ofoutsourci ngcont

11、ract ors.Carried out in浙江省医疗机构制剂申报及审批程序（征求意见稿）为加强医院医疗机构制剂的管理, 规范医疗机构制剂的审批 ,根据 医疗机构制剂注册管理办法（ 以下简称 办法 ） ,制订本程序。一、新制剂申报临床研究的新制剂由省局的市局受理点受理，市局对申报资料初步审查，省局审批。（一）新制剂初审市局初审程序：1 、市局受理点受理（5 日）（ 1 ）申报资料包括：医疗机构制剂注册申请表；申报资料（见办法附件一）；电子文档（申请表、质量标准、说明书、综述资料）。（ 2）对申报资料进行形式审查，符合要求的，导入电子系统，予以受理。2、市局初审查（30 日）（ 1 ）对资料的

12、真实性、规范性和完整性进行审核；（ 2） 10 日内组织对现场核查：核查与申报资料相关的实验原始记录真实性及与申报资料是否一致；核查试制样品的研究条件和检验条件，三批ctivities,compre hensive andtamping SafetyFoundation .Troubleshooti ng,manageme ntmechanism,give full playtorole oftechnical supervisi on a nd realizati on oftrouble shooti ng, manageme nt,improve d process management

13、.Thisyear compl etedthe boil erlower header leakage,boilerpressure, amajor ri sk management, com pleted29 ofgreat risksand 3 Ge neralproblems of governa nce. Com pletechemistrylab constructi on,thermalcontrol,and com pletethe boiler scalei ntegrated management,hostshaftingvibrationof 10scientific an

14、dte chnol ogical proje cts,suchas.Completesupercriti cal630MW on-line simulation systemdev elopment andapplication ofcirculati ngwater MCCstandby pow ertransformation,thetransformationof desulfurizationwastewater,the unitwatersupplysystem ofcomprehe nsive treatment a nd di schargevalvemodifi cation

15、ofcoalmill 5keytechnologi caltransformation pr ojects,grouphealt h isimpr oved. -S cience a nd technologyi nnovation i s furtherspring a nda utumn ofsecurity inspecti ons,floodcontrol a nd i nspecti on,safetypr oduction mont h, daysupervision of pr oductionsafetyand the Olympic Games andotherDelegat

16、es,staff: Hell o! inthe r un-uptot he Spri ng Festival,we held one session offourstaffrepresentativesConference2013 -workshop,full back i n2012,careful analy sis ofthecurr ent sit uation,discuss2013 development plans.Here,onbehalf of my company2013w ork reports tothe Ge neralAssembly,for consi derat

17、ion.PillarI, 2012ba ckin 2012, XX pow er companie sadheretothe party's 17great spiritfor guidance, comprehe nsivelyimpleme ntthe scie ntificconcept ofdevel opment, prom oting cost-lea dership strategy, standards,focuson impl ementation, lea nmanagem ent, continuously impr ove,sm ooth present saf

18、ety situati on ofenterpri se manageme nt, busi ness ma nagementa nd contr olscientific a nd standardize d,and thede dicati on ofstaff,managea harmoni ousand dem ocraticatmo sphereofthe goodsituation.Mai nindicat orsare asfoll ows:-t he battery i ndicat or: powerge nerationtotaled7.815billionk Wh,bey

19、 ondthe a nnualbudget impl ementation ca pacity of315million k Wh, an increase of757mil lion kWh.Salestotaled 7.425 billion k Wh,exceedi ng sale s of330 million kWhtheannual Exe cutive budget,ani ncrea se of729 million k Wh.-S ecurity measures: unplanned outages2.5times.No personali njury a cci dent

20、 occurre d, no majoraccide ntand above,nomajor fireacci dent swithoute nvironmental polluti on accide nts,safetyforthre econsecutiveyearsto mai ntain sta bilityto g ood posture.Busi nessfi nancialindicat ors:total profits of255milli onYuan, beyond t hea nnualbudget of207million Yuan,beyondt heData n

21、g companyindex41.89 millionYuan,a n increase of1.76mil lion Yua n,FCM a ssessment atgrade four.-Energy: power supply standard coal compl eting312.25 g/k Wh, down 0.1 g /kWh;integrate dauxiliary powerconsumpti on ratio in 5.12%, dow n 0.26%; pollutantemissions performancegrea tly reduce d compare dto

22、 lastyea r, carbon 0.09 g /kWh,sulfur dioxide 0.104 g /kWhNOx0.512 g/kWh; dust removaefficiency of more t han 99.8%.-Relia bilityindex: equivale nt availabilityfact orin 93.47%,increase d 7.95% from ayearearlier.Equivalentforced outage rate 0.08%,0.16%re ductionoverthe same peri oda yearearli er.Maj

23、orachievement s: first,we shoul da dheretot hetwo "manage mentsystem" basis, stre ngthe ningtechnologi calresear ch, strengthe nhi dden ha zards controlandintrinsic safety Enterprise construction took newste ps. -The tw o "managementsystem" for improvement. Focus onpr omotingthe

24、powerofthecompa ny managementsystem a ndtheapplicati ona nd implementati on ofthe safety loop five-starmanagementsystem,improvethesafety management system,realize thesystem ofsafetycontrol.Further regulatesecurityroutine s,safetysupervisi on a ndmanag ement netw orkrole to playtoachieve closed-loop.

25、Stre ngtheningthe supervisi on a nd management of ha bitualvi olationof, strengthening t he safety supervisi on ofoutsourci ngcontract ors.Carried out in试制样品的批生产记录和检验原始记录，并出具现场核查报告。（ 3 ）抽取三批试制样品并通知省药检所检验。抽取样品的数量为检验的3 倍量，填写抽样记录单和送检通知单，贴封后送省药品检验所进行制剂标准复核和检验。（ 4）市局完成资料审核、现场核查和样品抽样后，出具审核意见，将两套完整的资料上报省局受

26、理大厅。上报资料包括：（ 1 ） 医疗机构制剂注册申请表；（2）申报资料；（3）现场核查报告表；（4）市局综合审查意见；（ 5）抽样记录单和送检验通知单各1 份；（6）市局行政许可内部流转单。（二）新制剂的审批省局审批程序：1 、省局受理大厅。（ 1 ）对市局上报的资料（包括纸质和电子）进行核对并签收登记。（ 2 ）对药品检验所报送的检验报告书和标准复核意见进行查收并登记。（ 3）将受理申报资料一套送交药品注册处，一套送交省ctivities,compre hensive andtamping SafetyFoundation .Troubl eshooti ng,manageme ntmec

27、hanism,give full playtorole oftechnicalsupe rvision andrealizationoftroubleshooting, management,impr oved process management.Thisyearcompleted t heboiler l owerhea derleakage, boil er pressure,a majorrisk management, completed29 ofgreat risksand 3 Generalproblemsofgovernance. Complete chemi stry lab

28、 c onstr uction,thermalcontrol,and completet he boilerscale integrated management, hostshaftingvi bration of10 scie ntificand technologi calpr ojects,such a s.Completesupercriti cal630MW on-line simulation systemdevel opme ntand applicati on ofcir culati ngwater MCCstandbypower transformation,thetra

29、nsformation ofdesulfuri zation w astewater,the unitwater supplysystem ofcomprehensivetreatmentand dischargevalvemodification ofcoal mill5key technologi caltransformation projects,grouphealth is improve d.-Science andtechnology innovati on isfurt herincrease d.Strengt hen t he characteristi csofsuper

30、 critical unitmajori ssues,graduallycleari ngthe particularityofsupercriti cal unitand reg ularity. Developedmot oroiltimemanagement,switcha ction times,statistics,coal-aidedmea sureme nt software,impr ovesthe producti on level of lean manag ement. Increase d investment i n sci enceand technology, r

31、eporting scienceand technology proje cts and 14techni cal pr ojecttotal cost percentage of thetotala nnualpr oduction outputof0.25%."Large-scalecoal-fired powerpla ntflue gas de sulfuri zation, de nitrificationcomplete development and appli cation ofkeytechnologies" project ,w on thenation

32、alscience andtechnology progress second prize.630MWsupercritical units optimize d controlstrategiesa nd the630M Wdevelopmentand application ofon -line simulation systemforsupercriticalunits,super critical600M W unit s ofturbi ne drivenboilerfeed pump set ofcom prehe nsive treatment ofdefects Data ng

33、 technol ogy respectively oneortwo andthird.Meanwhile,informationtechnologyachieveme nts,the companywas named "Chi na powerinformati on te chnology benchmarki ng enter prises."-Repairand mai ntena nce has impr ovedfurther.M odifythe i nspecti onsta ndards andstandardson areg ularba sis,sta

34、 ndardizing w ork procedures, checki ng andi nspecti on proje ct.Dee pe ningthe BFS+system,a ndimpl ements mainte nance informati on shared. Re organizi ng RBlogi cagain,a nd e nsure thesuccess oftheRB. Innovatingthe mechanism ofmainte nance manageme nt, impleme nted apr oje ctmanagersystem.Successf

35、ulcompletion oftwoautonom ousmai ntenance,reliabilityimprovedsteadily.Impleme ntingtwo c-l evel maintena nce,projectthemselves48.7%and42.3%, respectively.Accom plish tw ocir culati ng pum ps repaira nd overha uloffourMill s,mainte nance teams togetexercise.Promotethe workof energysaving a nd consump

36、ti onre ducing, compl etethe unit energy consum ption diagnosi s, pla ntwater bala ncetest,10 energy-saving pr oje cts.Second,we shoulda dher e to "three" ont heeconomic benefits ofimproving, outreach44Delegates,staff: Hell o! inthe r un-uptot he Spri ng Festival,we held one session offour

37、staffrepresentativesConference2013 -workshop,full back i n2012,careful analysis ofthecurr ent sit uation,discuss2013 development plans.Here,onbehalf of my company20 13w ork reports tothe Ge neralAssembly,for consi deration.PillarI, 2012ba ckin 2012, XX pow er companie sadheretothe party's 17grea

38、t spiritfor guidance, comprehe nsivelyimpleme ntthe scie ntificconcept ofdevel opment, prom oting cost-lea dership strategy, standards,focuson impl ementation, lea nmanagem ent, continuously impr ove,sm ooth present safety situati on ofenterpri se manageme nt, busi ness ma nagementa ndcontr olscient

39、ific a nd standardize d,and thede dicati on ofstaff,managea harmoni ous and dem ocraticatmosphereofthe good situation.Mai nindicat orsare asfoll ows:-t he battery i ndicat or: powerge nerationtotaled7.815billionk Wh,bey ondthe a nnualbudget impl ementation ca pacity of315million k Wh, an increase of

40、757mil lion kWh.Salestotaled 7.425 billion k Wh,exceedi ng sale s of330 million kWhtheannual Exe cutive budget,ani ncrea se of729 million k Wh.-S ecurity measures: unplanned outages2.5times.No personali njury a cci dent occurred, no majoraccidentand above,nomajor fireacci dent swithoute nvironmental

41、 polluti on accide nts,safetyforthre econsecutiveyearsto maintain stabilityto g ood posture.Busi nessfi nancialindicat ors:total profits of255milli onYuan, beyond t hea nnualbudget of207million Yuan,beyondt heData ng companyindex41.89 millionYuan,a n increase of1.76mil lionYuan,FCM assessment atgrad

42、e four.-Energy: power supply standard coal compl eting312.25 g/k Wh, down 0.1 g /kWh;integrate dauxiliary powerconsumpti on ratio in 5.12%, dow n 0.26%; pollutantemissions performancegrea tly reduce d compare dto lastyear, carbon 0.09 g/kWh,sulfur dioxide 0.104 g /kWhNOx0.512 g/kW h;dustremovaeffici

43、ency of more t han 99.8%. -Relia bilityindex: equivale nt availabilityfact orin 93.47%,increase d 7.95% from ayearearlier.Equivalentforced outage rate 0.08%,0.16%re ductionoverthe same peri oda yearearli er.Majorachievement s: first,we shoul da dheretot hetwo "manage mentsystem" basis, str

44、e ngthe ningtechnologi calresear ch, strengthe nhi dden ha zards controlandintrinsic safety Enterpriseconstruction took newste ps. -The tw o "managementsystem" for improvement. Focus onpr omotingthe powerofthecompa ny managementsystem a ndtheapplicati ona nd implementati on ofthe safety lo

45、op five-starmanagementsystem,improvethesafety management system,realize thesystem ofsafetycontrol.Further regulatesecurityroutine s,saf etysupervisi on a ndmanag ement netw orkrole to playtoachieve closed -loop. Stre ngtheningthe supervisi on a nd management of ha bitualvi olationof, strengthening t

46、 he safety supervisi on ofoutsourci ngcontract ors.Carried out in局药品审评中心。2、省局药审中心在40 日内组织完成技术审评，并将审评意见报药品注册处。技术审评需要补充资料的，发补充资料通知函。申请人应在3 个月内将补充资料报药审中心（由于实验周期原因导致延期除外）。逾期未补的，药审中心将退审意见报省局注册处。3、药品注册处审核后符合规定的，10 日内发给医疗机构制剂临床研究批件；不符合规定的，10 日内发给审批意见通知件；逾期未补资料的，发给退审通知件予以退审。4、临床研究必须在1 年内实施。5、完成临床研究后，申请人向市局报

47、送临床研究总结资料， 市局 10 日内对临床研究情况进行现场考核，填写 医疗机构制剂临床研究现场核查表，与临床总结资料一起一式二份报省局受理大厅。5、省局受理大厅对两套临床研究总结资料和现场考核表签收并登记。2 日内将接收的资料1 套交省局注册处，1套交省药品审评中心。6、药审中心在收到资料后40 日内组织完成技术审评，将审评结论报省局。7、 省局审核符合规定的，10 日内向申请人核发医疗机构制剂注册批件及制剂批准文号，并报国家食品药品监ctivities,compre hensive andtamping SafetyFoundation .Troubl eshooti ng,managem

48、e ntmechanism,give fullplaytorole oftechnicalsupe rvision andrealizationoftroubleshooting, management,impr oved process management.Thisyearcompleted t heboiler l owerhea derleakage, boil erpressure,a majorri skmanagement, completed29ofgreat risksand3 Generalproblemsofgovernance. Complete chemi stry

49、lab constr uction,thermalcontrol,and completet he boilerscale integrated management, hostshaftingvi bration of10 scie ntificand technologi calpr ojects,such a s.Completesupercriti cal630MW on-linesimulation systemdevelopme ntand applicati on ofcir culati ngwater MCCstandbypower transformation,thetra

50、nsformation ofdesulfuri zation w astewater,the unitwater supplysystem ofcomprehensivetreatmentand dischargevalvemodification ofcoal mill5key technologi caltransformation projects,grouphealth is improve d.-Science andtechnology innovati on isfurt herincrease d.Strengt hen t he characteristi csofsuper

51、 critical unitmajori ssues,graduallycleari ngthe particularityofsupercriti cal unitand reg ularity. Developedmot oroiltimemanagement,switcha ction times,statistics,coal-aidedmea sureme nt software,impr ovesthe producti on levelof lean management. Increase d investment i n sci enceand technology, rep

52、orting scienceand technology proje cts and 14technical pr ojecttotalcost percentage of thetotala nnualpr oduction outputof0.25%."Large-scalecoal-fired powerplantflue gas de sulfuri zation, de nitrificationcomplete development andappli cation ofkeytechnologies" project,w on thenationalscien

53、ce andtechnology progress second prize.630MWsupercritical units optimize d controlstrategiesa nd the630M Wdevelopmentand application ofon-line simulation systemforsupercriticalunits,super critical600M W unit s ofturbi ne drivenboilerfeed pump set ofcom prehe nsive treatment ofdefects Datang technol

54、ogy respectively one ortwo andthird.Meanwhile,informationtechnologyachieveme nts,the companywas named "Chi na powerinformati on te chnology benchmarki ng enter prises."-Repa irand mai ntena nce has impr ovedfurther.M odifythe i nspecti onsta ndards andstandardson areg ularba sis,sta ndardi

55、zing work procedures, checki ng andi nspecti onproje ct.Dee pe ningthe BFS+system,a ndimpl ements mainte nance informati on shared. Re organizi ng RBlogi cagain,a nd e nsure thesuccess oftheRB.Innovatingthe mechanism ofmaintenance manageme nt, impleme nted a proje ctmanagersystem.Successfulcompletio

56、n oftwoautonom ousmai ntenance ,reliability impr ovedstea dily.Impleme ntingtwo c-l evel maintena nce,projectthemselves48.7%and42.3%, respectively.Accom plish tw ocir culati ng pum ps repaira nd overha uloffourMill s,mainte nance teams togetexercise.Promotethe workof energysaving a nd consumpti onre

57、 ducing, compl etethe unit energy consum ption diagnosi s, pla ntwater bala nceDelegates,staff: Hell o! inthe r un-uptot he Spri ng Festival,we held one session offourstaffrepresentativesConference2013 -workshop,full back i n2012,careful analy sis ofthecurr ent sit uation,discuss2013 development pla

58、ns.Here,onbehalf of my company2013w ork reports tothe Ge neralAssembly,for consi deration.PillarI, 2012ba ckin 2012, XX pow er companie sadheretothe party's 17great spiritfor guidance, comprehe nsivelyimpleme ntthe scie ntificconcept ofdevel opment, prom oting cost-lea dership strategy, standards,focuson impl ementation, lea nmanagem ent, continuously impr ove,sm ooth present safety situati on ofenterpri se manageme nt, busi ness ma nagementa nd contr olscientific a nd standardize d,and thede dicati on ofstaff,managea harmoni ousand dem ocraticatmo sphereofthe goodsituation.Mai