保健食品注册与备案管理办法

1、the problem.The pur poseofsupervi sion,toresolve theproblem. To a dher e toand furtherimpr ovetheout city created,a ndcaremasses life,focuswork,i n-dept hinvestigation,moreout bouti quemaster pie ce, makesweofrese arch re sultsmor etointole d of decisi onvi sion,more to i n nati onalsome ha s effect

2、ofnewspaperShangpublished,fora dvance work, and publicity changde play dueofrole.Third,information submitted tobe pragmati c. Quicka ndtimel y.The ancients said:forthe timesystem;statement backfort he time bei ng, nothi ng.Therefore,the submi ssion ofinformation to do "four",that is,findth

3、e problemfaster,editorialwriting,se nd and rea dfast erappr ovaland feedba ck toimplementquickl y.Tobetr ue and accurate.True mainlyreflect thefull picture ofevents,oneis one ,two,thi s isthe life oftheinformation.Accuracy isprimarily qualitativea nd qua ntitativeque stions,quantitativeobje ctiveofp

4、ubli cQualitative logi c.To be reliablea nd useful.Wesubmit inform ation to haveaccesst o de cisi on -making, to g uide and promote t he work a nd solve practica lproblems. Mixedcum.Onthe negative informationa nd emerge ncyi nformation,ra pide scalati on instrict a ccorda nce withthe procedures,firm

5、,newspaper, ne wspa pers, neverlate,failto re port,false claim a nd skimmi ng.Investe e2.supervision andinsiston, around a nd pr otecting theiri nterests to touchthe tr uth, see k practicalre sults.Adhere t o people -orie nted,themostimportant thing is to re alize, safeguard a nd developthef undamen

6、talintere sts ofthe overwhelming majorityofthe people.Wecarry out inspe ction,so must go dee pamongt he masses,go dee p intot he realitie s,always payattention to thepeople'slivel ihood,tograsp t he publ ic sentiment,a nd e arnestly safeguardt he be nefit,addressi ng themasses arem ostconcerne d

7、 about a nd refle ctingthe stronge st issues,effortsto solve t hepr oblem ofdeci sionsimpl emented a nd not implemented. One istostick to principl es. Rightof i nspecti on is oneofthemost importantpowersofthe Office,should not only dare touse, but alsowith cauti on. So-calle ddared to use, i stohold

8、a numberofimportant issue s, bold supervisi on ov ersupervisi on,tra ckinspe ction, problemsare notsolved do not pass,the blame does not hold did notmiss, dissatisfaction ofthemasses did notmiss,the realrightofsupervision authority, with the benefits. Callwit h ca uti on, is supervisi ng de partment

9、s shouldstre ng the n the consci ousne ssofaut horizedstrictlya ccordi ng toproce dure, preventi ng thesupervi sion andexcessiveto preventadding burde n to grass-roots.Tothi s end, the supervisi on De partmentofthe Party Committeeofsupervision mustbeunder cityandCountypartyCommitteeSecretary-General

10、(Office).Second,weshould focuson.Isthe Governor, those relate dtothe gl obalEve nt,Gover northe protra cted difficult,strongGover nor duri ngemergency urgent. Not havi ng special departments in charge ofthe Ge ner alGover nor,undert he normalproce dure can do g ood thing s not Governor, not a uthori

11、zed by Countylea ders, notthe Gover nor. Third i s tosolve保健食品注册与备案管理办法（征求意见稿）第一章总则第一条目的依据为规范保健食品的注册与备案工作，根据 中华人民共和国食品安全法、中华人民共和国行政许可法，制定本办法。第二条适用范围在中华人民共和国境内生产、经营的保健食品注册与备案，适用本办法。保健食品注册，是指食品药品监督管理部门根据申请人申请，依照法定程序、条件和要求， 对申请注册的保健食品的安全、功能声称等相关申请材料进行系统评价和审评，并决定是否准予其注册的审批过程。保健食品备案，是指保健食品生产企业依照法定程序、条件和要

12、求，将与保健食品生产销售有关的材料提交食品药品监督管理部门进行登记、存档、公开、备查的过程。第三条 总局职责国家食品药品监督管理总局负责全国保健食品注册与备案管理工作。主要职责：（一）制定保健食品注册和备案相关工作管理办法；（二）制定保健食品注册技术审评工作细则；（三）保健食品技术审评机构、注册检验机构管理；（四）负责保健食品注册；（五）负责首次进口补充维生素、矿物质等营养物质保健食品备案；（六）组织对注册和备案保健食品的监督管理。第四条省局职责省、自治区、直辖市食品药品监督管理部门负责本行政区域内的保健食品备案及注册相关管理工作。主要职责：（一）承担本行政区域内保健食品备案工作；（二）履行本

13、行政区域内国内生产的保健食品试制现场核查和抽样的相关职责；（三）负责本行政区域内注册与备案的保健食品的监督管理；（四）承担国家食品药品监督管理总局委托的注册变更与延续的受理等其他工作。第五条基层局职责县、 市食品药品监督管理部门负责本行政区域内的注册和备案的保健食品监督管理工作。主要职责：（一）履行本行政区域内注册和备案保健食品的监督检查职责；（二）承担上级食品药品监督管理部门委托的其他工作。第六条 技术审评机构职责国家食品药品监督管理总局保健食品技术审评机构负责申请注册的保健食品的技术审评等工作。主要职责：（一）制定保健食品注册技术审评工作规程；eelings survey, by look

14、i ng uppubli cse ntiments tofi ndpr obl ems. Pr oblems will increase its special supervisi on, set up accounts, hol d on to it.We shoul d conscie ntiouslyimpleme ntthe lea ding contra cting matters,se cured,ha d ananswer to everything,then settlesrateof 100%. Have an im pact onsomeofthe outsta ndi n

15、g issues, supervisi on department s and information componentstogethe r,playt he supervi sory rol eofthe newsme dia to promotepr obl emsolvi ng.Inve stee3.i nsist ona daily run,around the practi ce oftruth catchingefficie ncy,focusspe cification.Togive fullplayto thepartyOfficearound connecting,coor

16、dinating i nternala ndex ter nalfeatures, contact, rallyatalllevels,to motivateeverya spect,adhere to t hetrut h,strengt heni ng standardized management to a chieve coherent, efficient andeffectivefunctioningofthe da ilywork ofthe PartyCommittee.Isprocessing messages should strive to streamline,stan

17、dardizeand quality.Streamlining istocontrolthe numberofthe problem.The pur poseofsupervi sion,toresolve theproblem. To a dher e toand furtherimpr ovetheout city created,a ndcaremasses life,focuswork,i n-dept hinvestigation,moreout bouti quemaster pie ce, makesweofrese arch re sults mor etointole d o

18、f decisi onvi sion,more to i n nati onalsome ha s effectofnewspaperShangpublished,fora dvance work, and publicity changde play dueofrole.Third,information submittedto be pragmati c. Quicka ndtimel y.T he ancients said:forthe timesystem;statement backfort he time bei ng, nothi ng.Therefore,thesubmi s

19、sion ofinformation to do "four",that is,findthe problemfaster,editorialwriting,se nd and rea dfaster appr ovaland feedba ck toimplementquickl y.Tobet ue and accurate.True mainlyreflect thefull picture ofevents,oneis one ,two,thi s isthe life oftheinformation.Accuracyis primarily qualitativ

20、ea nd qua ntitativeque stions,quantitative obje ctiveofpubli cQualitative logi c.To be reliablea nd useful.Wesubmit informationto haveaccesst o de cisoin-making,tog uide and promote t he work a nd solve practica lproblems. Mixedcum.Onthe negative informationa nd emerge ncyi nformation,ra pide scalat

21、i on instrict a ccorda nce withthe procedures,firm,newspaper, ne wspa pers, neverlate,failto re port,false claim a nd skimmi ng.Investe e2.supervision andinsiston, around a nd pr otect ng theiri nterests to touchthe tr uth, see k practicalre sults.Adhere to people -orie nted,themostimportant thing i

22、s to re alize, safeguard a nd developthef undamentalintere sts ofthe overwhelming majority ofthe people.Wecarry out inspe ction,so must go dee pamongt he masses,go dee p intot he realitie s,always payattention to the people's livel ihood,tograsp t he publ ic sentiment,a nd e arnestly safeguardt

23、he be nefit,addressi ng themasses arem ostconcerne d about a nd refle ctingthe stronge st issues,effortsto solve t hepr oblem ofdeci sionsimpl emented a nd not implemented. One istostick to principl es. Rightof i nspecti on is oneofthemost importantpowersofthe Office,should not only dare to use, but

24、 alsowith cauti on.So -calle ddared to use, i stoholda numberofimportant issue s, bold supervisi on ov ersupervisi on,tra ckinspe ction, problemsare notsolved do not pass,the blame does not hold did notmiss, dissatisfaction ofthemasses did notmiss,the realrightofsupervision authority, with t he bene

25、fits.Callwit h ca ution, is supervisi ng de partments shouldstrengthen the consci ousne ssofaut horizedstrictlya ccordi ng topr oce dure, preventi ng thesupervi sion andexcessiveto preventadding burde n to grass -roots.Tothi s end, the supervisi on De partmentofthe Party Committeeofsupervision mustb

26、eunder cityandCountypartyCommitteeSecretary-General（Office）.Second,weshould focuson.Isthe Governor, those relate dtothe gl obalEve nt,Gover northe protra cted difficult,strongGover nor duri ngemergency urgent. Not havi ng special departments in charge ofthe Ge neralGover nor,undert he normalproce du

27、re can do g ood thing s not Governor, not a uthorized by Countylea ders, notthe Gover nor. Third i s tosolve（二）组织开展保健食品研发报告、产品配方、生产工艺、安全性、保健功能、标签、说明书等方面的技术审评工作，并作出综合性技术审评意见和结论；（三） 承担技术审评专家和技术人员的管理以及技术审评意见的审核工作，对技术审评专家和技术人员的工作进行规范、指导和监督；（四）组织开展相关现场核查、抽样和复核性检验工作；（五）承担保健食品技术审评、备案相关的其他技术工作。第七条 专家职责技术审评专

28、家和技术人员在审评过程中应当依据国家有关规定开展技术审评工作，遵守利益冲突回避原则，对提出的审评意见负责。第八条 申请人和备案人义务申请人或备案人应当对申请注册和备案的保健食品的安全性、保健功能和质量可控性负责，承担相应法律责任。主要义务：（一）建立与产品研制、生产有关的质量管理体系，并保持有效运行；（二）保证生产研制和研究论证过程规范，所有数据真实、完整和可溯源；（3） 办理保健食品注册或者备案事务的人员应当具有相应的专业知识，熟悉保健食品注册或者备案管理的法律、法规、规章和技术要求；（4） 按照规定提交规范完整的申请材料，保证材料具有充分可靠的研究数据和科学依据， 材料能够支持产品的安全性

29、、保健功能和质量可控性，并对材料实质内容的真实性负责；（5） 按照要求协助开展与注册或备案相关的现场核查、抽样、复核性检验和监督检查等工作。第九条 检验机构义务国家食品药品监督管理总局遴选的保健食品检验机构承担保健食品技术审查评价所需的复核性检验工作，并遵守利益冲突回避原则，检验机构和检验人对出具的复核检验报告和结论负责。第十条 申请材料目录和示范文本公示食品药品监督管理部门应当将保健食品注册和备案的事项、依据、条件、 程序、期限以及需要提交的全部材料的目录和申请书示范文本等在行政机关的网站和办公场所公示。第十一条遵循原则保健食品的注册与备案工作，应当遵循科学、公正、公开、高效、 便民的原则。

30、对于保健食品注册和备案的依据和结果，食品药品监督管理部门应当公开。第十二条保密义务食品药品监督管理部门、技术审评机构、检验机构以及其他参与保健食品注册与备案工作的单位和个人，应当对注册或者备案中获知的企业商业秘密予以保密。第十三条社会监督任何单位和个人对保健食品产品研制、注册检验、受理、技术审评、行政审批等工作中发现的违法违规行为，有权向食品药品监督管理部门举报。食品药品监督管理部门应当及时核实处理。第二章保健食品注册-II.ovethe service, improvethe quality. III 一 一amclosed, eheI -daily worw orkofthe other

31、Office System.Confidential一 J - .一 , I 一一 一 一I. _ . , _ I _>.11_ L . -.adership emer gedfrom theGecy managemecurityteeelings survey,by looki ng uppubli cse ntiments tofindpr obl ems. Pr oblems will increase its special supervisi on, set up accounts,hold on to it.Weshoul d conscie ntiouslyimplemen

32、tthe lea ding contra cting matters,secured,ha d ananswer to everything,then settlesrateof100%. Have an impactonsomeoftheoutsta ndi ng issues, supervisin department s and information componentstogethe r,playt he supervi sory rol eofthe newsme dia to promotepr obl emsolvi ng.Inve stee3.i nsist ona dai

33、ly run,around thepracti ce oftruth catchingefficie ncy,focusspecification.TTogive fullplayto thenating i nternalandex ter nalfeatures,contact, rallyatalllevels,to motivateeveryaspect,adhere to thetruth,strengt heni ng standardized managefficient andeffectivefunctioningk ofthe PartyCommittee.Iss,redu

34、ci ng procedures, improve messag eha ndli ng efficiency. S pecifications,is to strictly enforcethe ba n issued by theCommuniprocessi ng, itis necessary to accuratelyimplementingthe i ntention of the PartyCommittee,clearance, goodcommunications,policy pr ogramcnsuring thatt here is no error.Second me

35、etingscheduledtoensure thoroug h,safe a nd efficie nt.Any arrangements for themeetingsa ndeve nts,carefully arranged, itemnted, sure. o vigor ouslystreamlinemeetineral Conference andentertainmentservices,focus on bigthings,matters.Third,re cepti on serviceshould lay stress on humaenforceme nt, ensur

36、ethe san.Reception and work directly with people, re cepti on services directlyaffecting tfidentialworkto meetthe demands of newtechnology develo pmenthe Office ofpartyhumaneatmosphere,and constantly improfservi ce.M eanw hile,t ofurtherpayspecialattention toI -.L. Ill. .11. - I - . 一 work re sponsi

37、bilitysy stem for leadi ng ca dresto implementsecurity as aleade r,to improvet heconfidentialityofclassified personnel,especi ally leadi ng ca dres, strengthening party a ndGovernment standar dization, modernizationofsechniquesa sa mea ns ofa dministrationaccor.L . I -一- -ding t olawa nd securitythe

38、 problem.The pur poseofsupervi sion,toresolve theproblem. To a dher e toand furtherimpr ovetheout city created,a ndcaremasses life,focuswork,i n-dept hinvestigation,moreout bouti quemaster pie ce, makesweofrese arch re sultsmor etointole d of decisi onvi sion,more to i n nati onals omeha s effectofn

39、ewspaperShangpublished,fora dvance work, and publicity changde play dueofrole.Third,information submitted tobe pragmati c. Quicka ndtimel y.The ancients said:forthe timesystem;statement backfort he time bei ng, nothi ng.Theref ore,the submi ssion ofinformation to do "four",that is,findthe

40、problemfaster,editorialwriting,se nd and rea dfaster appr ovaland feedba ck toimplementquickl y.Tobetr ue and accurate.True mainlyreflect thefull picture ofevents,oneis one, two,thi s isthe life oftheinformation.Accuracy isprimarily qualitativea nd qua ntitativeque stions,quantitativeobje ctiveofpub

41、li cQualitative logi c.To be reliablea nd useful.Wesubmit inform ation to haveaccesst o de cisi on -making, to g uide and promote t he work a nd solve practica lproblems. Mixedcum.Onthe negative informationa nd emerge ncyi nformation,ra pide scalati on instrict a ccorda nce withthe procedures,firm,n

42、ewspaper, ne wspa pers, neverlate,failto re port,false claim a nd skimmi ng.Investe e2.supervision andinsiston, around a nd pr otecting theiri nterests to touchthe tr uth, see k practicalre sults.Adhere to people -orie nted,themostimportant thing is to re alize, safeguard a nd developthef undamental

43、intere sts ofthe overwhelming majorityofthe people.Wecarry out inspe ction,so must go dee pamongt he masses,go dee p intot he realitie s,always payattention to thepeople'slivel ihood,tograsp t he publ ic sentiment,a nd e arnestly safeguardt he be nefit,addressi ng themasses arem ostconcerne d ab

44、out a nd refle ctingthe stronge st issues,effortsto solve t hepr oblem ofdeci sionsimpl emented a nd not implemented. One istostick to principl es. Rightof i nspecti on is oneofthemost importantpowersofthe Office,should not only dare to use, but alsowith cauti on. So-calle ddared to use, i stoholda

45、numberofimportant issue s, bold supervisi on ov ersupervisi on,tra ckinspe ction, problemsare notsolved do not pass,the blame does not hold did notmiss, dissatisfaction ofthemasses did notmiss,the realrightofsupervision authority, with the benefits. Callwit h ca uti on, is supervisi ng de partments

46、shouldstre ngthe n the consci ousne ssofaut horizedstrictlya ccordi ng toproce dure, preventi ng thesupervi sion andexcessiveto preventadding burde n to grass-roots.Tothi s end, the supervisi on De partmentofthe Party Committeeofsupervision mustbeunder cityandCountypartyCommittee Secretary-General(O

47、ffice).Second,we should focuson. Isthe Governor, those relate dtothe gl obalEve nt,Gover northe protra cted diff icult,strong Gover nor duri ngemergency urgent. Not havi ng special departments in charge ofthe Ge neralGover no r,undert he normalproce dure can do g ood thing s not Governor, not a utho

48、rized by Countylea ders, notthe Gover nor. Third i s tosolve第一节注册要求第十四条注册范围保健食品注册申请范围包括：（一）使用保健食品原料目录以外的原料生产经营保健食品的；（二）首次进口的保健食品。第十五条申请人资质保健食品注册，申请人应当具备以下条件：（一） 申请注册国产保健食品的，应当是中国境内合法登记的法人或者其他组织；申请注册进口保健食品的，应当是上市产品的合法持有人；（二）两个以上单位共同研发的保健食品，应当由其中的一个单位申请注册。第十六条注册申请材料要求保健食品注册应当提交以下材料：（一）保健食品注册申请表；（二）申请人

49、有效的合法登记证明文件及其复印件；（三）申请注册保健食品的通用名称与已经批准注册的药品名称不重名的检索材料；（四）产品研发材料，内容主要包括研发时间、研发过程、研发依据、研发数据及研发人信息，申请人生产研发行为及申请材料不构成侵权的法律责任承诺书；（五）产品配方材料，内容主要包括配方及配伍用量依据，原料和辅料的合法来源、使用依据、检验合格证明以及原料鉴定报告等；（6） 产品工艺材料，内容主要包括生产工艺流程简图及说明，关键工艺控制点及说明。直接接触产品的包装材料的种类、名称、质量标准及选择依据等；（7） 产品安全性和保健功能评价材料，内容主要包括安全性和保健功能试验评价材料，人群食用评价材料，

50、功效成分或标志性成分试验报告，卫生学试验报告，稳定性试验报告、菌种毒力试验报告以及涉及兴奋剂、违禁药物成分的检测报告等；产品安全性、保健功能复核性检验的具体试验方法（明确样品前处理方法和检验周期）以及详细说明和相关研究材料等内容；（八）产品技术要求材料，内容主要包括感官要求，鉴别，理化指标、微生物指标、功效成分或标志性成分含量及测定方法（明确样品前处理方法及检验周期），生产工艺流程、关键工艺控制点，原辅料标准和来源等，以及详细说明和相关研究材料等内容；（九）产品标签、说明书样稿材料，主要包括原料、辅料、功效成分或标志性成分及含量、适宜人群、不适宜人群、保健功能、食用量及食用方法、规格、贮藏方法

51、、保质期、注意事项等内容及相关制定依据和说明；（十）全面分析产品安全性、保健功能及质量可控性的综述报告及相关科学依据；（十一）三个未启封的保质期内的最小销售包装样品；（十二）其他有助于产品审评的材料。第十七条首次进口产品注册材料要求申请首次进口保健食品注册的，应当提交本办法第十六条（二）项外的材料，并补充提交以下材料：（1） 所在国家（地区）主管部门出具的申请人为上市产品合法持有人的资质证明文件eelings survey, by looki ng uppubli cse ntiments tofi ndpr obl ems. Pr oblems will increase its speci

52、al supervisi on, set up accounts, hol d on to it.We shoul d conscie ntiouslyimpleme ntthe lea ding contra cting matters,se cured,ha d ananswer to everything,then settlesrateof 100%. Have an im pact onsomeofthe outsta ndi ng issues, supervisi on department s and information componentstogethe r,playt

53、he supervi sory rol eofthe newsme dia to promotepr obl emsolvi ng.Inve stee3.i nsist ona daily run,around the practi ce oftruth catchingefficie ncy,focusspe cification.Togive fullplayto thepartyOfficearound connecting,coordinating i nternala ndex ter nalfeatures, contact, rallyatalllevels,to motivat

54、eeverya spect,adhere to t hetrut h,strengt heni ng standardized management to a chieve coherent, efficient andeffectivefunctioningofthe da ilywork ofthe PartyCommittee.Isprocessing messages should strive to streamline,standardizeand quality.Streamlining istocontrolthe numberofout city created,a ndca

55、remasses life,focuswork,i n-dept hinvestigation,moreout bouti quemaster pie ce, makesweofrese arch re sults mor etointole d of decisi onvi sion,more to i n nati onalsome ha s effectofnewspaperShangpublished,fora dvance work, and publicity changde play dueofrole.Third,information submittedto be pragm

56、ati c. Quicka ndtimel y.T he ancients said:forthe timesystem;statement backfort he time bei ng, nothi ng.Therefore,thesubmi ssion ofinformation to do "four",that is,findthe problemfaster,editorialwriting,se nd and rea dfaster appr ovaland feedba ck toimplementquickl y.Tobet ue and accurate

57、.True mainlyreflect thefull picture ofevents,oneis one ,two,thi s isthe life oftheinformation.Accuracyis primarily qualitativea nd qua ntitativeque stions,quantitative obje ctiveofpubli cQualitative logi c.To be reliablea nd useful.Wesubmit informationto haveaccesst o de cisoin-making,tog uide and p

58、romote t he work a nd solve practica lproblems. Mixedcum.Onthe negative informationa nd emerge ncyi nformation,ra pide scalati on instrict a ccorda nce withthe procedures,firm,newspaper, ne wspa pers, neverlate,failto re port,false claim a nd skimmi ng.Investe e2.supervision andinsiston, around a nd pr otect ng theiri nterests to touchth