疫苗行业相关标准

-.z.序号标准号名称中国行业标准SC1001-1992草鱼出血病组织浆灭活疫苗SC7701-2007草鱼出血病细胞培养灭活疫苗SN/T1306-2021入出境人员疫苗接种或预防措施国际证书签发规程YY0573.3-2005一次性使用无菌注射器第3局部：自毁型固定剂量疫苗注射器A群C群脑膜炎球菌多糖疫苗GroupAandCMeningococcalPolysaccharideVaccineA群脑膜炎球菌多糖疫苗GroupAMeningococcalPolysaccharideVaccineb型流感嗜血杆菌结合疫苗HaemophilusInfluenzaeTypebConjugateVaccine白喉抗毒素DiphtheriaAntito*in冻干白喉抗毒素DiphtheriaAntito*in，Freezedried冻干多价气性坏疽抗毒素GasgangreneAntito*in〔Mi*ed〕，Freezedried冻干甲型肝炎减毒活疫苗HepatitisAVaccine〔Live〕，Freeze-dried冻干静注人免疫球蛋白〔pH4〕HumanImmunoglobulin〔pH4〕forIntravenousInjection，Freeze-dried冻干狂犬病人免疫球蛋白HumanRabiesImmunoglobulin，Freeze-dried冻干破伤风抗毒素TetanusAntito*in，Freezedried冻干破伤风人免疫球蛋白HumanTetanusImmunoglobulin，Freeze-dried冻干人免疫球蛋白HumanImmunoglobulin，Freezedried冻干人血白蛋白HumanAlbumin，Freezedried冻干人用狂犬病疫苗〔Vero细胞〕RabiesVaccineforHumanUse〔Verocell〕，Freeze-dried冻干肉毒抗毒素BotulinumAntito*ins，Freezedried冻干乙型肝炎人免疫球蛋白HumanHepatitisBImmunoglobulin，Freeze-dried冻干乙型脑炎灭活疫苗〔Vero细胞〕JapaneseEncephalitisVaccine〔VeroCell〕，Inactivated，Freeze-dried多价气性坏疽抗毒素GasgangreneAntito*in〔Mi*ed〕风疹减毒活疫苗〔人二倍体细胞〕RubellaVaccine〔HumanDiploidCell〕，Live风疹减插活疫苗〔兔肾细胞〕RubellaVaccine〔R!bbitKidneyCedl〕，Live钩端螺旋体疫苗LeptospiraVaccine口服脊髓灰质炎减毒活疫苗〔猴肾细胞〕Poliomyelitis〔Live〕Vaccine〔MonkeyKidneyCell〕，Oral脊髓灰质炎减毒活疫苗糖丸〔人二倍体细胞〕PoliomyelitisVaccineinDrageeCandy〔HumanDiploidCell〕，Live甲型肝炎灭活疫苗〔人二倍体细胞〕HepatitisAVaccine〔HumanDiploidCell〕，Inactivated甲乙型肝炎联合疫苗HepatitisAandBbinedVaccine结核菌素纯蛋白衍生物PurifiedProteinDerivativeofTuberculin〔TB－PPD〕静注人免疫球蛋白〔pH4〕HumanImmunoglobulin〔pH4〕forIntravenousInjection卡介菌纯蛋白衍生物PurifiedProteinDerivativeofBCG〔BCG－PPD〕抗狂犬病血清RabiesAntiserum抗人T细胞兔免疫球蛋白Anti-humanTLymphocyteRabbitImmunoglobulin抗人T细胞猪免疫球蛋白Anti-humanTLymphocytePorcineImmunoglobulin抗炭疽血清Anthra*Antiserum口服福氏宋内菌痢疾双价活疫苗DysenteryVaccine〔Live〕ofS.fle*neriandS.sonnei，Oral脊髓灰质炎减毒活疫苗糖丸〔猴肾细胞〕PoliomyelitisVaccineinDrageeCandy〔MonkeyKidneyCell〕，live狂犬病人免疫球蛋白HumanRabiesImmunoglobulin流感病毒裂解疫苗InfluenzaVaccine〔SplitVirion〕，Inactivated流感全病毒灭活疫苗InfluenzaVaccine〔WholeVirion，Inactivated〕麻腮风联合减毒活疫苗Measles，MumpsandRubellabinedVaccine，Live麻疹风疹联合减毒活疫苗MeaslesandRubellabinedVaccine，Live麻疹减毒活疫苗MeaslesVaccine，Live麻疹腮腺炎联合减毒活疫苗MeaslesandMumpsbinedVaccine，Live皮内注射用卡介苗BCGVaccineforIntradermalInjection皮上划痕人用布氏菌活疫苗BrucellosisVaccine〔Live〕forPercutaneousScarification皮上划痕人用炭疽活疫苗Anthra*Vaccine〔Live〕forPercutaneousScarification皮上划痕用鼠疫活疫苗PlagueVaccine〔Live〕forPercutaneousScarification破伤风抗毒素TetanusAntito*in破伤风人免疫球蛋白HumanTetanusImmunoglobulin人免疫球蛋白HumanImmunoglobulin人凝血酶原复合物HumanProthrombinple*人凝血因子ⅧHumanCoagulationFactorⅧ人纤维蛋白原HumanFibrinogen人血白蛋白HumanAlbumin人用狂犬病疫苗〔Vero细胞〕RabiesVaccineforHumanUse〔VeroCell〕人用狂犬病疫苗〔地鼠肾细胞〕RabiesVaccineForHumanUse〔PHKCell〕肉毒抗毒素BotulinumAntito*ins腮腺炎减毒活疫苗MumpsVaccine，Live森林脑炎灭活疫苗Tick-borneEncephalitisVaccine，Inactivated伤寒Vi多糖疫苗ViPolysaccharideTyphoidVaccine伤寒甲型副伤寒联合疫苗TyphoidandParatyphoidAbinedVaccine伤寒甲型乙型副伤寒联合疫苗TyphoidandParatyphoidA&BbinedVaccine伤寒疫苗TyphoidVaccine双价肾综合征出血热灭活疫苗〔Vero细胞〕双价肾综合征出血热灭活疫苗〔地鼠肾细胞〕HaemorrhagicFeverwithRenalSyndromeBivalentVaccine〔HamsterKidneyCell〕，Inactivated双价肾综合征出血热灭活疫苗〔沙鼠肾细胞〕HaemorrhagicFeverwithRenalSyndromeBivalentVaccine〔GerbilKidneyCell〕，Inactivated外用重组牛碱性成纤维细胞生长因子RebinantBovineBasicFibroblastGrowthFactorforE*ternalUse外用重组人表皮生长因子RebinantHumanEpidermalGrowthFactorforE*ternalUse吸附白喉破伤风联合疫苗DiphtheriaandTetanusbinedVaccine，Adsorbed吸附白喉破伤风联合疫苗〔成人及青少年用〕DiphtheriaandTetanusbinedVaccineforAdultsandAdolescents，Adsorbed吸附白喉疫苗DiphtheriaVaccine，Adsorbed吸附白喉疫苗〔成人及青少年用〕DiphtheriaVaccineforAdultsandAdolescents，Adsorbed吸附百白破联合疫苗Diphtheria，TetanusandPertussisbinedVaccine，Adsorbed吸附百日咳白喉联合疫苗DiphtheriaandPertussisbinedVaccine，Adsorbed吸附破伤风疫苗TetanusVaccine，Adsorbed吸附无细胞百白破联合疫苗Diphtheria，TetanusandAcellularPertussisbinedVaccine，Adsorbed锡克试验毒素SchickTestTo*in乙型肝炎人免疫球蛋白HumanHepatitisBImmunoglobulin乙型脑炎减毒活疫苗JapaneseEncephalitisVaccine，Live重组人白介素-2注射液RebinantHumanInterleukin-2Injection重组人促红素注射液〔CHO细胞〕RebinantHumanErythropoietinInjection〔CHOCell〕重组人干扰素α2a注射液RebinantHumanInterferonα2aInjection重组人干扰素α2b注射液RebinantHumanInterferonα2bInjection重组人干扰素α2b注射液〔假单胞菌〕RebinantHumanInterferonα2bInjection〔P.putida〕重组人粒细胞刺激因子注射液RebinantHumanGranulocyteColonystimulatingFactorInjection重组乙型肝炎疫苗〔CHO细胞〕HepatitisBVaccineMadebyRebinantDNATechniquesinCHOCell重组乙型肝炎疫苗〔酿酒酵母〕HepatitisBVaccineMadebyRebinantDNATechniquesinSaccharomycesCerevisciaeYeast注射用A型肉毒毒素BotulinumTo*inTypeAforInjection注射用抗人T细胞CD3鼠单抗MouseMonoclonalAntibodyagainstHumanCD3AntigenofTLymphocyteforInjection、注射用重组链激酶RebinantStreptokinaseforInjection注射用重组人白介素-2RebinantHumanInterleukin-2forInjection注射用重组人促红素〔CHO细胞〕RebinantHumanErythropoietinforInjection〔CHOCell〕注射用重组人干扰素α1bRebinantHumanInterferonα1bforInjection注射用重组人干扰素α2aRebinantHumanInterferonα2aforInjection注射用重组人干扰素α2a〔酵母〕RebinantHumanInterferonα2aforInjection〔Yeast〕注射用重组人干扰素α2bRebinantHumanInterferonα2bforInjection注射用重组人干扰素α2b〔假单胞菌〕RebinantHumanInterferonα2bforInjection〔P.putida〕注射用重组人干扰素2b〔酵母〕RebinantHumanInterferon2bforInjection〔Yeast〕注射用重组人干扰素γRebinantHumanInterferonγforInjection注射用重组人粒细胞巨噬细胞刺激因子RebinantHumanGranulocyte/MacrophageColony-stimulatingFactorforInjection生物制品包装规程生物制品分批规程生物制品分装和冻干规程生物制品国家标准物质制备和标定规程生物制品生产和检定用动物细胞基质制备及检定规程生物制品生产检定用菌毒种管理规程免疫血清生产用马匹检疫和免疫规程生物制品质量控制分析方法验证技术审评一般原则生物制品贮藏和运输规程疫苗流通和预防接种管理条例疫苗储存和运输管理标准治疗用生物制品非临床平安性技术审评一般原则中国生物制品主要原辅材料质控标准中国地方标准DB37/T1210-2021猪繁殖与呼吸综合征油乳剂灭活疫苗〔SD1株〕免疫技术标准DB43/T371-2007鱼类嗜水气单胞菌灭活疫苗制作规程DB21/T1764-2021兽用疫苗冷链建立技术与管理标准DB45/T588-2021水产养殖鱼类细菌病组织浆疫苗制备与应用标准DB23/T888-2005兽用疫苗贮存、运输和使用标准DB35/T989-2021猪瘟活疫苗原料兔WHO标准TRS(TechnicalReportSeries)No.745Requirementsfordriedbcgvaccine,Anne*2冻干卡介苗质量要求，附录2TRSNo.771RequirementsfordriedBCGvaccine,Anne*12冻干卡介苗质量要求，附录12TRSNo.924Guidelinesfortheproductionandcontrolofinactivatedoralcholeravaccine,Anne*3灭活口服霍乱疫苗的生产和质量控制指南，附录3TRSNo.932Guidelinesfortheproductionandqualitycontrolofcandidatetetravalentdenguevirusvaccines(live),Anne*1备选四价登革病毒疫苗的生产和质量控制指南，附录1TRSNo.927RemendationsforDTPandbinedvaccines,Amendments2003,Anne*5百白破和联合疫苗建议，2003年修正版，附录5TRSNo.800RequirementsforDTP,Anne*2百白破疫苗质量要求，附录2TRSNo.941Guidelinesforassuringthequalityandnon-clinicalsafetyevaluationofDNAvaccines,Anne*1DNA疫苗的非临床平安评价和质量确认指南，附录1TRSNo.848Requirementsforhaemorrhagicfeverwithrentalsyndrome(HFRS)vaccine(inactivated),Anne*2肾综合症出血热疫苗〔灭活〕的质量要求，附录2TRSNo.897RemendationsfortheproductionandcontrolofHaemophilusinfluenzaetypebconjugatevaccines,Anne*1B型流感嗜血杆菌结合疫苗的生产和控制建议，附录1TRSNo.858RequirementsforhepatitisAvaccines(inactivated),Anne*2甲型肝炎疫苗〔灭活〕质量要求，附录2TRSNo.771RequirementsforheptatitisBvaccinepreparedfromplasma,Anne*8由血浆制备的乙型肝炎疫苗的质量要求，附录8TRSNo.786TRSNo.889Remendationstoassurethequality,safetyandefficacyofrebinanthepatitisBposedreplacementof:LTRS786,Anne*2andTRS889,Anne*4重组乙肝疫苗的质量、平安和效力确认建议〔建议由TRS786附录2和TRS889附录4代替〕WHO/BS/06.2050Guidelinestoassurethequality,safetyandefficacyofrebinanthumanpapillomavirusvirus-likeparticlevaccines重组人乳头瘤病毒病毒样颗粒疫苗的质量、平安和效力确认指南TRSNo.927Remendationsfortheproductionandcontrolofinfluenzavaccine(inactivated),Anne*3灭活流感疫苗的生产和控制建议，附录3WHO/IMD/PUB/04.1WHOremendationstoassurethequality,safetyandefficacyofinfluenzavaccines(human,liveattenuated)forintranasaladministrationWHO对鼻腔给药人类减活流感疫苗的质量、平安和效力确认的建议TRSNo.941WHObiosafetyriskassessmentandguidelinesfortheproductionandqualitycontrolofhumaninfluenzapandemicvaccines,Anne*5WHO对人类流感疫苗的生产和质量控制的指南和生物平安风险评价，附录5TRSNo.941H1N1specific-updateofTRS941,Anne*5对与H1N1的TRS941的细节更行，附录5WHO/BS/07.2074Proposedguidelines:regulatorypreparednessforhumanpandemicinfluenzavaccines人类流感疫苗的监管准备的建议指南WHO/BS/07.20644ProposedrevisionremendationsforJapaneseencephalitisvaccine(inactivated)forhumanuse人用灭活乙型脑炎疫苗的修正建议TRSNo.910GuidelinesfortheproductionandcontrolofJapaneseencephalitisvaccine(live)forhumanuse,Anne*3人用活乙型脑炎疫苗的生产和控制指南，附录3TRSNo.840Requirementsformeasles,mumpsandrubellavaccinesandbinedvaccine(live),Anne*3麻疹、流行性腮腺炎、风疹疫苗和活麻腮风联合疫苗的质量要求，附录3WHO/BS/06.2041Remendationstoassurethequality,safetyandefficacyofgroupameningococcalconjugatevaccinesA群脑膜炎球菌结合疫苗的质量、平安和效力确认建议TRSNo.924RemendationsfortheproductionandcontrolofMeningococcalgroupCconjugatevaccines,Anne*2C群脑膜炎球菌结合疫苗的生产和控制建议，附录2TRSNo.926RemendationsfortheproductionandcontrolofgroupCmeningococcalconjugatevaccines,Addendum2003,Anne*3C群脑膜炎球菌结合疫苗的生产和控制建议，2003年附件的附录2WHO/BS/07.2065ClinicalevaluationofgroupCmeningococcalconjugatevaccinesC群脑膜炎球菌结合疫苗的临床平安评价TRSNo.904Requirementsformeningococcalpolysaccharidevaccine(Amendment1999),Anne*2脑膜炎球菌多糖疫苗质量要求〔1999年修正〕，附录2TRSNo.658Requirementsformeningococcalpolysaccharidevaccine,Addendum1980,Anne*6脑膜炎球菌多糖疫苗质量要求〔1999年修正〕，1980附件附录2TRSNo.594Requirementsformeningococcalpolysaccharidevaccine:Adopted1975,Anne*2脑膜炎球菌多糖疫苗质量要求，1975年被采用，附录2TRSNo.848NOTE:requirementsformeasles,mumpsandrubellavaccinesandbinedvaccine(live)(requirementsforbiologicalsubstancesNO.47)说明：麻疹、流行性腮腺炎、风疹疫苗和活麻腮风联合疫苗的质量要求〔生物物质NO.47质量要求〕TRSNo.941Remendationsforwholecellpertussisvaccine,Anne*6全细胞百日咳疫苗建议，附录6TRSNo.800Requirementsfordiphtheria,tetanus,pertussisandbinedVaccines,Anne*2百白破联合疫苗质量要求，附录2TRSNo.927Remendationsfordiphtheria,tetanus,pertussisandbinedVaccines,Amendment2003,Anne*5百白破联合疫苗建议，2003年修正，附录5TRSNo.878Guidelinesfortheproductionandcontroloftheacellularpertussisponentofmonovalentorbinedvaccines,Anne*2无细胞百日咳单价或联合疫苗的生产和控制指南，附录2TRSNo.927Remendationstoassurethequality,safetyandefficacyofpneumococcalconjugatevaccines-proposedreplacementofTRS927,Anne*2肺炎球菌结合疫苗的质量、平安和效力确认建议〔由TRS927代替〕，附录2TRSNo.926Guidelinesforthesafeproductionandqualitycontrolofinactivatedpoliomyelitisvaccinemanufactureredfromwildpolioviruses(Addendum2003toremendationsfortheproductionandqualitycontrolofpoliomyelitisvaccine(Inactivated)),Anne*2从野生脊髓灰质炎病毒生产的脊髓灰质炎灭活疫苗的生产和质量控制指南〔灭活脊髓灰质炎疫苗的生产和质量控制建议的2003年附件〕，附录2TRSNo.910Remendationsfortheproductionandcontrolofpoliomyelitisvaccine(Inactivated),Anne*2灭活脊髓灰质炎疫苗的生产和控制建议，附录2TRSNo.910Remendationsfortheproductionandcontrolofpoliomyelitisvaccine(oral)(Addendum2000),Anne*1口服脊髓灰质炎疫苗的生产和控制建议〔2000年附件〕，附录2TRSNo.904Remendationsfortheproductionandcontrolofpoliomyelitisvaccine,oral;Revised1999,Anne*1口服脊髓灰质炎疫苗的生产和控制建议，1999年修正，附录1TRSNo.941Remendationsforinactivatedrabiesvaccineforhumanuseproducedincellsubstratesandembryonatedeggs,Anne*2在细胞基质和鸡胚中生产的人用灭活狂犬病疫苗建议，附录2TRSNo.658Requirementsforrabiesvaccineforhumanuse,Revised1980,Anne*2人用狂犬病疫苗质量要求，1980年修正，附录2TRSNo.673Requirementsforriftvalleyfevervaccines;Adopted1981,Anne*4裂谷热疫苗的质量要求，1981年采用，附录4TRSNo.941Guidelinestoassurethequality,safetyandefficacyofliveattenuatedrotavirusvaccines(oral),Anne*3口服减活轮状病毒疫苗的质量、平安和效力确认指南，附录3TRSNo.840Requirementsformeasles,mumpsandrubellavaccinesandbinedvaccines,live,Anne*3麻疹、流行性腮腺炎、风疹疫苗和麻腮风联合疫苗的质量要求，附录3TRSNo.926Remendationsfortheproductionandqualitycontrolofsmallpo*vaccines,Anne*1天花疫苗的生产和质量控制建议，附录1TRSNo.889Guidelinesfortheproductionandqualitycontrolofsyntheticpeptidevaccines;Adopted1997,Anne*1合成肽疫苗的生产和质量控制指南，1997年采用，附录1TRSNo.880Requirementsfordiphteria,tetanus,pertussisandbinedvaccines,Anne*2百白破联合疫苗的质量要求，附录2TRSNo.927Remendationsfordiphtheria,tetanus,pertussisandbinedvaccines,Amendments2003,Anne*5百白破联合疫苗建议，2003年修正，附录5TRSNo.889Requirementsfortick-borneencephalitisvaccine(inactivated),Adopted1997,Anne*2灭活森林脑炎病毒疫苗的质量要求，1997年采用，附录2TRSNo.840Requirementsforvipolysaccharidetyphoidvaccine;Adopted1992,Anne*1伤寒Vi多糖疫苗的质量要求，1992年采用，附录1TRSNo.361Requirementsfortyphoidvaccine;Adopted1966,Anne*4伤寒疫苗质量要求，1996年采用，附录4TRSNo.700Requirementsfortyphoidvaccine(Live,attenuated,Ty21a,oral),Anne*3伤寒疫苗质量要求〔口服减毒活Ty21a株〕，附录3TRSNo.848Requirementsforvaricellavaccine(Live);Revised1993,Anne*1活水痘疫苗质量要求，1993年修正，附录1TRSNo.872Remendationstoassurethequality,safetyandefficacyofliveattenuatedyellowfevervaccines.黄热病减毒活疫苗的质量、平安和效力确认建议。TRSNo.786Requirementsforhumaninterferonsfromlymphoblastoidcells,Anne*3从幼成淋巴细胞而来的人类干扰素的质量要求，附录3TRSNo.771RequirementsforhumaninterferonsbyrebinantDNAtechniques,Anne*7利用从组DNA技术生产的人类干扰素的质量要求，附录7Remendationsfortheevaluationofanimalcellculturesassubstratesforthemanufactureofbiologicalmedicinalproductsandforthecharacterizationofcellbanks.动物细胞基质生产生物医药产品和细胞库特性的评价建议TRSNo.924Guidelinesonclinicalevaluationofvaccines:regulatorye*pections,Anne*1疫苗临床评价指南：监管期望，附录1TRSNo.822Biologicalproducts,GMP,Anne*1生物制品，GMP，附录1TRSNo.908WHOe*pertmitteeonspecificationsforpharmaceuticalpreparationsWHO专家委员会药物制剂规则TRSNo.932Guidelinesforindependentlotreleaseofvaccinesbyregulatoryauthorities.监管机构独立批量签发疫苗操作指南TRSNo.927WHOguidelinesonnonclinicalevaluationofvaccines,Anne*1WHO非临床评价疫苗操作指南，附录1TRSNo.822Guidelinesfornationalauthoritiesonqualityassuranceforbiologicalproducts,Anne*2国家管理机构对生物制品的质量保证的监管操作指南TRSNo.858Regulationandlicensingofbiologicalproductsincountrieswithnewlydevelopingregulatoryauthorities,Anne*1各个国家新成立的监管机构对生物制品的管理和许可WHO/BS/06.2049Guidelinesonstabilityevaluationofvaccines疫苗稳定性评价指南TRSNo.530GeneralrequirementsforthesterilityofbiologicalsubstancesRevised1973,Anne*4生物基质灭菌一般要求，1973年修正，附录4TRSNo.926Guidelinesonregulatorye*pectationsrelatedtotheelimination,reductionorreplaceofthiomersalinvaccines,Anne*4疫苗中硫柳汞的去除、减少或者代替相关的监管期望操作指南WHOguidelinesontransmissiblespongiformencephalopathiesinrelationtobiologicalandpharmaceuticalproducts.WHO操作指南：感染性海绵状脑病相关的生物和药物产品美国标准DODA-A-54803-1993influenzavirusvaccine,USP流感病毒疫苗，美国药典GOST15991-1986Liveanthra*vaccineSTIforanimals.Specificatio