号中国行业标准1.SC 1001-1992 草鱼出血病组织浆灭活疫苗2.SC 7701-2007 草鱼出血病细胞培养灭活疫苗3.SN/T 1306-2011 入出境人员疫苗接种或预防措施国际证书签发规程4.YY 0573.3-2005 一次性使用无菌注射器第3部分：自毁型固定剂量疫苗注射器5.A群C群脑膜炎球菌多糖疫苗Group A and C Meningococcal Polysaccharide Vaccine6.A群脑膜炎球菌多糖疫苗Group A Meningococcal Polysaccharide Vaccine7.b型流感嗜血杆菌结合疫苗Haemophilus Influenzae Type b Conjugate Vaccine8.白喉抗毒素Diphtheria Antitoxin9.冻干白喉抗毒素Diphtheria Antitoxin，Freeze dried10.冻干多价气性坏疽抗毒素Gas gangrene Antitoxin（Mixed），Freeze dried11.冻干甲型肝炎减毒活疫苗Hepatitis A Vaccine（Live），Freeze-dried12.冻干静注人免疫球蛋白（pH4）Human Immunoglobulin（pH4）for Intravenous Injection，Freeze-dried13.冻干狂犬病人免疫球蛋白Human Rabies Immunoglobulin，Freeze-dried14.冻干破伤风抗毒素Tetanus Antitoxin，Freeze dried15.冻干破伤风人免疫球蛋白Human Tetanus Immunoglobulin，Freeze-dried16.冻干人免疫球蛋白Human Immunoglobulin，Freeze dried17.冻干人血白蛋白Human Albumin，Freeze dried18.冻干人用狂犬病疫苗（V ero 细胞）Rabies V accine for Human Use（Vero cell），Freeze-dried19.冻干肉毒抗毒素Botulinum Antitoxins，Freeze dried号20.冻干乙型肝炎人免疫球蛋白Human Hepatitis B Immunoglobulin，Freeze-dried21.冻干乙型脑炎灭活疫苗（V ero细胞）Japanese Encephalitis Vaccine（Vero Cell），Inactivated，Freeze-dried22.多价气性坏疽抗毒素Gas gangrene Antitoxin（Mixed）23.风疹减毒活疫苗（人二倍体细胞）Rubella Vaccine（Human Diploid Cell），Live24.风疹减插活疫苗（兔肾细胞）Rubella Vaccine（R!bbit Kidney Cedl），Live25.钩端螺旋体疫苗Leptospira Vaccine26.口服脊髓灰质炎减毒活疫苗（猴肾细胞）Poliomyelitis（Live）Vaccine（Monkey Kidney Cell），Oral27.脊髓灰质炎减毒活疫苗糖丸（人二倍体细胞）Poliomyelitis Vaccine in Dragee Candy （Human Diploid Cell），Live28.甲型肝炎灭活疫苗（人二倍体细胞）Hepatitis A Vaccine（Human Diploid Cell），Inactivated29.甲乙型肝炎联合疫苗Hepatitis A and B Combined Vaccine30.结核菌素纯蛋白衍生物Purified Protein Derivative of Tuberculin （TB－PPD）31.静注人免疫球蛋白（pH4）Human Immunoglobulin（pH4）for Intravenous Injection32.卡介菌纯蛋白衍生物Purified Protein Derivative of BCG （BCG－PPD）33.抗狂犬病血清Rabies Antiserum34.抗人T细胞兔免疫球蛋白Anti-human T Lymphocyte Rabbit Immunoglobulin35.抗人T细胞猪免疫球蛋白Anti-human T Lymphocyte Porcine Immunoglobulin36.抗炭疽血清Anthrax Antiserum号37.口服福氏宋内菌痢疾双价活疫苗Dysentery Vaccine（Live）of S.flexneri and S.sonnei，Oral38.脊髓灰质炎减毒活疫苗糖丸（猴肾细胞）Poliomyelitis Vaccine in Dragee Candy （Monkey Kidney Cell），live39.狂犬病人免疫球蛋白Human Rabies Immunoglobulin40.流感病毒裂解疫苗Influenza Vaccine （Split Virion），Inactivated41.流感全病毒灭活疫苗Influenza Vaccine （Whole Virion，Inactivated）42.麻腮风联合减毒活疫苗Measles，Mumps and Rubella Combined Vaccine，Live43.麻疹风疹联合减毒活疫苗Measles and Rubella Combined Vaccine，Live44.麻疹减毒活疫苗Measles Vaccine，Live45.麻疹腮腺炎联合减毒活疫苗Measles and Mumps Combined Vaccine，Live46.皮内注射用卡介苗BCG Vaccine for Intradermal Injection47.皮上划痕人用布氏菌活疫苗Brucellosis Vaccine （Live）for Percutaneous Scarification48.皮上划痕人用炭疽活疫苗Anthrax V accine （Live）for Percutaneous Scarification49.皮上划痕用鼠疫活疫苗Plague Vaccine （Live）for Percutaneous Scarification50.破伤风抗毒素Tetanus Antitoxin51.破伤风人免疫球蛋白Human Tetanus Immunoglobulin52.人免疫球蛋白Human Immunoglobulin53.人凝血酶原复合物Human Prothrombin Complex54.人凝血因子ⅧHuman Coagulation Factor Ⅷ55.人纤维蛋白原号Human Fibrinogen56.人血白蛋白Human Albumin57.人用狂犬病疫苗（V ero 细胞）Rabies Vaccine for Human Use（Vero Cell）58.人用狂犬病疫苗（地鼠肾细胞）Rabies Vaccine For Human Use（PHK Cell）59.肉毒抗毒素Botulinum Antitoxins60.腮腺炎减毒活疫苗Mumps Vaccine，Live61.森林脑炎灭活疫苗Tick-borne Encephalitis Vaccine，Inactivated62.伤寒Vi多糖疫苗Vi Polysaccharide Typhoid Vaccine63.伤寒甲型副伤寒联合疫苗Typhoid and Paratyphoid A Combined Vaccine64.伤寒甲型乙型副伤寒联合疫苗Typhoid and Paratyphoid A & B Combined Vaccine65.伤寒疫苗Typhoid Vaccine66.双价肾综合征出血热灭活疫苗（Vero细胞）Haemorrhagic Fever with Renal Syndrome Bivalent V accine （V ero Cell），Inactivated67.双价肾综合征出血热灭活疫苗（地鼠肾细胞）Haemorrhagic Fever with Renal Syndrome Bivalent Vaccine （Hamster Kidney Cell ），Inactivated68.双价肾综合征出血热灭活疫苗（沙鼠肾细胞）Haemorrhagic Fever with Renal Syndrome Bivalent Vaccine （Gerbil Kidney Cell ），Inactivated69.外用重组牛碱性成纤维细胞生长因子Recombinant Bovine Basic Fibroblast Growth Factor for External Use70.外用重组人表皮生长因子Recombinant Human Epidermal Growth Factor for External Use71.吸附白喉破伤风联合疫苗Diphtheria and Tetanus Combined Vaccine，Adsorbed72.吸附白喉破伤风联合疫苗（成人及青少年用）Diphtheria and Tetanus Combined Vaccine for Adults and号Adolescents，Adsorbed73.吸附白喉疫苗Diphtheria Vaccine，Adsorbed74.吸附白喉疫苗（成人及青少年用）Diphtheria Vaccine for Adults and Adolescents，Adsorbed75.吸附百白破联合疫苗Diphtheria，Tetanus and Pertussis Combined Vaccine，Adsorbed76.吸附百日咳白喉联合疫苗Diphtheria and Pertussis Combined Vaccine，Adsorbed77.吸附破伤风疫苗Tetanus Vaccine，Adsorbed78.吸附无细胞百白破联合疫苗Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，Adsorbed79.锡克试验毒素Schick Test Toxin80.乙型肝炎人免疫球蛋白Human Hepatitis B Immunoglobulin81.乙型脑炎减毒活疫苗Japanese Encephalitis Vaccine，Live82.重组人白介素-2注射液Recombinant Human Interleukin-2 Injection83.重组人促红素注射液（CHO细胞）Recombinant Human Erythropoietin Injection （CHO Cell）84.重组人干扰素α2a注射液Recombinant Human Interferon α2a Injection85.重组人干扰素α2b注射液Recombinant Human Interferon α2b Injection86.重组人干扰素α2b注射液（假单胞菌）Recombinant Human Interferon α2b Injection （P.putida）87.重组人粒细胞刺激因子注射液Recombinant Human Granulocyte Colony stimulating Factor Injection88.重组乙型肝炎疫苗（CHO细胞）Hepatitis B Vaccine Made by Recombinant DNA Techniques in CHO Cell89.重组乙型肝炎疫苗（酿酒酵母）Hepatitis B Vaccine Made by Recombinant DNA Techniques in Saccharomyces Cerevisciae Yeast90.注射用A型肉毒毒素号Botulinum Toxin Type A for Injection91.注射用抗人T细胞CD3鼠单抗Mouse Monoclonal Antibody against Human CD3 Antigen of T Lymphocyte for Injection92.、注射用重组链激酶Recombinant Streptokinase for Injection93.注射用重组人白介素-2Recombinant Human Interleukin-2 for Injection94.注射用重组人促红素（CHO细胞）Recombinant Human Erythropoietin for Injection （CHO Cell）95.注射用重组人干扰素α1bRecombinant Human Interferon α1b for Injection96.注射用重组人干扰素α2aRecombinant H uman Interferon α2a for Injection97.注射用重组人干扰素α2a（酵母）Recombinant Human Interferon α2a for Injection （Yeast）98.注射用重组人干扰素α2bRecombinant Human Interferon α2b for Injection99.注射用重组人干扰素α2b（假单胞菌）Recombinant Human ter feron α2b for Injection （P.putida）注射用重组人干扰素α2b （酵母）Recombinant Human Interferon α2b for Injection （Yeast）100.注射用重组人干扰素γRecombinant Human Interferon γ for Injection101.注射用重组人粒细胞巨噬细胞刺激因子Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor for Injection102.生物制品包装规程103.生物制品分批规程104.生物制品分装和冻干规程105.生物制品国家标准物质制备和标定规程106.生物制品生产和检定用动物细胞基质制备及检定规程107.生物制品生产检定用菌毒种管理规程108.免疫血清生产用马匹检疫和免疫规程109.生物制品质量控制分析方法验证技术审评一般原则110.生物制品贮藏和运输规程111.疫苗流通和预防接种管理条例112.疫苗储存和运输管理规范号113.治疗用生物制品非临床安全性技术审评一般原则114.中国生物制品主要原辅材料质控标准中国地方标准1.DB37/T 1210-2009 猪繁殖与呼吸综合征油乳剂灭活疫苗（SD1株）免疫技术规范2.DB43/T 371-2007 鱼类嗜水气单胞菌灭活疫苗制作规程3.DB 21/T 1764-2009 兽用疫苗冷链建设技术与管理规范4.DB 45/T 588-2009 水产养殖鱼类细菌病组织浆疫苗制备与应用规范5.DB 23/T 888-2005 兽用疫苗贮存、运输和使用规范6.DB 35/T 989-2010 猪瘟活疫苗原料兔WHO标准1.TRS(Technical ReportSeries) No. 745Requirements for dried bcg vaccine, Annex 2冻干卡介苗质量要求，附录22.TRS No. 771 Requirements for dried BCG vaccine, Annex 12 冻干卡介苗质量要求，附录123.TRS No. 924 Guidelines for the production and control of inactivated oral cholera vaccine, Annex 3灭活口服霍乱疫苗的生产和质量控制指南，附录34.TRS No. 932 Guidelines for the production and quality control of candidate tetravalent dengue virus vaccines (live), Annex 1 备选四价登革病毒疫苗的生产和质量控制指南，附录15.TRS No. 927 Recommendations for DTP and combined vaccines, Amendments 2003, Annex 5百白破和联合疫苗建议，2003年修正版，附录56.TRS No. 800 Requirements for DTP, Annex 2 百白破疫苗质量要求，附录27.TRS No. 941 Guidelines for assuring the quality and non-clinical safety evaluation of DNA vaccines, Annex 1DNA疫苗的非临床安全评价和质量确认指南，附录18.TRS No. 848 Requirements for haemorrhagic fever with rental syndrome (HFRS) vaccine (inactivated), Annex 2肾综合症出血热疫苗（灭活）的质量要求，附录29.TRS No. 897 Recommendations for the production and control of Haemophilus influenzae type b conjugate vaccines, Annex 1 B型流感嗜血杆菌结合疫苗的生产和控制建议，附录110.TRS No. 858 Requirements for hepatitis A vaccines (inactivated), Annex 2 甲型肝炎疫苗（灭活）质量要求，附录211.TRS No. 771 Requirements for heptatitis B vaccine prepared from plasma , Annex 8由血浆制备的乙型肝炎疫苗的质量要求，附录812.TRS No. 786 Recommendations to assure the quality, safety and efficacy号TRS No. 889 of recombinant hepatitis B vaccines. proposed replacementof:L TRS 786, Annex 2 and TRS 889, Annex 4重组乙肝疫苗的质量、安全和效力确认建议（建议由TRS786附录2和TRS 889附录4代替）13.WHO/BS/06.2050 Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines重组人乳头瘤病毒病毒样颗粒疫苗的质量、安全和效力确认指南14.TRS No. 927 Recommendations for the production and control of influenza vaccine (inactivated), Annex 3灭活流感疫苗的生产和控制建议，附录315.WHO/IMD/PUB/04.1 WHO recommendations to assure the quality, safety and efficacy of influenza vaccines (human, live attenuated) for intranasal administrationWHO对鼻腔给药人类减活流感疫苗的质量、安全和效力确认的建议16.TRS No. 941 WHO biosafety risk assessment and guidelines for the production and quality control of human influenza pandemic vaccines, Annex 5WHO对人类流感疫苗的生产和质量控制的指南和生物安全风险评价，附录517.TRS No. 941 H1N1 specific-update of TRS 941, Annex 5对与H1N1的TRS 941的细节更行，附录518.WHO/BS/07.2074 Proposed guidelines: regulatory preparedness for human pandemic influenza vaccines人类流感疫苗的监管准备的建议指南19.WHO/BS/07.20644 Proposed revision recommendations for Japanese encephalitis vaccine (inactivated) for human use人用灭活乙型脑炎疫苗的修正建议20.TRS No. 910 Guidelines for the production and control of Japanese encephalitis vaccine (live) for human use , Annex 3人用活乙型脑炎疫苗的生产和控制指南，附录321.TRS No. 840 Requirements for measles, mumps and rubella vaccines and combined vaccine (live), Annex 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322.WHO/BS/06.2041 Recommendations to assure the quality, safety and efficacy of group a meningococcal conjugate vaccinesA群脑膜炎球菌结合疫苗的质量、安全和效力确认建议23.TRS No. 924 Recommendations for the production and control of Meningococcal group C conjugate vaccines, Annex 2号C群脑膜炎球菌结合疫苗的生产和控制建议，附录224.TRS No. 926Recommendations for the production and control of group C meningococcal conjugate vaccines, Addendum 2003, Annex 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225.WHO/BS/07.2065 Clinical evaluation of group C meningococcal conjugate vaccinesC群脑膜炎球菌结合疫苗的临床安全评价26.TRS No. 904 Requirements for meningococcal polysaccharide vaccine (Amendment 1999), Annex 2脑膜炎球菌多糖疫苗质量要求（1999年修正），附录227.TRS No. 658 Requirements for meningococcal polysaccharide vaccine, Addendum 1980, Annex 6脑膜炎球菌多糖疫苗质量要求（1999年修正），1980附件附录228.TRS No. 594 Requirements for meningococcal polysaccharide vaccine: Adopted 1975, Annex 2脑膜炎球菌多糖疫苗质量要求，1975年被采用，附录229.TRS No. 848 NOTE: requirements for measles, mumps and rubella vaccines and combined vaccine (live)(requirements for biological substances NO.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）30.TRS No. 941 Recommendations for whole cell pertussis vaccine, Annex 6 全细胞百日咳疫苗建议，附录631.TRS No. 800 Requirements for diphtheria, tetanus, pertussis and combined Vaccines, Annex 2百白破联合疫苗质量要求，附录232.TRS No. 927 Recommendations for diphtheria, tetanus, pertussis and combined Vaccines, Amendment 2003, Annex 5百白破联合疫苗建议，2003年修正，附录533.TRS No. 878 Guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines, Annex 2无细胞百日咳单价或联合疫苗的生产和控制指南，附录234.TRS No. 927 Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines-proposed replacement of TRS 927, Annex 2肺炎球菌结合疫苗的质量、安全和效力确认建议（由TRS 927代替），附录235.TRS No. 926 Guidelines for the safe production and quality control of号inactivated poliomyelitis vaccine manufacturered from wildpolioviruses (Addendum 2003 to recommendations for theproduction and quality control of poliomyelitis vaccine(Inactivated)), Annex 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236.TRS No. 910 Recommendations for the production and control of poliomyelitis vaccine (Inactivated), Annex 2灭活脊髓灰质炎疫苗的生产和控制建议，附录237.TRS No. 910 Recommendations for the production and control of poliomyelitis vaccine (oral) (Addendum 2000), Annex 1口服脊髓灰质炎疫苗的生产和控制建议（2000年附件），附录238.TRS No. 904 Recommendations for the production and control of poliomyelitis vaccine, oral; Revised 1999, Annex 1口服脊髓灰质炎疫苗的生产和控制建议，1999年修正，附录139.TRS No. 941 Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs, Annex 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240.TRS No. 658 Requirements for rabies vaccine for human use, Revised 1980, Annex 2人用狂犬病疫苗质量要求，1980年修正，附录241.TRS No. 673 Requirements for rift valley fever vaccines; Adopted 1981, Annex 4裂谷热疫苗的质量要求，1981年采用，附录442.TRS No. 941 Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral), Annex 3口服减活轮状病毒疫苗的质量、安全和效力确认指南，附录343.TRS No. 840 Requirements for measles, mumps and rubella vaccines and combined vaccines, live, Annex 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344.TRS No. 926 Recommendations for the production and quality control of smallpox vaccines, Annex 1天花疫苗的生产和质量控制建议，附录145.TRS No. 889 Guidelines for the production and quality control of synthetic peptide vaccines; Adopted 1997, Annex 1号合成肽疫苗的生产和质量控制指南，1997年采用，附录146.TRS No. 880 Requirements for diphteria, tetanus, pertussis and combined vaccines, Annex 2百白破联合疫苗的质量要求，附录247.TRS No. 927 Recommendations for diphtheria, tetanus, pertussis and combined vaccines, Amendments 2003, Annex 5百白破联合疫苗建议，2003年修正，附录548.TRS No. 889 Requirements for tick-borne encephalitis vaccine (inactivated), Adopted 1997, Annex 2灭活森林脑炎病毒疫苗的质量要求，1997年采用，附录249.TRS No. 840 Requirements for vi polysaccharide typhoid vaccine; Adopted 1992, Annex 1伤寒Vi多糖疫苗的质量要求，1992年采用，附录150.TRS No. 361 Requirements for typhoid vaccine; Adopted 1966, Annex 4 伤寒疫苗质量要求，1996年采用，附录451.TRS No. 700 Requirements for typhoid vaccine (Live, attenuated, Ty 21a, oral), Annex 3伤寒疫苗质量要求（口服减毒活Ty 21a株），附录352.TRS No. 848 Requirements for varicella vaccine (Live); Revised 1993, Annex 1活水痘疫苗质量要求，1993年修正，附录153.TRS No. 872 Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines.黄热病减毒活疫苗的质量、安全和效力确认建议。