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WHO TRS官方公布的版本为51-21。
目前WHO官方翻译的版本为46-39。
下面是WHO TRS附录列表，按时间由近及远的顺序排序。
本段为所有附录的标题翻译（无删减）。
如有不当之处，望交流指正。
WHO TRS 1003 Fifty-first report 报告51
Annex 1附录1
WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines
针对药草药品质量控制的草药源头标记物质选择的WHO指南
Annex 2附录2
The International Pharmacopoeia: revised concepts and future perspectives
国际药典：修订标准和未来展望
Annex 3附录3
Prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
QC实验室资格预审：评估适用性的规程，主要针对联合国机构使用的QC实验室
Annex 4附录4
WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices
针对药械包括体外诊断药械的WHO全球监管框架样本
Annex 5附录5
General background notes on the list of international comparator pharmaceutical products
国际参照药品列表上的通用背景注释
Annex 6附录6
Equilibrium solubility experiments for the purpose of classification of active
pharmaceutical ingredients according to the Biopharmaceutics Classification System, as an appendix to the WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 7, WHO Technical Report Series, No. 992, 2015)
为分类活性药品成分进行溶解平衡试验，根据生物制药分类系统，作为WHO指南多源头（仿制）药品的附件：建立可互换性的注册要求指南 (附录7 WHO TRS 992, 2015)
WHO TRS 996 Fiftieth report报告50
Annex 1 附录1
Good pharmacopoeial practices
GPhP
Annex 2 附录2
FIP-WHO technical guidelines: Points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products
FIP（国际药学联合会）-WHO 技术指南：医疗保健专业在无法获得的授权儿科药剂的法规方面的考虑
Annex 3 附录3
WHO good manufacturing practices for biological products
WHO 生物产品GMP
Annex 4 附录4
Guidance on good manufacturing practices: inspection report
GMP指南：检查报告
Annex 5 附录5
Guidance on good data and record management practices
针对良好数据和记录管理操作的指南
Annex 6 附录6
Good trade and distribution practices for pharmaceutical starting materials
制药起始物料的良好贸易和分销操作
Annex 7 附录7
Guidelines on the conduct of surveys of the quality of medicines
药品质量调查指南
Annex 8 附录8
Collaborative procedure between the World Health Organization (WHO) Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines
WHO资格预审团队和对通过WHO资格预审的药品和疫苗的国际注册的评估和促进的国际监管机构的合作规程
Annex 9 附录9
Guidance for organizations performing in vivo bioequivalence studies
针对在活体进行生物等效性研究的组织的指南
Annex 10附录10
WHO general guidance on variations to multisource pharmaceutical products
针对多源药品变化的WHO总指南
WHO TRS 992 Forty-ninth report 报告49
Annex 1 附录1
Procedure for the development of monographs and other texts for The International Pharmacopoeia
国际药典专题著作及其它文本改良的规程
Annex 2 附录2
Updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia
国际药典中放射性药物部分的更新机制
Annex 3 附录3
Guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation
GMP指南：验证，附录7：未灭菌工艺的验证
Annex 4 附录4
General guidance on hold-time studies
关于保存时间研究的总指南
Annex 5 附录5
Technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products
易受时间和温度影响药品的贮存和运输的技术增补指南范本
Annex 6 附录6
Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients
当从植物中提取的青蒿素在抗疟药活性药物成分生产中被用作起始物料时，质量要求方面的建议。
Annex 7 附录7
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
多源（仿制）药品：针对建立互换性注册要求的指南
Annex 8 附录8
Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
用于可更换多来源（仿制）产品等效性评估的可比照药品选择指南
Annex 9 附录9
Good review practices: guidelines for national and regional regulatory authorities
良好回顾操作：国家和地区的监管指南
WHO TRS 986 Forty-eighth report 报告48
Annex 1 附录1
The International Pharmacopoeia - Updating mechanism for the section
on radiopharmaceuticals
国际药典——放射性药物部分的更新机制
Annex 2 附录2
WHO good manufacturing practices for pharmaceutical products: main principles
WHO药品GMP：主要原则
Annex 3 附录3
Model quality assurance system for procurement agencies
针对采购机构的QA系统范本
Annex 4 附录4
Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection
基于采购机构QA系统范本的评估工具：检查备忘录
Annex 5 附录5
Guidelines on submission of documentation for prequalification of finished
pharmaceutical products approved by stringent regulatory authorities
严格的监管机构，对药品成品批准资格预审文件提交的指南
Annex 6 附录6
Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part
多来源（仿制）药品成品提交文件指南：质量部分
WHO TRS 981 Forty-seventh report报告47
Annex 1附录1
Release procedure for International Chemical Reference Substances
国际化学对照品的放行规程
Annex 2附录2
WHO guidelines on quality risk management
质量风险管理的WHO指南
Annex 3附录3
WHO guidelines on variations to a prequalified product
WHO针对资格预审产品变化的指南
Annex 4附录4
Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO‑prequalified pharmaceutical products
WHO药品资格预审项目和国际药品监管机构在WHO药品资格预审的国际注册的评估和促进方面的合作规程
WHO TRS 970 Forty-sixth report报告46
Annex 1
Development of monographs for The International Pharmacopoeia
Annex 2
WHO good manufacturing practices: water for pharmaceutical use
Annex 3
Pharmaceutical development of multisource (generic) pharmaceutical
products - point to consider
Annex 4
Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part
Annex 5
Development of paediatric medicines: points to consider in formulation
Annex 6
Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients
附录１ «国际药典» 质量标准的建立
附录２ ＷＨＯ 药品生产质量管理规范:制药用水
附录３ 多来源药物制剂成品(仿制) 研发———要点
附录４ ＷＨＯ 药品预认证项目多来源(仿制) 制剂成品申报资料提交指南: 质量部分
附录５ 儿科药物的研发: 制剂处方要点
附录６ 青蒿素作为起始物料生产抗疟疾药活性成分时的推荐质量要求
WHO TRS 961 Forty-fifth report报告45
Annex 1
Release procedure of International Chemical Reference Substances
Annex 2
WHO good practices for pharmaceutical microbiology laboratories
Annex 3
WHO good manufacturing practices: main principles for pharmaceutical products
Annex 4
WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization)
Annex 5
WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
Annex 6
WHO good manufacturing practices for sterile pharmaceutical products
Annex 7
WHO guidelines on transfer of technology in pharmaceutical manufacturing
Annex 8
Good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO)
Annex 9
Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization)
Annex 10
Procedure for prequalifi cation of pharmaceutical products
Annex 11
Guidelines on submission of documentation for prequalifi cation of innovator finished pharmaceutical products approved by stringent regulatory authorities
Annex 12
Prequalifi cation of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
Annex 13
WHO guidelines for preparing a laboratory information file
Annex 14
WHO guidelines for drafting a site master file
Annex 15
Guidelines on submission of documentation for a multisource (generic) fi nished product: general format: preparation of product dossiers in common technical document format
附录１ 国际化学对照品的审批程序
附录２ ＷＨＯ 药品微生物实验室质量管理规范
附录３ ＷＨＯ 药品生产质量管理规范: 主要原则
附录４ ＷＨＯ 血液机构生产质量管理规范的指导原则
附录５ 非无菌药物制剂的加热、通风和空调系统的«药品生产质量管理规范» 补充指导原则
附录６ ＷＨＯ 无菌制剂的药品生产质量管理规范
附录７ ＷＨＯ 药品生产技术转移指南
附录８ ＦＩＰ / ＷＨＯ 关于«药房质量管理规范» 联合指导原则: 药房服务质量标准
附录９ 时间敏感和温度敏感药品储存运输指导规范
附录１０ 药品预认证程序
附录１１ 关于获得严格监管机构(ＳＲＡ) 批准的新药制剂产品 (ＦＰＰ) 提交预认证审批文件的指导原则
附录１２ 质量控制实验室预认证
附录１３ ＷＨＯ 关于编写实验室信息文件的指导原则
附录１４ ＷＨＯ 关于起草生产场地主文件的指导原则
附录１５ 提交多来源 (仿制) 制剂成品文件的指导原则
WHO TRS 957 Forty-fourth report报告44
Annex 1
WHO good practices for pharmaceutical quality control laboratories
Annex 2
W HO good manufacturing practices for active pharmaceutical ingredients
Annex 3
WHO good manufacturing practices for pharmaceutical products containing hazardous substances
Annex 4
WHO good manufacturing practices for sterile pharmaceutical products
Annex 5
WHO good distribution practices for pharmaceutical products
Annex 6
Guidelines on the requalifi cation of prequalifi ed dossiers
Annex 7
Guidelines for the preparation of a contract research organization master file
附录１ 世界卫生组织药品质量控制实验室质量管理规范
附录２ ＷＨＯ活性药物成分生产质量管理规范
附录３ 世界卫生组织关于含有害物质的药品生产质量管理规范
附录４ ＷＨＯ无菌制剂的药品生产质量管理规范
附录５ ＷＨＯ药品分销质量管理规范
附录６ 预认证文件的再认证指导原则
附录７ 制定合同研究机构主文档的指导原则
WHO TRS 953 Forty-third report报告43
Annex 1
List of available International Chemical Reference Substances and International Infrared Reference Spectra 75
Annex 2
Stability testing of active pharmaceutical ingredients and fi nished pharmaceutical products 87
Annex 3
Procedure for prequalifi cation of pharmaceutical products 131
Annex 4
Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products 149
附录1：国际化学对照品和国际红外对照光谱目录
附录2：药物活性成分和药物制剂成品的稳定性实验
附录3：药品预认证程序
附录4：对用于药品的活性药物成分（API）质量评价的一般程序
WHO TRS 948 Forty-second report报告42
Annex 1
List of available International Chemical Reference Substances and International Infrared Reference Spectra
Annex 2
Procedure for assessing the acceptability, in principle, of male latex condoms for purchase by United Nations agencies
Annex 3
Procedure for assessing the acceptability, in principle, of TCu380A intrauterine devices for purchase by United Nations agencies
Annex 4
Guidelines on active pharmaceutical ingredient master file procedure
Annex 5
International Nonproprietary Names for biological and biotechnological substances: a review
附录1：国际化学对照品和国际红外对照光谱目录
附录2：联合国机构对采购的男用乳胶安全套质量评估的一般程序
附录3：联合国机构对采购的TCu380A宫内节育器质量评估的一般程序
附件4：关于活性药物成分主控文档程序文件的指导原则
附件5：生物和生物技术物质国际非专利名称（修订稿）
WHO TRS 943 Forty-first report报告41
Annex 1
The International Pharmacopoeia–related substances tests: dosage form monographs guidance notes
Annex 2
List of available International Chemical Reference Substances and International Infrared Reference Spectra
Annex 3
General guidelines for the establishment, maintenance and distribution of chemical reference substances. Revision
Annex 4
Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Annex 5
Prequalifi cation of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
Annex 6
Guidance on variations to a prequalified product dossier
附录1：《国际药典》——有关物质检查：制剂指南说明
附录2：国际化学对照品和国际红外对照光谱目录
附录3：化学对照品建立、管理及销售的一般指导原则
附录4：联合国机构对采购药品的质量评估一般程序
附录5：联合国机构用质量控制实验室的评估程序
附录6：预认证产品文件变更指南
WHO TRS 937 Fortieth report报告40
Annex 1
List of available International Chemical Reference Substances and International Infrared Reference Spectra
Annex 2
Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
Annex 3
Supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines
Annex 4
Supplementary guidelines on good manufacturing practices: validation
Annex 5
Good distribution practices for pharmaceutical products
Annex 6
A model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products)
Annex 7
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Annex 8
Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
Annex 9
Additional guidance for organizations performing in vivobioequivalence studies
附录1：国际化学对照品和国际红外对对照光谱目录
附录2：非无菌药物制剂的供热、通风和空调系统的《药品生产质量管理规范》的补充指导原则
附录3：关于植物药生产的《药品生产质量管理规范》的补充指导原则
附录4：《药品生产质量管理规范》的补充指导原则：验证
附录5：《药品分销质量管理规范》
附录6：药品采购机构质量保证体系的范本（对药品及生产企业的预认证及药品采购、储藏和分销环节的质量保证体系的建议）
附录7：多来源（仿制）药品：建立可互换性注册要求的指导原则
附录8：关于豁免WHO基本药物目录中口服固体常释（普通）制剂体内生物等效性研究的要求
附录9：对实施体内生物等效性研究机构的补充指南
WHO TRS 929 report 39报告39
Annex 1
International Chemical Reference Substances and International Infrared Reference Spectra
Annex 2
Good manufacturing practices: requirement for the sampling of starting materials (amendment)
Annex 3
WHO Good Manufacturing Practices: water for pharmaceutical use
Annex 4
WHO guidelines for sampling of pharmaceutical products and related materials
Annex 5
Guidelines for registration of fixed-dose combination medicinal products
附录1 国际化学对照品和国际红外对照光谱
附录2 药品生产质量管理规范：起始物料抽样要求(修订)
附录3 WHO 药品生产质量管理规范：制药用水
附录4 WHO 关于药品和相关物料的抽样指导原则
附录5 固定剂量复方制剂注册指导原则
WHO TRS 917 report 38报告38
Annex 1附录1
Lists of available international chemical reference substances and international infrared reference spectra
国际化学对照品和国际红外对照光谱的可用列表
Annex 2附录2
Good trade and distribution practices for pharmaceutical starting materials
制药起始物料的良好贸易及分销实践
Annex 3附录3
WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
WHO制药起始物料证书计划的实施指南
Annex 4附录4
Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
主要针对联合国机构使用的QC实验室的适用性评估程序
Annex 5附录5
Guidelines for perparing a laboratory information file
实验室信息文档准备指南
Annex 6附录6
Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies
主要针对联合国机构使用的采购机构的适用性评估程序
Annex 7附录7
Guidelines for the preparation of a procurement agency information file
采购机构信息文档的准备指南
Annex 8附录8
Interim guidelines for the assessment of a procurement agency (based on the draft model quality assurance system for procurement agencies)
采购机构评估的临时指南（以针对采购机构的QA系统范本的草案为基础）
WHO TRS 908 report 37报告37
Annex 1附录1
Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
以药品为媒介传播的动物海绵体脑病风险建议
Annex 2附录2
The International Pharmacopoeia: revised concepts and future perspectives
国际药典：修订的概念和对未来的看法
Annex 3附录3
Guidelines on Good Manufacturing Practices for radiopharmaceutical products
放射性产品的GMP指南
Annex 4附录4
Good Manufacturing Practices for pharmaceutical products: main principles
药品GMP：主要准则
Annex 5附录5
Model certificate of Good Manufacturing Practices
GMP证书范本
Annex 6附录6
Guidance on Good Manufacturing Practices (GMP): inspection report
GMP指南：检查报告
Annex 7附录7
Application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals
HACCP(危害分析和临界控制点)方法在制药方面的应用
Annex 8附录8
Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
主要针对联合国机构购买药品的适用性评估程序
Annex 9附录9
Guide to good storage practices for pharmaceuticals
药品良好贮存实践指南
WHO TRS 902 report 36报告36
Annex 1附录1
List of available International Chemical Reference Substances
国际化学对照品的可用列表
Annex 2附录2
List of available International Infrared Reference Spectra
国际红外对照光谱的可用列表
Annex 3附录3
Good practices for national pharmaceutical control laboratories
国际制药控制实验室的良好操作（规范）
Annex 4附录4
Considerations for requesting analysis of drug samples
药品取样请验的注意事项
Annex 5附录5
Basic elements of good manufacturing practices in pharmaceutical production
药品生产GMP的基本要素
Annex 6附录6
Good manufacturing practices for sterile products
无菌产品GMP
Annex 7附录7
Guidelines on pre-approval inspections
预审批检查指南
Annex 8附录8
Quality systems requirements for national good manufacturing practice inspectorates
国际GMP检查团的质量系统要求
Annex 9附录9
Guidelines on packaging for pharmaceutical products
药品包装指南
Annex 10附录10
Model certificate of analysis
分析证书范本
Annex 11附录11
Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
针对可更换多来源（仿制）产品等效性评估的药品比照用仪器的选择指南
Annex 12附录12
Guidelines on the use of International Nonproprietary Names (INNs) for pharmaceutical substances
药物INNs（国际非专利名称）的使用指南 |
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发表于 2017-12-5 20:57:07
