WHO的技术报告和附件汇总

huhuhaha

前几天无聊，将WHO的一些技术报告跟附件汇总了一下，看看有没有用得着的

WHO_TRS_929  Annex1	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
WHO_TRS_929 Annex2	Good manufacturing practices:  requirement for the sampling of starting     materials (amendment)	药品生产质量管理规范：起始物料抽样要求(修订)
WHO_TRS_929 Annex3	WHO Good Manufacturing  Practices: water for pharmaceutical use	药品生产质量管理规范：制药用水
WHO_TRS_929 Annex4	WHO guidelines for sampling of  pharmaceutical products and related     materials	关于药品和相关物料的抽样指导原则
WHO_TRS_929 Annex5	Guidelines for registration of  fixed-dose combination medicinal products	固定剂量复方制剂注册指导原则
WHO_TRS_937 Annex1	List 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目录
WHO_TRS_937 Annex2	Supplementary guidelines on good  manufacturing practices for heating, ventilation and air-conditioning systems  for non-sterile pharmaceutical dosage forms	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
WHO_TRS_937 Annex3	Supplementary guidelines on good  manufacturing practices for the manufacture of herbal medicines	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
WHO_TRS_937 Annex4	Supplementary guidelines on good  manufacturing practices: validation	《药品生产质量管理规范》的补充指导原则：验证
WHO_TRS_937 Annex5	Good distribution practices for  pharmaceutical products	《药品分销质量管理规范》
WHO_TRS_937 Annex6	A model quality assurance system  for procurement agencies(Recommendations for quality assurance systems  focusing on prequalifi cation of products and manufacturers, purchasing,  storage and distribution of pharmaceutical products)	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、储藏分销环节的质量保证体系的建议)
WHO_TRS_937 Annex7	Multisource (generic)  pharmaceutical products: guidelines on registration requirements to establish  interchangeability	多来源(仿制)药晶:建立可互换性注册要求的指导原则
WHO_TRS_937 Annex8	Proposal to waive in vivo  bioequivalence requirements for WHO Model List of Essential Medicines  immediate-release,solid oral dosage forms	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
WHO_TRS_937 Annex9	Additional guidance for  organizations performing in vivo bioequivalence studies	对实施体内生物等效性研究机构的补充指南
WHO_TRS_943 Annex1	The International Pharmacopoeia  – related substances tests:dosage form monographs guidance notes	《国际药典》有关物质检查：制剂指南说明
WHO_TRS_943 Annex2	List 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目录
WHO_TRS_943 Annex3	General guidelines for the  establishment, maintenance     and distribution of chemical reference substances. Revision	化学对照品建立、管理及销售的一般指导原则
WHO_TRS_943 Annex4	Procedure for assessing the  acceptability, in principle, of pharmaceutical products for purchase by  United Nations agencies	联合国机构对采购药品的质量评估一般程序
WHO_TRS_943 Annex5	Prequalifi cation of quality  control laboratories. Procedure for assessing the acceptability, in  principle, of quality control laboratories for use by United Nations agencies	联合国机构用质量控制室的评估程序
WHO_TRS_943 Annex6	Guidance on variations to a  prequalifi ed product dossier	预认证产品文件变更指南
WHO_TRS_948 Annex1	List 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目录
WHO_TRS_948 Annex2	Procedure for assessing the  acceptability, in principle, of male latex condoms for purchase by United  Nations agencies	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
WHO_TRS_948 Annex3	Procedure for assessing the  acceptability, in principle, of TCu380A intrauterine devices for purchase by  United Nations agencies	联合国机构对采购的TCu380A 宫内节育器质量评估的一般程序
WHO_TRS_948 Annex4	Guidelines on active  pharmaceutical ingredient master fi le procedure	关于活性药物成分主控文档程序文件的指导原则
WHO_TRS_948 Annex5	International Nonproprietary  Names for biological and biotechnological substances: a review	生物和生物技术物质国际非专利名称(修订稿)
WHO_TRS_953 Annex1	List 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目录
WHO_TRS_953 Annex2	Stability testing of active  pharmaceutical ingredients and fi nished pharmaceutical products	药物活性成分和药物制剂成品的稳定性试验
WHO_TRS_953 Annex3	Procedure for prequalifi cation  of pharmaceutical products	药品预认证程序
WHO_TRS_953 Annex4	Procedure for assessing the  acceptability, in principle, of active pharmaceutical ingredients for use in  pharmaceutical products	对用于药品活性药物成分（API）质量评价的一般程序
WHO_TRS_957 Annex1	WHO good practices for  pharmaceutical quality control laboratories	世界卫生组织药品质量控制实验室质量管理规范
WHO_TRS_957 Annex2	W HO good manufacturing  practices for active pharmaceutical ingredients	ＷＨＯ活性药物成分生产质量管理规范
WHO_TRS_957 Annex3	WHO good manufacturing practices  for pharmaceutical products     containing hazardous substances	世界卫生组织关于含有害物质的药品生产质量管理规范
WHO_TRS_957 Annex4	WHO good manufacturing practices  for sterile pharmaceutical products	ＷＨＯ无菌制剂的药品生产质量管理规范
WHO_TRS_957 Annex5	WHO good distribution practices  for pharmaceutical products	ＷＨＯ药品分销质量管理规范
WHO_TRS_957 Annex6	Guidelines on the requalifi  cation of prequalifi ed dossiers	预认证文件的再认证指导原则
WHO_TRS_957 Annex7	Guidelines for the preparation  of a contract research organization master fi le	制定合同研究机构主文档的指导原则
WHO_TRS_961 Annex1	Release procedure of  International Chemical Reference Substances	国际化学对照品的审批程序
WHO_TRS_961 Annex2	WHO good practices for  pharmaceutical microbiology laboratories	ＷＨＯ 药品微生物实验室质量管理规范
WHO_TRS_961 Annex3	WHO good manufacturing  practices: main principles for pharmaceutical products	ＷＨＯ 药品生产质量管理规范: 主要原则
WHO_TRS_961 Annex4	WHO good manufacturing practices  for blood establishments (jointly with the Expert Committee on Biological  Standardization)	ＷＨＯ 血液机构生产质量管理规范的指导原则
WHO_TRS_961 Annex5	WHO guidelines on good  manufacturing practices for heating, ventilation and air-conditioning systems  for non-sterile pharmaceutical dosage forms	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
WHO_TRS_961 Annex6	WHO good manufacturing practices  for sterile pharmaceutical products	ＷＨＯ 无菌制剂的药品生产质量管理规范
WHO_TRS_961 Annex7	WHO guidelines on transfer of  technology in pharmaceutical manufacturing	ＷＨＯ 药品生产技术转移指南
WHO_TRS_961 Annex8	Good pharmacy practice:  standards for quality of pharmacy services (joint FIP/WHO)	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
WHO_TRS_961 Annex9	Model guidance for the storage  and transport of time- and temperature-sensitive pharmaceutical products  (jointly with the Expert Committee on Biological Standardization)	时间敏感和温度敏感药品储存运输指导规范
WHO_TRS_961 Annex10	Procedure for prequalifi cation  of pharmaceutical products	药品预认证程序
WHO_TRS_961 Annex11	Guidelines on submission of  documentation for prequalifi cation of innovator finished pharmaceutical  products approved by stringent regulatory authorities	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
WHO_TRS_961 Annex12	Prequalifi cation of quality  control laboratories. Procedure for assessing the acceptability, in  principle, of quality control laboratories for use by United Nations agencies	质量控制实验室预认证
WHO_TRS_961 Annex13	WHO guidelines for preparing a  laboratory information file	ＷＨＯ 关于编写实验室信息文件的指导原则
WHO_TRS_961 Annex14	WHO guidelines for drafting a  site master fi le	ＷＨＯ 关于起草生产场地主文件的指导原则
WHO_TRS_961 Annex15	Guidelines on submission of  documentation for a multisource (generic) finished product: general format:  preparation of product dossiers in common technical document format	提交多来源(仿制) 制剂成品文件的指导原则
WHO_TRS_970 Annex1	Development of monographs for  The International Pharmacopoeia	«国际药典» 质量标准的建立
WHO_TRS_970 Annex2	WHO good manufacturing  practices: water for pharmaceutical use	ＷＨＯ 药品生产质量管理规范:制药用水
WHO_TRS_970 Annex3	Pharmaceutical development of  multisource (generic) pharmaceutical products - point to consider	多来源药物制剂成品(仿制) 研发———要点
WHO_TRS_970 Annex4	Guidelines on submission of  documentation for a multisource (generic) finished pharmaceutical product for  the WHO Prequalification of Medicines Programme:quality part	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
WHO_TRS_970 Annex5	Development of paediatric  medicines: points to consider in formulation	儿科药物的研发: 制剂处方要点
WHO_TRS_970 Annex6	Recommendations for quality  requirements for artemisinin as a starting material in the     production of antimalarial active pharmaceutical ingredients	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_981 Annex1	Release procedure for  International Chemical Reference Substances
WHO_TRS_981 Annex2	WHO guidelines on quality risk  management
WHO_TRS_981 Annex3	WHO guidelines on variations to  a prequalified product
WHO_TRS_981 Annex4	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_TRS_986 Annex1	The International Pharmacopoeia  – Updating mechanism for the section on radiopharmaceuticals
WHO_TRS_986 Annex2	WHO good manufacturing practices  for pharmaceutical products: main principles
WHO_TRS_986 Annex3	Model quality assurance system  for procurement agencies
WHO_TRS_986 Annex4	Assessment tool based on the  model quality assurance system for procurement     agencies: aide‑memoire for inspection
WHO_TRS_986 Annex5	Guidelines on submission of  documentation for prequalification of finished     pharmaceutical products approved by stringent regulatory authorities
WHO_TRS_986 Annex6	Guidelines on submission of  documentation for a multisource (generic) finished     pharmaceutical product: quality part
WHO_TRS_992 Annex1	Procedure for the development of  monographs and other texts for The International     Pharmacopoeia
WHO_TRS_992 Annex2	Updating mechanism for the  section on radiopharmaceuticals in The International     Pharmacopoeia
WHO_TRS_992 Annex3	Guidelines on good manufacturing  practices: validation, Appendix 7: non‑sterile     process validation
WHO_TRS_992 Annex4	General guidance on hold-time  studies
WHO_TRS_992 Annex5	Technical supplements to Model  guidance for the storage and transport of time- and     temperature-sensitive pharmaceutical products
WHO_TRS_992 Annex6	Recommendations for quality  requirements when plant‑derived artemisinin is used as     a starting material in the production of antimalarial active pharmaceutical  ingredients
WHO_TRS_992 Annex7	Multisource (generic)  pharmaceutical products: guidelines on registration     requirements to establish interchangeability
WHO_TRS_992 Annex8	Guidance on the selection of  comparator pharmaceutical products for equivalence     assessment of interchangeable multisource (generic) products
WHO_TRS_992 Annex9	Good review practices:  guidelines for national and regional regulatory authorities
WHO_TRS_996 Annex1	Good pharmacopoeial practices
WHO_TRS_996 Annex2	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
WHO_TRS_996 Annex3	WHO good manufacturing practices  for biological products
WHO_TRS_996 Annex4	Guidance on good manufacturing  practices: inspection report
WHO_TRS_996 Annex5	Guidance on good data and record  management practices
WHO_TRS_996 Annex6	Good trade and distribution  practices for pharmaceutical starting materials
WHO_TRS_996 Annex7	Guidelines on the conduct of  surveys of the quality of medicines
WHO_TRS_996 Annex8	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_TRS_996 Annex9	Guidance for organizations  performing in vivo bioequivalence studies
WHO_TRS_996 Annex10	WHO general guidance on  variations to multisource pharmaceutical products
WHO_TRS_1003 Annex1	WHO guidelines for selecting  marker substances of herbal origin for quality control     of herbal medicines
WHO_TRS_1003 Annex2	The International Pharmacopoeia:  revised concepts and future perspectives
WHO_TRS_1003 Annex3	Prequalification of quality  control laboratories: procedure for assessing the acceptability,     in principle, of quality control laboratories for use by United Nations  agencies
WHO_TRS_1003 Annex4	WHO Global Model Regulatory  Framework for Medical Devices including in vitro     diagnostic medical devices
WHO_TRS_1003 Annex5	General background notes on the  list of international comparator pharmaceutical     products
WHO_TRS_1003 Annex6	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)
WHO_TRS_1010 Annex1	WHO guidelines on good herbal  processing practices for herbal medicines
WHO_TRS_1010 Annex2	Guidelines on good manufacturing  practices for the manufacture of herbal medicines
WHO_TRS_1010 Annex3	Considerations for requesting  analysis of medicines samples
WHO_TRS_1010 Annex4	Model certificate of analysis
WHO_TRS_1010 Annex5	WHO guidance on testing of  “suspect” falsified medicines
WHO_TRS_1010 Annex6	Good pharmacopoeial practices:  Chapter on monographs for compounded preparations
WHO_TRS_1010 Annex7	Good pharmacopoeial practices:  Chapter on monographs on herbal medicines
WHO_TRS_1010 Annex8	Guidelines on heating,  ventilation and air-conditioning systems for non-sterile     pharmaceutical products
WHO_TRS_1010 Annex9	Guidance on good practices for  desk assessment of compliance with good     manufacturing practices, good laboratory practices and good clinical  practices for     medical products regulatory decisions
WHO_TRS_1010 Annex10	Stability testing of active  pharmaceutical ingredients and finished pharmaceutical     products
WHO_TRS_1010 Annex11	Collaborative procedure in the  assessment and accelerated national registration of     pharmaceutical products and vaccines approved by stringent regulatory  authorities
WHO_TRS_1019 Annex1	Procedure for the development of  World Health Organization medicines quality     assurance guidelines
WHO_TRS_1019 Annex2	Guidelines on heating,  ventilation and air-conditioning systems for non-sterile     pharmaceutical products
	Part 2: Interpretation of  Guidelines on heating, ventilation and air-conditioning systems     for non-sterile pharmaceutical products
WHO_TRS_1019 Annex3	Good manufacturing practices:  guidelines on validation
	Appendix 1 Validation of  heating, ventilation and air-conditioning systems
	Appendix 2 Validation of water  systems for pharmaceutical use 136
	Appendix 3 Cleaning  validation
	Appendix 4 Analytical procedure  validation
	Appendix 5 Validation of  computerized systems
	Appendix 6 Guidelines on  qualification
	Appendix 7 Non sterile process  validation
WHO_TRS_1019 Annex4	Protocol to conduct equilibrium  solubility experiments for the purpose of Biopharmaceutics Classification  System-based classification of active pharmaceutical     ingredients for biowaiver
WHO_TRS_1019 Annex5	Guidelines on import procedures  for medical products
WHO_TRS_1019 Annex6	Good practices of national  regulatory authorities in implementing the collaborative     registration procedures for medical products
	Appendix 1 An example of  information to applicants for registration via the     WHO collaborative registration procedure
	Appendix 2 Verification for  product submitted under the WHO     collaborative procedure
	Appendix 3 Abridged/abbreviated  review for product submitted under the     WHO collaborative procedure
	Appendix 4 Additional  information to be included in the screening checklist
	Appendix 5 Example of a national  regulatory authority reliance model     approach: information, documentary evidence and assessment activity
	Appendix 6 Model acknowledgement  or approval letter for variations of     products registered through the WHO collaborative procedure

huhuhaha

huhuhaha 发表于 2019-7-24 08:18
在Medicines and health products的栏目下，有个Publications

WHO Technical report series 那里面就是

huhuhaha

kuanghua007 发表于 2019-7-24 08:11
谢谢楼主！之前在WHO官网没有找到，请问WHO官网哪个位置有这些资料？谢谢

在Medicines and health products的栏目下，有个Publications

椒陵小小兵

谢谢

蓝若遥

谢谢，但一直好奇 WHO,ICH,EU GMP是什么关系，楼主知道吗？

wuzi123456

好东西，谢谢分享

kuanghua007

谢谢楼主！之前在WHO官网没有找到，请问WHO官网哪个位置有这些资料？谢谢

huhuhaha

蓝若遥 发表于 2019-7-23 21:03
谢谢，但一直好奇 WHO,ICH,EU GMP是什么关系，楼主知道吗？

WHO是世界卫生组织，他们没有明显的地域，但是有很多他们管辖下的工厂；ICH是欧美还有日本定义的一个发达国家的协调原则，后来参与的人越来越多；EU就是欧盟的法规；GMP是药品生产质量管理规范，哥哥国家基本都有这样一个法规，这几年总体都比较一致了

jimmiechen

谢谢分享，谢谢分享！！

masiying

谢谢楼主的分享！学习一下！

锐哥

强大的楼主.赞赞赞.

GAUDY

谢谢楼主，这个东西太好了！就是弱弱的问一句，为什么这个技术报告每年都有，WHO这样做的目的是什么？

huhuhaha

GAUDY 发表于 2019-7-24 09:34
谢谢楼主，这个东西太好了！就是弱弱的问一句，为什么这个技术报告每年都有，WHO这样做的目的是什么？

我觉得应该就跟我们回顾一样吧，每年都会把之前的工作不到位的地方补充完善，做的更好点

董航涛

感谢分享，学习一下

加菲1981

谢谢整理分享，学习一下，受益匪浅！

zbfan

总结的全面

预知子

虽然官网可下，但还是感谢汇总

镇世恶xz

特别硬的干货

镇世恶xz

谢谢楼主  真心感谢

千古流芳芳

不得不佩服楼主的强大。。。非常感谢，先收藏   哈哈哈