© World Health Organization
WHO T echnical Report Series, No. 961, 2011
Annex 10 ：“Procedure for prequalification of pharmaceutical
Products”
2011年WHO系列技术报告, 961号文件,
附录10：“药品预认证流程”
目录
1.Introduction 介绍 (1)
2. Glossary 术语 (2)
3.Purpo and principles 目的和原则 (4)
4.Steps of the procedure 程序步骤 (6)
5. Invitation for expressions of interest 表达兴趣的邀请 (8)
6.Data and information to be submitted 要提交的数据和信息 (9)
7.Screening of dossiers submitted提交文件的筛选 (11)
8.Dossier asssment 文件评估 (12)
9.Site inspection 工厂检查 (13)
10.Reporting and communication of the results of the evaluation 评估结果的报告和通知
15
11.Outcome of the prequalification procedure 预认证程序的结果 (16)
12.Maintenance of prequalification status 预认证状态的维护 (18)
澳门丰泽13.Cost recovery 成本回收 (20)
14.Confidentiality undertaking 保密义务 (20)
15.Conflict of interest 利益冲突 (21)
Appendix 1 Flowchart of WHO prequalification of pharmaceutical products WHO附件1药品预认证流程图 (23)
Appendix 2 Characteristics of the prequalified pharmaceutical product to be made available for public access on the WHO web site . 附件2.WHO官网上向公共开放的预认证药品信息 (25)
1.Introduction 介绍
The World Health Organization (WHO) provides United Nations agencies with advice on the acceptability, in principle, of pharmaceutical products for procurement by such agencies.
世界卫生组织WHO向联合国机构提供根据该机构所采购药品是否可接受的建议。
This activity of WHO aims to facilitate access to priority esntial medicines that meet WHO-recommended norms and standards of acceptable quality. WHO undertakes a
comprehensive evaluation of the quality of pharmaceutical products, bad on information submitted by the manufacturers of such products or other applicants, and on an inspection of the correspondin
g manufacturing facilities and clinical sites. This is done through a standardized procedure which is bad on WHO-recommended quality standards. The quality of pharmaceutical products is obviously crucial for the safety and efficacy of such products.
WHO的本活动的目的使获得符合WHO推荐质量标准的优先基本药品的通道更方便。
WHO负责基于产品生产商或其它申请人提交的信息，基于对相关生产场所和临床试验场所进行的检查，对药品的质量进行综合评估。这些活动都是根据WHO推荐质量标准的标准程序来运作的。药品质量显然对于这类药品的安全性和有效性非常关键。
The pharmaceutical products found to meet the WHO-recommended quality standards are included in the list of medicines, as manufactured at the specified manufacturing sites, which are considered to be acceptable, in principle, for procurement by United Nations agencies.
The list of prequalified pharmaceutical products is principally intended for u by United Nations agencies —including the Joint United Nations Programme on HIV/AIDS (UNAIDS), United Nations Chil dren’s Fund (UNICEF) and United Nations Population Fund (UNFPA) —to guide their procurement decisions. The growing list of pharmaceutical products that have been found to meet WHO-recommended standards may, however, also be of interest to other organizations and countrie
上帝造物
窝沟封闭是什么意思s wishing to engage in the bulk procurement of pharmaceutical products.
所有被发现符合WHO推荐质量标准的药品均包括在药品清单中，包括其指定的生产场所，这些生产场所均被认为是可以接受的。这些清单中的药品供联合国机构采购选用。
通过预认证的产品的清单原则上来说是供联合国机构使用的---包括联合国爱滋病规划署（UNAIDS）、联合国儿童基金（UNICEF）和联合国人口基金（UNFPA）--指导其采购决策。逐渐增加的符合WHO推荐标准的药品清单可能也会对其它组织和国家有益，这些国家可能会希望参与批量采购药品。
草莓季节Inclusion in the list does not imply any approval by WHO of the pharmaceutical products and manufacturing sites in question (which is the sole prerogative of national authorities).
Moreover, inclusion in the list does not constitute an endorment or warranty by WHO of the fitness of any product for a particular purpo, including its safety and/or efficacy in the treatment of specific dias.
药品和生产场所包括在清单中并不意味着被WHO批准（那是国家药监机构专有的权利）。并且，包括在清单中并不表示WHO保证其所有产品对特殊目的的适用性，包括其在治疗特定疾病时的安全性和/或有效性。
2. Glossary 术语
The definitions given below apply to the terms ud in this procedure. They may have different meanings in other contexts.
以下给出的定义适用于本程序中所用的术语。在其它上下文中可能有不同含义。
（1）active pharmaceutical ingredient (API) 活性药物成分(原料药)
A substance ud in a finished pharmaceutical product (FPP), intended to furnish
pharmacological activity or to otherwi have direct effect in the diagnosis, cure, mitigation,
treatment or prevention of dia, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.
活性药物成分：用于制剂成品的一种物质，具有药物活性，或对诊断、治愈、缓解或预防疾病有直接影响，或对恢复、纠正或修复人类生理功能产生直接作用。
（2）Applicant申请人：
进攻犯规
The person or entity who, by the deadline mentioned in the invitation, submits an expression of interest (EOI) to participate in this procedure in respect of the product(s) listed in the invitation, together with the required documentation on such product(s).
在期限前，提交EOI表达想要参与产品预认证程序，并提交本程序所需的文件的人或实体。
（3）contract rearch organization (CRO) 合同研发组织（CRO）：
An organization (commercial, academic or other) to which an applicant may have transferred some of its tasks and obligations in relation to the conduct of clinical studies with the product submitted to WHO for asssment under the current procedure.
合同研发组织：接受申请人可能将要提交WHO作预认证的产品中，有些与临床研究有关的任务或义务外包的组织（商业、学术或其它）。迪玛希歌曲
（4）finished pharmaceutical product (FPP) 成品药：
A finished dosage form of a pharmaceutical product, which has undergone all stages of manufacture, including packaging in its final container and labelling.
药品成品：已完成所有生产步骤，包括最终包装和标签的制剂成品。
（5）invitation for expressions of interest (EOIs) or invitation 意向邀请书（邀请书）：Invitation calling upon interested parties (e.g. manufacturers or other applicants) to submit an expression of interest (EOI) to WHO by a specified deadline for the purpo of participating in the WHO prequalification procedure in respect of the product(s) listed in the invitation. Such an EOI should be accompanied by the required documentation on the product(s) in question.
意向邀请书：召集有兴趣组织（例如，生产商或其它申请人），根据WHO列在邀请中的产品，在指定的期限前向WHO提交表示其兴趣，以参与WHO预认证程序。该EOI 应与涉及产品所需的资料一起提交。
（6）Manufacturer 生产商：
中国之最A company that produces, packages, repackages, labels and/or relabels pharmaceutical products.
万圣节问候语生产商：一个从事药品生产、包装、再包装、贴标和/或再贴标的公司。
（7）pharmaceutical product 药品：
Any substance or combination of substances marketed or manufactured to be marketed for treating or preventing dia in human beings, or with a view to making a medical diagnosis in human bein
gs, or to restoring, correcting or modifying physiological functions in human beings.
药品：所有销售或生产准备销售的物质或物质混合物，用于治疗或防止人类疾病，或诊断人类疾病，或恢复、纠正或修复人类的生理功能。
（8）Prequalification 预认证：
Standardized quality asssment procedure of WHO to evaluate the acceptability, in principle, of pharmaceutical products for purcha by United Nations agencies. Agencies using information resulting from the prequalification procedure should perform additional steps of qualification prior to purchasing, such as ensuring financial stability and standing of the supplier, ability to supply the required quantities, curity of the supply chain, preshipment quality control and other related aspects.
预认证：WHO的标准质量评估程序，用于评价联合国机构所采购的药品的可接受性。
机构在使用这些通过预认证收集的信息前，要另外采取一些确认措施，例如确认经济稳定性、供应商的立场、供应所需数量的能力、供应链的安全性、发货前质量控制和其它相关方面。
（9）stringent regulatory authority (SRA)严格法规机构：
For the purpo of this procedure, a stringent regulatory authority (SRA) is:
— the medicines regulatory authority in a country which is: (a) a member of the International Conference on Harmonisation (ICH) (European Union (EU) Japan and the United States of America); or (b) an ICH Obrver, being the European Free Trade Association (EFTA) as reprented by SwissMedic and Health Canada (as may be updated from time to time); or (c)
a regulatory authority associated with an ICH member through a legally-binding, mutual
recognition agreement inc luding Australia, Iceland, Liechtenstein and Norway (as may be updated from time to time); and only in relation to good manufacturing practices (GMP) inspections: a medicine regulatory authority that is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as specified at www.picscheme.
本程序下，严格法规机构指：
—国家药品法规机构是：（a）是ICH成员之一（欧盟、日期和美国），或（b）ICH观察员，是欧洲自由贸易联盟EFTA由瑞士药监和加拿大药监代表（可能会随时更新），或（c）通过合法联系、共认协议与ICH成员协作的药监局，包括澳大利亚、冰岛、里兹本、挪威（可能会随时更新），以及仅与GMP检查相关：药品法规当局是PIC/S 组织的成员之一
3.Purpo and principles 目的和原则
The purpo of this WHO procedure is to evaluate whether certain pharmaceutical products (considered by WHO to be vital for the prevention and treatment of human immunodefic iency virus/acquired immunodefic iency syndrome (HIV/AIDS), tuberculosis, malaria and other dias, or for reproductive health) meet the requirements recommended by WHO and are manufactured in compliance with current good manufacturing practices (hereinafter referred to as GMP).
本WHO程序的目的是评估特定的药品（WHO认为治疗艾滋病、肺结核、疟疾和其它疾病，或生殖健康必须的药物）是否符合由WHO推荐的要求，是否在符合GMP的条
件下生产。
This procedure established by WHO is bad on the following principles:
本程序由WHO建立，基于以下原则
—the medicines eligible for prequalification are listed in invitations for EOI published on the WHO web site (who.int/prequal/info_applicants/info_for_applicants_EOIs.htm);
—适合预认证的药品在WHO官网上公布的EOI邀请中列出
— a general understanding of the production and quality control activities of the manufacturer;
—对生产商的生产和质量控制活动的共同了解
— asssment of pharmaceutical product data and information on safety, efficacy and quality submitted by the manufacturer, including product formulation, manufacture and test data and results;
—对生产商提交的药品安全、有效性和质量的数据和信息进行评估，包括产品配方、生产和检测数据和结果
— inspection of finished pharmaceutical product (FPP) and active pharmaceutical ingredient (API) manufacturing site(s) for compliance with GMP;
—对原料药和制剂生产场所GMP符合性的检查
— inspection of clinical testing units or contract rearch organizations (CROs) performing clinical trials for compliance with current good clinical practices (hereinafter referred to as GCP) and current good laboratory practices (hereinafter referred to as GLP);
—对实施临床研究的临床试验单位或合同研究机构（CROs）进行GCP和GLP符合性检查
— reliance on the information supplied by stringent national medicines regulatory authorities;—依赖由严格国家药监机构提供的信息
— random sampling and testing of pharmaceutical products supplied;
—对供货的药品进行随机抽样和检测
— handling of complaints and recalls reported to WHO; and
—处理报告至WHO的客诉和召回，以及
— monitoring of complaints from agencies and countries.
—药监机构和国家对客诉的监控
WHO may collaborate with national medicines regulatory authorities (NMRAs) regarding dossier asssments and inspections. Subject to the terms of ction 4 below, the
