TRS961_Annex10 药物产品预认证程序.docVIP

WHO第961号技术报告 附件10 药品的预认证程序 2011 Procedure for prequalification of pharmaceutical products 1. Introduction介绍 2. Glossary术语 3. Purpose and principles目的和原则 4. Steps of the procedure程序步骤 5. Invitation for expressions of interest表达兴趣的 6. Data and information to be submitted要提交的数据和信息 7. Screening of dossiers submitted提交文件的筛选 8. Dossier assessment文件评估 9. Site inspection现场检查 10. Reporting and communication of the results of the evaluation评估结果的报告和沟通 11. Outcome of the prequalification procedure预认证程序的结果 12. Maintenance of prequalification status预认证状态的维护 13. Cost recovery成本回收 14. Confidentiality undertaking保密义务 15. Conflict of interest利益冲突 Appendix 1附件1 Flowchart of WHO prequalification of pharmaceutical products 药品WHO预认证流程图 Appendix 2附件2 Characteristics of the prequalified pharmaceutical product to be made available for public access on the WHO web site WHO官网上向公共开放的预认证药品信息  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 essential medicines that meet WHO-recommended norms and standards of acceptable quality. WHO undertakes a comprehensive evaluation of the quality of pharmaceutical products, based on information submitted by the manufacturers of such products or other applicants, and on an inspection of the corresponding manufacturing facilities and clinical sites. This is done through a standardized procedure which is based 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 m