Annex 3附录.docVIP

Annex 3 附录三 Procedure for prequalification of pharmaceutical Products 药品预认证程序 1. Introduction 介绍 2. Glossary 术语 3. Purpose and principles 目的及原则 4. Steps of the procedure 预认证步骤 5. Invitation for expressions of interest 意向书邀请 6. Data and information to be submitted 提交日期和信息 7. Screening of dossiers submitted 所申报品种技术资料的筛选 8. Dossier assessment 所申报品种技术资料评估 9. Site inspection 现场检查 10. Reporting and communication of results of the evaluation 评估结果报告及讨论 11. Outcome of the prequalification procedure 预认证结果 12. Maintenance of prequalification status 预认证状态的维护 13. Cost recovery 成本回收 14. Confidentiality undertaking 必威体育官网网址措施 15. Conflict of interest 利益冲突 References 参考资料 Appendix 1 附录1 Flowchart of WHO prequalification of pharmaceutical products WHO药品预认证流程图 Appendix 2 附录2 Characteristics of the prequalified pharmaceutical product to be made available for public access on the WHO web site WHO官网上公布的预认证药品的特性 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. 世界卫生组织给联合国相关药品采购机构提供了可供其采购的质量合格的备选药品。 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的此项举措的目的在于使获得符合WHO推荐标准和规范的质量合格的必需药品更加容易。基于药品生产企业递交的