WHO药品预认证项目及其参比制剂介绍

Introduction of the WHO prequalification of medicines programme and comparator product

本文阐述了WHO药品预认证项目的发展历程及认证药品范围,从递交项目意向书、项目意向书受理、文件评估和现场检查、形成预认证决议和列入预认证产品目录5方面详细介绍了认证程序,并初步统计和分析了我国药品生产企业参与认证的情况。同时,详细说明了WHO药品预认证项目中参比制剂的定义、发展历程和参比制剂的认定及获取方式,对我国药品参与WHO药品预认证项目走向国际市场提供了建议,具有重要的影响和指导意义。

The development history and concerned pharmaceutical product filed scope of the ＂ WHO prequalifieation of medicines programme＂, are described in this paper, as well as detailed elaboration of the prequalification procedure in five steps： submission of the expressions of interest, screening and acceptance of the expressions of interest, assessment of dossiers and site inspection, final decision on prequalification, and listing of prequalified product. The statistics and analysis of the status of domestic pharmaceutical manufacturing enterprises who have already been prequalified in the prequalification of medicines programme are also provided. At the same time, the definition and development history of the comparator product used in the prequalification programme is also introduced as well as the source and purchase of the comparator product. And the introduction to the system of ＂WHO prequalification of medicines programme＂ and its comparator product, has a vital influence and guiding significance to promote the domestic pharmaceutical products to the international market.