世界卫生组织药品资格预审数据分析

Data Analysis of Current WHO Medicine and Vaccine Prequalification

对世界卫生组织(WHO)医疗产品资格预审进行简要介绍,并从品种信息与数量、国家或地区分布、国内获批产品及其企业等方面,对当前获批列入WHO资格预审清单中的原料药、化学制剂和疫苗相关数据进行分析与研究,以期为我国制药行业掌握WHO资格预审药品最新市场形势提供借鉴与数据支持,为相关监管机构掌握我国企业参与WHO资格预审情况提供参考。

Based on a brief introduction of World Health Organization(WHO)Prequalification of Medical Products, the study focused on the analysis and research of current data related to APIs, chemical finish products and vaccines approved in Prequalification list. Statistical analysis and discussion were performed from the aspects of product information and quantity, national or regional distribution, approved products and manufacturers in domestic,-etc. It was expected to provide reference and statistical data support about current international drug market related to WHO PQ for pharmaceutical industry, and provided reference for relevant regulatory agencies to understand current situation of domestic manufacturers participated in the WHO prequalification.