• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2023, Vol. 40 ›› Issue (1): 97-100.

• 管理研究 • 上一篇    

世界卫生组织药品资格预审数据分析

  颜若曦   

  1. 国家药品监督管理局食品药品审核查验中心, 北京 100044
  • 收稿日期:2022-11-28 修回日期:2023-01-28 出版日期:2023-02-28 发布日期:2023-02-28

Data Analysis of Current WHO Medicine and Vaccine Prequalification

  1. Center for Food and Drug Inspection of NMPA, Beijing 100044, China
  • Received:2022-11-28 Revised:2023-01-28 Online:2023-02-28 Published:2023-02-28

摘要: 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。

关键词: font-size:medium, ">资格预审;化学药品;疫苗;世界卫生组织

Abstract: 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.

Key words: font-size:medium, ">Prequalification; Medicine;Vaccine;World Health Organization(WHO)

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