中国化学仿制药企业通过who预认证可行性研究以注射用头孢曲松为例.doc

摘 要 是唯一的全球性药品质量保证规划药物清单现已成为国际机构的药品采购指南，同时也为越来越多的国家采用。我国为大国，制药企业参与联合国等国际采购，WHO预是第一道门槛。 研究目的：本文希望通过研究， 研究方法： 研究结果：注射用头孢曲松处于UNICEF第40位优先采购清单，且目前只有4家通过WHO PQ，非洲等地区也逐步上量，其市场前景良好。中国医药“十二五”加快国际认证， 关键词：WHO PQ；注射用头孢曲松；可行性；国际采购 The Feasibility Study of WHOＰrequalification for Chinese Chemical Generic Drug Manufacturers- Case study: Ceftriaxone for Injection Background: WHO PQ is WHO’s pre-qualification programme for medicines and medicine manufacturers, which is the only global pharmaceutical qualification program. It aims to provide safe, effective and quality essential medicines to the patients in developing countries, especially the medicines needed for the serious worldwide diseases like AIDS, tuberculosis and malaria. Now WHO PQ list has become the procurement guideline for international agencies, and also more and more countries refer to it for their procurement needs. China is a big pharmaceutical manufacturing nation, successful WHO PQ is the pre-requisite for Chinese pharmaceutical enterprises to participate in the UN and other international procurement for medicines. Because it doesn’t require a brand new drug to participate in the programme, many chemical generic drug manufacturers can enter the international market through WHO PQ. Purpose: Take Ceftriaxone for Injection as an example to help Chinese chemical generic drug manufacturers better understand WHO PQ requirements better, and be approved by WHO PQ, finally participate in international procurement. Methods: Take Ceftriaxone for Injection as an example to investigate its potential market, collected and analyzed WHO PQ related policy and regulations, compared the Chinese chemical generic registration GMP standards with the WHO PQ requirements, and summarized special requirements of WHO PQ. Studies in the above three aspects provided better understanding of WHO PQ feasibility and requirements, and could help Chinese enterprises to get a successful WHO PQ. Results: The study showed Ceftriaxone for