摘要
目的为中国原料药进入国际市场找出一条合适的途径。方法查阅近年来相关文献,对WHO原料药预认证程序进行分析,阐述WHO原料药预认证的重要性。结果与结论深入学习国际组织相关法规,严格按照WHO GMP规范指导生产,接受WHO文档评估和现场检查,是中国原料药参与WHO国际采购、进入国际市场的最佳途径。
Objective To investigate appropriate ways for Chinese active pharmaceutical ingredients （APIs） to enter the international market. Methods The WHO prequalification procedure of APIs was analyzed by reviewing papers published in recent years, and the importance of WHO prequalification procedure of APIs was elaborated. Results and Conclusion To further study the relevant regulations of international organizations, instruct production strictly according to WHO GMP, and accept WHO dossier evaluation and on-site inspection as the best ways for Chinese APIs to participate in WHO international procurement and enter WHO international market.
出处
《中国药事》
CAS
2013年第5期481-484,共4页
Chinese Pharmaceutical Affairs
关键词
WHO
原料药
预认证
WHO
active pharmaceutical ingredients （APIs）
prequalification
