摘要
检索WHO药品预认证项目技术指南,翻译并整理原料药预认证项目的工作程序。结论:只有深入学习国际组织相关法规和技术要求、建立符合国际标准的监管体系,才能有效推进我国制药产品早日进入国际市场。
Search the WHO website for guidanc e and technical documents for Prequalification of Active Pharmaceutical Ingredients,and translate and compile the program.Conclusion：Learn the relevant regulations of international organization and requirements of technology in depth,to form the system of drug management which meets the international standards,only in this way can we enter the international market as soon as possible.
关键词
WHO
原料药
预认证
WHO
Active Pharmaceutical Ingredients
Prequalification
