Chinese Version of FDA Guidance for Pharmaceutical Insustry

In effort to support harmonization with international drug and device development, SFDA initiated Chinese translation project of U.S. FDA guidance, 系统地翻译和转化国外技术指导原则的工作美国FDA发布的指导原则（含草案）in 2009.

Current available Chinese version of FDA guidance:
原料及制备工艺相关指导原则 (9条)
制剂相关指导原则 (7条)
临床药理学相关指导原则 (15条)
临床研究进程中相关指导原则 (29条)
不同治疗领域指导原则 (81条)
审评质量管理规范 (2条)
管理程序 (4条)