目录1。Introduction ............................................................................................................................. 6 2.Scope ....................................................................................................................................... 6 3.Definitions ............................................................................................................................... 8 4.Part A: Preclinical data requirements .................................................................................... 11 4.1.New drug applications ....................................................................................................... 11 4.2.New generic drug application ............................................................................................ 12 4.3.Impurities ........................................................................................................................... 13 4.3.1.Qualification of Organic Impurities ............................................................................... 13 4.3.1.1.Mutagenicity Assessment of Impurities ..................................................................... 14 4.3.2.Qualification of Residual Solvents and Elemental Impurities ....................................... 14 5.Part B: Writing Guide for Non-clinical Study Reports ......................................................... 15 5.1.Documents Format ............................................................................................................. 15 5.3.非临床书面和列表摘要...........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................非临床研究报告.......................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Appendices ............................................................................................................................ 22