美国食品药品管理局（FDA）于2018年4月发布了"供企业用的严重衰弱或危及生命的血液病：药物非临床研发指导原则"。该指导原则描述了这类药物简化的非临床研究方案，我国目前尚无类似的指导原则。详细介绍该指导原则，以期对我国这类药物非临床研究和评价有帮助。

FDA issued "Severely Debilitating or Life-Threatening Hematologic Disorders:Nonclinical Development of Pharmaceuticals Guidance for Industry" in April 2018.The guideline described a streamlined nonclinical study program of these drugs.At present,there is no similar guidance in our country.This article introduces the guidance in detail and expects to be helpful for the non-clinical study and evaluation of these drugs in China.