FDA“药物升压效应评估”供企业用的指导原则草案(第1次修订版)介绍  

Introduction to FDA's Assessment of Pressor Effects of Drugs Draft Guidance for Industry(revision 1)

作　　者：萧惠来 XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2022年第7期1255-1260,共6页Drug Evaluation Research

摘　　要：血压升高可增加卒中、心脏病发作和死亡的风险,美国食品药品监督管理局(FDA)主张将评估药物对血压的作用纳入药物风险评估。为此,FDA于2018年5月发布了“药物升压效应评估”供企业用的指导原则草案,提出了有关药物对血压作用上市前评估的建议。2022年2月,FDA又发布了该指导原则草案的第1次修订版,增加了对研究设计的许多细节的建议,还增加了对其评估结果列入药品说明书的具体建议。中国目前还没有类似的指导原则,详细介绍该指导原则的修订版内容,期待国内的药物研发人员对此予以重视,主动将新药对血压的影响列入药物临床风险研究;也期待药品监管部门制定相应的法规和指导原则。Elevated blood pressure increases the risk of stroke,heart attack and death.FDA advocates that the evaluation of the effect of drugs on blood pressure should be included in the drug risk assessment.Therefore,in May 2018,FDA issued the Assessment of Pressor Effects of Drugs Draft Guidance for Industry,and put forward suggestions on the premarketing assessment of a drug's effect on blood pressure.Four years later,in February 2022,FDA issued the first revision of the draft guidance,adding suggestions on many details of the study design and specific suggestions on the inclusion of the evaluation results in the drug labelings.At present,there is no similar guidance in China.This paper introduces the revised version of the guidance in detail,and expects the researchers of drug development in China to pay attention to it and take the initiative to include the effect of the developed drugs on blood pressure in the clinical risk study of drugs.At the same time,China's drug regulatory authorities are expected to put forward regulatory requirements and formulate corresponding regulation and guidance.

关 键 词：食品药品监督管理局 药物升压效应 上市前评估 药品说明书 指导原则 

分 类 号：R951[医药卫生—药学]