Harmonization of immunotoxicology study guidelines  

作　　者：NakaK 

机构地区：[1]ImmunotoxicologyWorkingGroup,JapanPharmaceuticalManufacturesAssociation,Osaka,Japan

出　　处：《中国药理学与毒理学杂志》2002年第6期408-409,共2页Chinese Journal of Pharmacology and Toxicology

摘　　要：Guidance for immunotoxicology studies has been intensively discussed.The European Medicnes Evaluation Agency published the draft guidance on immunotoxicity on December 16,1999 and finalized it on July 27,2000.In the meantime,the US Food and Drug Administration (FDA) published the draft guidance on May 11,2001.The Japanese Ministry of Health,Labor and Welfare and the Japan Pharmaceutical Manufactures Association submitted their interim draft guidance to the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH) for discussion of Decemeber 20,2001.The approaches are taken in these(draft) guidance documents.A major difference among the guidance of the three regions is that only the EU guidance requires some immune function tests for all new medicinal products.The informal expert working proup meeting held in the ICH on February 7,2002 resched the conchusion that the guidelines should be eventually hamonized after collecting more data.A scientific session on immunotoxicity testing will be included in the ICH6,Osake,November 2003.

关 键 词：免疫毒理学 研究方法 指南 

分 类 号：R994[医药卫生—毒理学]