中药皮肤外用制剂非临床安全性评价的特殊考虑

Special Consideration for Preclinical Safety Assessment of TCM Topical Preparations

新修订《药品注册管理办法》将以配套文件的形式发布新药研发的指导原则和技术要求。目前急需完善非临床安全性评价等技术要求,以更加有效地促进中药品种研发。本文结合国内外相关技术指导原则,简单综述中药皮肤外用制剂非临床安全性评价与化学药品的相同点和特殊关注点,以供业界参考。

After issuance of the newly-revised Provisions for Drug Registration,technical guidelines on new drug development will be issued separately as supporting documents.Technical requirements for non-clinical safety assessment need to be updated to promote development of traditional Chinese medicines(TCM)products.Based on an overview of relevant domestic and foreign technical guidelines,this article compares similarities of and special consideration for preclinical safety assessment between TCM topical preparations and chemical drugs,providing reference for industry.