EMA对草药产品申请上市许可或注册的非临床资料的要求

EMA于2017年8月发布了"公认和传统草药产品申请上市许可或注册的非临床文件的指导原则（草案）"。该指导原则指出传统和公认的草药物质或制剂,在获得人体充分而详实经验的情况下,单次给药和重复给药毒性、毒代动力学研究、免疫毒性以及局部耐受性试验是不必要的;而其生殖毒性、遗传毒性和致癌性,如果发表的文献不能用或不足,附加非临床试验是必要的。详细介绍该指导原则主要内容,以期对拟在欧盟上市的中草药产品有所帮助,也对我国草药监管有所启发。

EMA requirements for non clinical information on herbal products in applications for marketing authorisation/registration

EMA in August 2017 issued "guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products (Draft)", which pointed that it is no necessary to carry out the test of single dose and repeated dose toxicity, toxicokinetic studies, immunotoxicity as well as local tolerance of traditional and well-established herbal substances or preparations under the condition that sufficient and well-documented experience is available in humans. However, additional non-clinical testing would be necessary, if the content of the toxicity of reproduction, genotoxicity and carcinogenicity in the published literature is not available or insufficient. This article describes the guideline in detail and is expected to be a direct help to the traditional Chinese medicines and herbal medicines that are intended to be marketed in the European Union, as well as to have inspiration on the supervision.