FDA新发布的DHCP信函格式和内容指导原则介绍

Introduction to DHCP letter format and content guidance recently issued by FDA

亲爱的卫生保健提供者(DHCP)信函由药品生产商或美国食品药品管理局(FDA)迅速直接发给医生和其他需要者,传递药品说明书变化,分为重要药物警告信、重要处方资料信和重要药品信息更正信3种形式。2017年2月FDA发布了"DHCP信函:改善重要安全信息沟通的指导原则",详细说明了3种信函撰写的内容和格式并列举了范本。介绍该指导原则的主要内容,呼吁我国药品生产企业和药政管理部门借鉴FDA经验,建立符合我国国情的相应机制,使医生和其他需要者能及时获得药品说明书重要的新信息,确保临床用药安全有效。

Dear Health Care Provider （DHCP） letters promptly are directed to doctors and other demanders by manufacturer or FDA to communicate change of description drug labeling,which are divided into three types-Important Drug Warning Letters,Important Prescribing Information Letters,and Important Correction of Drug Information Letters.FDA issued Guidance for Industry and FDA Staff Dear Health Care Provider Letters：Improving Communication of Important Safety Information in February 2017,described in detail the contents and format of the three letters;and listed the models.This paper introduces the main contents of the guidance.Call on China＇s pharmaceutical production enterprises and regulatory agency from the FDA experience establish the corresponding mechanism in line with China＇s national conditions,so that doctors and other demanders can be timely access to important new information of labeling to ensure clinical safe and effective medication.