forHumanDrugs人用药品企业注册和产品列表.PDF

Establishment Registration and Listing for Human Drugs 人用药品企业注册和产品列表 Highlighting Recent Amendments to 21 CFR Part 207 侧重最近对21篇207部分的修订 David Joy and Paul Loebach FDA, Center for Drug Evaluation and Research September 2016 FDA药品审评与研究中心 2016年9月 Overview 内容介绍 Topics we’ll cover in this presentation include: 本次发言涵盖的内容包括： • Basic background on drug registration listing 药品注册和列表的背景 • Things that are new in the amended regulations • 修订后法规中的新内容 • How does electronic submission work? 如何进行电子提交？ • Compliance deadlines for the new requirements • 必须符合新要求的截止日期 • Topics of special interest: 某些主题的内容 – Private Label Distributors (PLDs) 贴标分销商 – Unique Facility Identifiers (UFIs) 唯一企业识别码 – “No changes” certifications “无变更”证明 – NDCs on drug labels 药品标签上的NDC 2 Basic background on drug registration listing: 药品注册和列表背景介绍 What is drug establishment registration and what does it involve? 什么是药品企业注册，药品企业注册涉及什么内容？ • Statutory obligation dating back to 1962 • 1962年的法规要求 • What triggers the establishment registration obligation? • 企业注册责任是如何产生的？ • Who is exempt from drug establishment registration? • 谁可以被豁免而不进行药品企业注册？ • What information is submitted to FDA to register a drug establishment? • 注册药品企业需要向FDA提交什么信息？ • How often does the information get updated or renewed? • 信息更新的频率如何？ – Annual registration 年度注册 – Updates when information changes 如有信息变更进行的更新 • Who is exempt from drug establishment registration? • 谁可以被豁免而不进行药品企业注册？ • How does establishment registration apply to foreign drug establishments? • 企业注册如何适用于美国境外药品企业？ 3