FDA 为公众健康而确保药品质量_Uratan.pdf

Ensuring Drug Quality for Public Health The Implementation 为公众健康而确保药品质量 Brenda Uratani, Ph.D. Assistant Country Director FDA China Office, Beijing 1 Overview 概述 • Challenges to Globalization of Drug Manufacturing 药品生产的全球化挑战 • FDA’s Work in China FDA 在中国的工作 • GMP Principles: Issues of the most concern GMP 原则：最关注的问题 2 Challenges 挑战 • Significant demand in resources for inspections 检查资源的重大需求 • Consequences of globalization, including more foreign manufacturing and clinical trials sites 全球化结果，包括更多的国外生产及临床试验场地 • Greater complexity associated with manufacturing 药品生产更复杂 • FDA concern about the state of industry compliance and insufficient investment in manufacturing and quality systems FDA 关注行业符合状态及生产/质量系统投资不足 3 FDA International Efforts FDA全球性成绩 4 FDA Overseas Efforts FDA 的海外成绩 Long-Term Goal 长期目标 • Products coming to the U.S. meet U.S. requirements. 产品进入美国,符合美国要求 • Strengthened Regulatory Counterparts 提高合作监管机构的能力 • Industry Responsibility: Supply Chain Management at Point of Manufacture, Point of Export, and When Presented for Importation 行业职责：在生产点，出口点及进口点的供应链管理 5 FDA Overseas Presence FDA的海外存在 Current Locations 目前位置 • China 中国 • India 印度 • Latin America 拉丁美洲 • Europe 欧洲 • Middle East (2010) 中东 （2010 ）