FDA Globalization: Inspection Presence in India and China FDA全球化检查:印度和中国 34TH INTERNATIONAL GOOD MANUFACTURING PRACTICES CONFERENCE 第34届国际GMP会议 University of ia College of Pharmacy Athens, GA 乔治亚州制药大学 March 15-18, 2010 2010年03月15日~18日
Edwin Rivera-Martinez
Acting Associate Director, Drug Quality Assurance 药品质量保证代理副总监
Division of Manufacturing & Product Quality 生产&产品质量分部
Office pliance 达标办公室
Center for Drug Evaluation & Research 药品评估&研究中心
1
FDA’s Statutory Mission FDA的法定任务
SEC. 903. [ 21 . 393] FOOD AND DRUG ADMINISTRATION. 食品药品监督管理局
(b) —The Administration shall 此管理局应—
(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;
通过迅速和有效的检查临床研究,对所管制产品的上市及时采取适当的措施,促进公共健康;
(2) with respect to such products, protect the public health by ensuring that—
对于这些产品,通过确保以下几项,来保护公共健康--
(A) foods are safe, wholesome, sanitary, and properly labeled;
食品安全、卫生、健康,并有适当标识;
(B) human and veterinary drugs are safe and effective;
人用药和兽用药安全并有效;
(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use;
可合理确保:人用器械的安全性和有效性;
(D) cosmetics are safe and properly labeled; and
化妆品安全并有适当标识;
(E) public health and safety are protected from electronic product radiation;
保护公共健康和安全,以免受电子产品的辐射;
2
FDA’s Statutory Mission FDA的法定任务
(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
与其它国家的代表一起,通过相应的流程,参与减少法规压力、协调法规要求及完成相应的互惠性商议。
3
Basic Principal:基本原则 International Cooperative Activities 国际合作活动
Leverage/create synergies with the human, scientific, and financial resources and the knowledge and experience of other key regulatory authorities to promote and protect public health by:
杠杆作用/依靠人类、科学和财政资源及其它关键法规机构的知识和经验,创造协同,通过以下几项,来促进和保护公共健康:
avoiding duplication of e
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