FDA建立与申请人沟通的会议制度的经验对我国新药审批的启示(9)

参考文献

[1] U.S. Food and Drug Administration. “White Paper Prescription Drug User Fee

Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications”, U.S. FDA Website, 11 July 2009. http://www.fda.gov/ [2] Food and Drug Administration Modernization Act of 1997. U.S. FDA Website,

11 July 2009. http://www.fda.gov/ [3] Bioterrorism Act of 2002. U.S. FDA Website, 10 July 2009. http://www.fda.gov/ [4] Guidance for Review Staff and Industry: Good Review Management Principles

and Practices for PDUFA Products. U.S. FDA Website, 29 September 2009. http://www.fda.gov/ [5] Federal Food Drug and Cosmetic Act. U.S. FDA Website, 10 July 2009.

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Drug Administration: Part 10: Administrative Practices and Procedures. U.S. FDA Website, 1 April 2009. http://www.accessdata.fda.gov/ [7] Code of Federal Regulations Title 21-- Food and Drugs: Chapter 1--Food and

Drug Administration: Part 312: IND application. U.S. FDA Website, 1 April 2009. http://www.accessdata.fda.gov/ [8] Guidance for Industry: Formal Meeting With Sponsors and Applicants for

PDUFA Products. U.S. FDA Website, 29 September 2009. http://www.fda.gov/ [9] Guidance for Industry: Formal Meetings Between the FDA and Sponsors or

Applicants. U.S. FDA Website, 29 September 2009. http://www.fda.gov/ [10] Michael A. Swit, Esq. “Successful FDA Meetings”, DIA West Coast Drug

Development Conference, San Francisco, CA, 25 October 2004. [11] DiMasi, Joseph A., Hansen, Ronald W., and Grabowski, Henry G. “The Price

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[13] Reichert, J.M. “Trends in Development and Approval Times for New

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通交流 促进审评公开透明”, 国家食品药品监督管理局网站, 2009年2月23日. http://www.sfda.gov.cn/ [19] Feng Yi. “Multinational Clinical Trial Review and Administration in China”,

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http://www.china.com.cn/

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附录 缩略语

ADME

ANDA

BLA

CBER

CDE

CDER

21CFR

CMC

CTD

e-CTD

FDA

FDAMA FFDCA

GMMPs

Absorption, Distribution, Metabolism and Excretion 吸收、分布、代谢、排泄

Abbreviated New Drug Application 简略新药申请

Biologics License Application 生物制品许可申请

Center for Biologics Evaluation and Research 生物制品审评和研究中心

Center for Drug Evaluation 药品审评中心

Center for Drug Evaluation and Research 药品审评和研究中心

Code of Federal Regulations Title 21 美国联邦法规第21部

Chemistry, Manufacturing and Control 化学、生产和控制（药学研究资料）

Common Technical Document 通用技术文件

Electric Common Technical Document 电子化的通用技术文件

Food and Drug Administration 美国食品和药品管理局

Food and Drug Administration Modernization Act

食品和药品管理局现代化法案

Federal Food, Drug and Cosmetic Act 美国联邦食品、药品和化妆品法案

Good Meeting Management Practices

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GRMPs

GRP

ICH

IND

NDA

PDUFA

PK/PD

RDPAC

SFDA

会议管理规范

Good Review and Management Principles and Practices 药品审评管理原则和实践规范 Good Review Practice 药品审评管理规范

International Conference On Harmonisation Of Technical

Requirements For Registration Of Pharmaceuticals For Human Use 国际人用药品注册技术要求协调会议 Investigational New Drug 新药临床研究申请 New Drug Application 新药上市申请

Prescription Drug User Fee Act 处方药用户付费法案

Pharmacokinetics/Pharmacodynamics 药代动力学/药效学研究

R&D Based Pharmaceutical Association Committee 研制开发制药企业协会

State Food and Drug Administration 国家食品药品监督管理局

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