目的 了解日本儿童用药监管策略及具体监管情况。方法 通过文献调研的方法分析了日本的儿童用药的监管机构及具体的监管措施等情况。结果 发现日本的儿童用药的监管方式及监管策略都有其独特性。结论 日本根据具体情况采取了不同的策略进行儿童用药的监管并采取了许多具体的措施促进其发展。
Abstract
OBJECTIVE To understand the current status of pediatric drug regulatory strategies and detailed regulatory measures in Japan.METHODS Pediatric drug regulatory institutions and specific regulatory measures in Janpan were analyzed based literature review. RESULTS Janpan had unique regulatory strategies and measures on pediatric drugs. CONCLUSION In accordance with its specific conditions, Janpan has adopted various strategies and measures for regulation and development of pediatric drugs.
关键词
日本 /
儿童用药 /
监管策略
{{custom_keyword}} /
Key words
Janpan /
pediatric drug /
regulatory strategy
{{custom_keyword}} /
中图分类号:
R95
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] CHEN Y M. Pharmacovigilance for special populations . Chin J Pharmacoepidemiol(药物流行病学杂志),2011, 20(6):315-317.[2] Food and Drug Administration, Center for Drug Evaluation and Research ( CDER). Guidance for Industry:The Content and Format for Pediatric Use Supplements . . http://www. fda. gov /downloads /Drugs /Guidance Compliance Regulatory-Information / Guidances /ucm071957.[3] Food and Drug Administration. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Final Rule. . http://www. fda. gov /ohrms /dockets /98fr /120298c.[4] Food and Drug Administration. In Proceedings of 107th Congress of the United States of America. . http://www. fda. gov /downloads /Drugs /DevelopmentApprovalProcess /DevelopmentResources/UCM049874. [5] European Medicines Agency. Regulation (EC) No 1902 /2006 an amending regulation in which changes to the original text were introduced relating to decision procedures for the European Commission . . http://ec.europa. eu/health /files /eudralex /vol-1 /reg_2006_1902 /reg_2006_1902_en. [6] WANG C, MI X Q. Introduction on administration and supervision of medical devices in Japan. China Med Dev Inf(中国医疗器械信息), 2009, 15(2):26-29.[7] ZHANG S. Tasks of Japanese pediatric drug use committee. VIP Information(维普资讯), 2007, 34(3):16.[8] YANG Z M, ZHANG P P. Current status and characteristics of examination and approval of pediatric drugs in foreign countries. Chin Pharm J(中国药学杂志), 2012, 47(10):745-748.[9] HU Y J, SONG R L, SHAO R, et al. Overview and development trends of foreign and domestic pharmaceutical laws and regulations. China Pharm(中国药师), 2004,7(11):890-892.[10] English Regulatory Information Task Force Japan Pharmaceutical Manufacturers Association.PharmaceuticalAdministration and Regulations in Japan. http://www.jpma.or.jp/english/parj/1003.html.[11] NAKAMURA H, OZAKI M. Facilitation of Pediatric Research in Japan. The Global Framework of Peadiatric Drug Developement, 2010, 15-22.[12] Drug Therapy Committee of the Japan Pediatric Society. Survey of the current state of pediatric drug use in Japan (1994-6). Pediatric Int, 2000, 42(1):109-113.[13] HOPPU K, ANABWANI G, GARCIA-BOURNISSEN F, et al. The status of pediatric medicines initiatives around the world-What has happened and what has not? . Eur J Clin Pharmacol, 2012, 68(1):1-10. [14] TIAN C H, SHEN L. The pediatric drug research and drug safety . Chin J Pharmacovigilance(中国药物警戒), 2009,6(9):518-521.[15] ZHANG X L, LIU L. Introduction of the current status of drug registration system in Japan. Chin Pharm Aff(中国药事), 2002, 16(10):645-646.[16] ZHAO Y S. Current status and development of medical and drug administration in Japan. China Health Insurance (中国医疗保险), 2009(9):63-66.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}