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.
CHEN Wei,
ŷYang-Zhao-Lian,
GUO Wen-Jiao etc
.Study on Pediatric Drug Regulatory Strategies in Japan[J] Chinese Pharmaceutical Journal, 2014,V49(7): 618-621
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[1]
CHEN Y M. Pharmacovigilance for special populations . Chin J Pharmacoepidemiol(ҩ�����в�ѧ��־),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(�й�ҽ����е��Ϣ), 2009, 15(2):26-29.[7] ZHANG S. Tasks of Japanese pediatric drug use committee. VIP Information(ά����Ѷ), 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(�й�ҩѧ��־), 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(�й�ҩʦ), 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(�й�ҩ�ﾯ��), 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(�й�ҩ��), 2002, 16(10):645-646.[16] ZHAO Y S. Current status and development of medical and drug administration in Japan. China Health Insurance (�й�ҽ�Ʊ���), 2009(9):63-66.
2014, Vol. 49 
