Responsible Institution: China Association for Science and Technology
Sponsored by: The Chinese Pharmacological Society
Editor-in-Chief: HUANG Zhili
ISSN 1009-2501
CN 34-1206/R
Internationally agreed medical terminology :Medical Dictionary for Regulatory Activities
BO Qing-yan1,2, XIONG Ning-ning2, ZOU Jian-dong2, JIANG Meng2, LIU Fang2, Anna Zhao-Wong3
1Nanjing University of TCM, 2Department of Clinical Pharmacology, Affiliated Hospital of Nanjing University of TCM,Nanjing 210029, Jiangsu, China; 3MedDRA MSSO, 12011 Sunset Hills Road, Reston, VA 20190, USA
BO Qing-yan, XIONG Ning-ning, ZOU Jian-dong, JIANG Meng, LIU Fang, Anna Zhao-Wong. Internationally agreed medical terminology :Medical Dictionary for Regulatory Activities[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2007, 12(5): 586-590.
1 International Conference on Harmonisation ( ICH).MedDRA( r) Term Selection:Points to Consider:ICH-Endorsed Guide for MedDRA Users[S].Release 3.4.Basel, Switzerland, 2004:11. 2 Safety Reporting Requirements for Human Drug and Biological Products.Proposed Rule 68[S].Fed Regist, 2003;50:12405-12497. 3 Kubler J, Vonk R, Beimel S, et al.Adverse event analysis and MedDRA:business as usual or challenge [J] ? Drug Inf J,2005 ;39:63-72. 4 Mozzicato P.MAGs:a new-and improved-way of thinking[S].MedDRA Messenger, 2002:September. 5 中国CIPRA 通讯[EB OL].Available from URL:http: www.ciprancaids.org.cn2004:11 ;[Accessed May 28, 2006] 6 International Conference on Harmonisation ( ICH).MedDRA Data Retrieval and Presentation:Points to Consider:ICH-Endorsed Guide forMedDRA Users[S].release 1.0.Basel, Switzerland,2004:11.