Document Detail

Emergency Authorization of Medical Products: Regulatory Challenges from the 2009 H1N1 Influenza Pandemic in Japan.
MedLine Citation:
PMID:  23210832     Owner:  NLM     Status:  Publisher    
In response to the 2009 H1N1 influenza pandemic, the governments of Japan and the United States for the first time authorized the emergency use of unapproved drugs. In this article, we comprehensively review the different regulatory approaches of Japan and the United States, countries with advanced regulatory and healthcare systems, to emergency authorization of the use of medical products as a countermeasure to public health emergencies. We outline the legal system, range of targeted products, requirements for the application dossier, legal stance for authorization, product availability, and termination of the Japanese Emergency Approval (EA), and we compare characteristics with those of the US Emergency Use Authorization (EUA). We also review the actual cases of these 2009 emergency authorizations. The Japanese EA importation of novel H1N1 influenza vaccines with adjuvant is presented, with lessons learned, and contrasted with the US EUA of peramivir.
Hisashi Urushihara; Sayako Matsui; Koji Kawakami
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-4
Journal Detail:
Title:  Biosecurity and bioterrorism : biodefense strategy, practice, and science     Volume:  -     ISSN:  1557-850X     ISO Abbreviation:  Biosecur Bioterror     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101156085     Medline TA:  Biosecur Bioterror     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Hisashi Urushihara, DrPH, is an Assistant Professor; Sayako Matsui, MS, is a doctoral student; and Koji Kawakami, MD, PhD, is Professor and Chairman; all in the Department of Pharmacoepidemiology, School of Medicine and Public Health, Kyoto University , Kyoto, Japan .
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