Emergency authorization of medical products: regulatory challenges from the 2009 H1N1 influenza pandemic in Japan.
Identifieur interne : 000C92 ( PubMed/Checkpoint ); précédent : 000C91; suivant : 000C93Emergency authorization of medical products: regulatory challenges from the 2009 H1N1 influenza pandemic in Japan.
Auteurs : Hisashi Urushihara [Japon] ; Sayako Matsui ; Koji KawakamiSource :
- Biosecurity and bioterrorism : biodefense strategy, practice, and science [ 1557-850X ] ; 2012.
Descripteurs français
- KwdFr :
- Agrément de médicaments (législation et jurisprudence), Antiviraux (usage thérapeutique), Cyclopentanes (usage thérapeutique), Grippe humaine (épidémiologie), Guanidines (usage thérapeutique), Humains, Japon, Pandémies (législation et jurisprudence), Sous-type H1N1 du virus de la grippe A (immunologie), Urgences, Vaccins antigrippaux, États-Unis d'Amérique.
- MESH :
- immunologie : Sous-type H1N1 du virus de la grippe A.
- législation et jurisprudence : Agrément de médicaments, Pandémies.
- usage thérapeutique : Antiviraux, Cyclopentanes, Guanidines.
- épidémiologie : Grippe humaine.
- Humains, Japon, Urgences, Vaccins antigrippaux, États-Unis d'Amérique.
- Wicri :
- geographic : Japon, États-Unis.
English descriptors
- KwdEn :
- Antiviral Agents (therapeutic use), Cyclopentanes (therapeutic use), Drug Approval (legislation & jurisprudence), Emergencies, Guanidines (therapeutic use), Humans, Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines, Influenza, Human (epidemiology), Japan, Pandemics (legislation & jurisprudence), United States.
- MESH :
- chemical , therapeutic use : Antiviral Agents, Cyclopentanes, Guanidines.
- geographic : Japan, United States.
- epidemiology : Influenza, Human.
- immunology : Influenza A Virus, H1N1 Subtype.
- legislation & jurisprudence : Drug Approval, Pandemics.
- Emergencies, Humans, Influenza Vaccines.
Abstract
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.
DOI: 10.1089/bsp.2012.0017
PubMed: 23210832
Affiliations:
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type="abstract" xml:lang="en">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. 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The Japanese EA importation of novel H1N1 influenza vaccines with adjuvant is presented, with lessons learned, and contrasted with the US EUA of peramivir.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">23210832</PMID><DateCompleted><Year>2013</Year><Month>06</Month><Day>05</Day></DateCompleted><DateRevised><Year>2015</Year><Month>02</Month><Day>19</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1557-850X</ISSN><JournalIssue CitedMedium="Internet"><Volume>10</Volume><Issue>4</Issue><PubDate><Year>2012</Year><Month>Dec</Month></PubDate></JournalIssue><Title>Biosecurity and bioterrorism : biodefense strategy, practice, and science</Title><ISOAbbreviation>Biosecur Bioterror</ISOAbbreviation></Journal><ArticleTitle>Emergency authorization of medical products: regulatory challenges from the 2009 H1N1 influenza pandemic in Japan.</ArticleTitle><Pagination><MedlinePgn>372-82</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1089/bsp.2012.0017</ELocationID><Abstract><AbstractText>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. 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last="Matsui">Sayako Matsui</name></noCountry><country name="Japon"><region name="Région du Kansai"><name sortKey="Urushihara, Hisashi" sort="Urushihara, Hisashi" uniqKey="Urushihara H" first="Hisashi" last="Urushihara">Hisashi Urushihara</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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