Emergency authorization of medical products

Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan

Hisashi Urushihara, Sayako Matsui, Koji Kawakami

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)372-382
Number of pages11
JournalBiosecurity and Bioterrorism
Volume10
Issue number4
DOIs
Publication statusPublished - 2012 Dec 1
Externally publishedYes

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influenza
authorization
Pandemics
Human Influenza
contagious disease
Japan
Emergencies
Vaccines
Public health
Availability
regulatory approach
legal system
vaccine
health care
public health
drug
authorisation
product
Influenza Vaccines
Public Health

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health(social science)
  • Management, Monitoring, Policy and Law

Cite this

Emergency authorization of medical products : Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan. / Urushihara, Hisashi; Matsui, Sayako; Kawakami, Koji.

In: Biosecurity and Bioterrorism, Vol. 10, No. 4, 01.12.2012, p. 372-382.

Research output: Contribution to journalArticle

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