Emergency authorization of medical products: Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan
Hisashi Urushihara, Sayako Matsui, Koji Kawakami
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.
Biosecurity and Bioterrorism
https://doi.org/10.1089/bsp.2012.0017
10.1089/bsp.2012.0017
Fingerprint Dive into the research topics of 'Emergency authorization of medical products: Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan'. Together they form a unique fingerprint.
pandemics Earth & Environmental Sciences
authorization Earth & Environmental Sciences
influenza Earth & Environmental Sciences
Pandemics Medicine & Life Sciences
contagious disease Social Sciences
Human Influenza Medicine & Life Sciences
Emergencies Medicine & Life Sciences
Urushihara, H., Matsui, S., & Kawakami, K. (2012). Emergency authorization of medical products: Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan. Biosecurity and Bioterrorism, 10(4), 372-382. https://doi.org/10.1089/bsp.2012.0017
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.
Urushihara, H, Matsui, S & Kawakami, K 2012, 'Emergency authorization of medical products: Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan', Biosecurity and Bioterrorism, vol. 10, no. 4, pp. 372-382. https://doi.org/10.1089/bsp.2012.0017
Urushihara H, Matsui S, Kawakami K. Emergency authorization of medical products: Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan. Biosecurity and Bioterrorism. 2012 Dec 1;10(4):372-382. https://doi.org/10.1089/bsp.2012.0017
Urushihara, Hisashi ; Matsui, Sayako ; Kawakami, Koji. / Emergency authorization of medical products : Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan. In: Biosecurity and Bioterrorism. 2012 ; Vol. 10, No. 4. pp. 372-382.
@article{3e19b6c0474a4662b2d910322588caec,
title = "Emergency authorization of medical products: Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan",
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.",
author = "Hisashi Urushihara and Sayako Matsui and Koji Kawakami",
doi = "10.1089/bsp.2012.0017",
journal = "Health security",
publisher = "Mary Ann Liebert Inc.",
T1 - Emergency authorization of medical products
T2 - Regulatory challenges from the 2009 H1N1 influenza pandemic in Japan
AU - Urushihara, Hisashi
AU - Matsui, Sayako
AU - Kawakami, Koji
N2 - 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.
AB - 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.
U2 - 10.1089/bsp.2012.0017
DO - 10.1089/bsp.2012.0017
JO - Health security
JF - Health security