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1-10 of 191 results for Japan regulatory

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Select article: The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan

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Research article

First published 2013-1

The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan

Yasuko Asahina, Ayumi Tanaka, Yoshiaki Uyama [...]

Therapeutic Innovation & Regulatory Science

Select article: Prospects for Harmonizing Regulatory Science Programs in Europe,Japan,and the United States to Advance Regenerative Medicine

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Research article

First published 2016-11

Prospects for Harmonizing Regulatory Science Programs in Europe,Japan,and the United States to Advance Regenerative Medicine

Christopher-Paul Milne, James Mittra, Naoko Kojima [...]

Therapeutic Innovation & Regulatory Science

Select article: Regulatory Requirements and Practices for Clinical Studies in Japan

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Research article

First published 1992-7

Regulatory Requirements and Practices for Clinical Studies in Japan

Noriaki Murao

Therapeutic Innovation & Regulatory Science

Select article: Approval Status and Regulatory Actions for Radiopharmaceuticals in the United States and Japan

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Research article

First published 2014-9

Approval Status and Regulatory Actions for Radiopharmaceuticals in the United States and Japan

Nobuyuki Hanamura, Atsushi Aruga

Therapeutic Innovation & Regulatory Science

Select article: Emergency Authorization of Medical Products: Regulatory Challenges from the 2009 H1N1 Influenza Pandemic in Japan

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Research article

First published 2012-12

Emergency Authorization of Medical Products: Regulatory Challenges from the 2009 H1N1 Influenza Pandemic in Japan

Hisashi Urushihara, Sayako Matsui, Koji Kawakami

Health Security

Select article: Regional Differences During the ICH Regulatory Consultation Process Between the EU,US,and Japan

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Research article

First published 2018-7

Regional Differences During the ICH Regulatory Consultation Process Between the EU,US,and Japan

Aimad Torqui, Alina Mihaela Macau

Therapeutic Innovation & Regulatory Science

Select article: Regulatory brokerage: Competitive advantage and regulation in the field of regenerative medicine

Open access

Research article

First published 2019-6

Regulatory brokerage: Competitive advantage and regulation in the field of regenerative medicine

Margaret Sleeboom-Faulkner

Social Studies of Science

Select article: Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach

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Research article

First published 2016-5

Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach

Kiyohito Kuno, Satoshi Toyoshima

Therapeutic Innovation & Regulatory Science

Select article: Regulatory Aspects of Biotechnology in Japan

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Research article

First published 1990-1

Regulatory Aspects of Biotechnology in Japan

Akira Kawahara

Therapeutic Innovation & Regulatory Science

Select article: eBusiness in regulatory pharmaceuticals in Japan

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Research article

First published 2001-8

eBusiness in regulatory pharmaceuticals in Japan

Mihoko Okada, Shigekoto Kaihara

Pharmaceuticals Policy and Law

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