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Research article

First published 2013-7

Good Laboratory Practice Inspections in Japan Between Fiscal Years 2009-2011

Reiko Anahara

Therapeutic Innovation & Regulatory Science

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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

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Other

First published 2009-1

Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years

Kazuhiko Mori, Sotoshi Toyoshima

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-5

A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products

Hideyuki Kondo, Toshiki Sugita, Naoko Ida [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 2009-7

Electronic Common Technical Document Implementation in Japan

Kiyohito Nakai, Yasuhiro Araki, Daigoro Ebina [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-3

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU

Hideyuki Kondo, Agnès Saint-Raymond, Naoyuki Yasuda

Therapeutic Innovation & Regulatory Science

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Research article

First published 2014-3

Evolving Global Regulatory Science Through the Voluntary Submission of Data

Elizabeth Gribble Walker, Martha Brumfield, Carolyn Compton [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 2010-1

Discussion Based on the Survey Results of Authorities' Inquiries during NDA Review in Japan

Reiko Numazaki, Kazumi Sunamura, Chikara Kikuthi [...]

Therapeutic Innovation & Regulatory Science

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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

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Research article

First published 2018-11

What Drives Adoption of National Labels as Global Reference Labels? A Case Study With the JPI

Shimon Yoshida, Rie Matsui, Chikara Kikuchi

Therapeutic Innovation & Regulatory Science

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