Sage Journals: Discover world-class research

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Review article

First published 2013-5

Transparency at the EMA

Ragnar E. Löfstedt

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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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 2024-02

Report of the European Medicines Agency Conference on RNA-Based Medicines

Falk Ehmann, Andreas Kuhn, Anna Maria Gerdina Pasmooij [...]

Nucleic Acid Therapeutics

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Research article

First published 2011-11

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: application to diabetes and vascular disease

Kevin V Blake, Camilla Smeraldi, Xavier Kurz [...]

The British Journal of Diabetes & Vascular Disease

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Research article

First published 2019-2

A Sequel to the Eteplirsen Saga: Eteplirsen Is Approved in the United States but Was Not Approved in Europe

Annemieke Aartsma-Rus, Nathalie Goemans

Nucleic Acid Therapeutics

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Research article

First published 2016-9

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007-2013

Gunter F. Egger, Gerold T. Wharton, Suzanne Malli [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019-3

Regulatory/Scientific Supports for Micro-,Small-,and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA

Hideyuki Kondo, Masayoshi Shibatsuji, Naoyuki Yasuda

Therapeutic Innovation & Regulatory Science

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Research article

First published 2026-3

Liposome drug development as complex pharmaceuticals: Current regulatory aspects in USA and EU

Alishanaz I Subedar, Fazal M. Tai

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2014-5

Comparison of Drug Approvals in Europe Versus the United States

Robert W. Makuch, Ruizhi Shi

Therapeutic Innovation & Regulatory Science

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