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The Roadmap to Approval under Japan's Two-Track Regulatory System: Comparing Six Regenerative Medical Products.
Matsushita, Shunsuke; Tachibana, Keisuke; Kusakabe, Tetsuya; Hirayama, Ryuichi; Tsutsumi, Yasuo; Kondoh, Masuo.
Afiliação
  • Matsushita S; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka 567-0871, Japan.
  • Tachibana K; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka 567-0871, Japan.
  • Kusakabe T; Graduate School of Medicine, Osaka City University, Osaka 545-0051, Japan.
  • Hirayama R; Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan.
  • Tsutsumi Y; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka 567-0871, Japan.
  • Kondoh M; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka 567-0871, Japan. Electronic address: masuo@phs.osaka-u.ac.jp.
Cell Stem Cell ; 27(4): 515-518, 2020 10 01.
Article em En | MEDLINE | ID: mdl-33007235
ABSTRACT
The Japanese conditional and time-limited (CTL) approval framework, a tiered system for regenerative medical products, was initiated in 2014. Here, we compare the dossiers of six regenerative medical products with either direct full approval or CTL approval, and we discuss the regulatory considerations for obtaining approval under the CTL approval framework.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicina Regenerativa Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicina Regenerativa Idioma: En Ano de publicação: 2020 Tipo de documento: Article