Literature DB >> 25842975

Conditional approval: Japan lowers the bar for regenerative medicine products.

Douglas Sipp1.   

Abstract

A new system for conditional approval of regenerative medicine products will allow products of undetermined efficacy to enter the Japanese market. The potential scientific, economic, and ethical implications of this program highlight the need for further discussion and refinement.
Copyright © 2015 Elsevier Inc. All rights reserved.

Mesh：

Year:  2015        PMID： 25842975     DOI： 10.1016/j.stem.2015.03.013

Source DB:  PubMed          Journal:  Cell Stem Cell        ISSN： 1875-9777            Impact factor:   24.633


  16 in total

Review 1.  Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities.

Authors:  Jacques Galipeau; Luc Sensébé
Journal:  Cell Stem Cell       Date:  2018-06-01       Impact factor: 24.633

2.  The CECMED Office of Innovation: A Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach.

Authors:  Belkis Romeu; Rafael Perez Cristiá
Journal:  Ther Innov Regul Sci       Date:  2020-07-27       Impact factor: 1.778

Review 3.  Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan.

Authors:  Yasuko Inokuma
Journal:  Drug Saf       Date:  2017-06       Impact factor: 5.606

4.  One Size Fits All?: Ethical Considerations for Examining Efficacy in First-in-Human Pluripotent Stem Cell Studies.

Authors:  Michelle Gjl Habets; Johannes Jm van Delden; Sophie L Niemansburg; Harold L Atkins; Annelien L Bredenoord
Journal:  Mol Ther       Date:  2016-12       Impact factor: 11.454

5.  Tackling Ethical Challenges of Premature Delivery of Stem Cell-Based Therapies: ISSCR 2018 Annual Meeting Focus Session Report.

Authors:  Jeremy Sugarman; Roger A Barker; Ian Kerridge; Tamra Lysaght; Graziella Pellegrini; Douglas Sipp; Claire Tanner
Journal:  Stem Cell Reports       Date:  2018-11-13       Impact factor: 7.765

6.  Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications.

Authors:  Moses Fung; Yan Yuan; Harold Atkins; Qian Shi; Tania Bubela
Journal:  Stem Cell Reports       Date:  2017-04-13       Impact factor: 7.765

7.  Conditional Approval Pathways: The "Special" Case of Global Regenerative Medicine Regulation.

Authors:  James A Smith; David A Brindley
Journal:  Rejuvenation Res       Date:  2017-02       Impact factor: 4.663

8.  Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

Authors:  Yoji Jokura; Kazuo Yano; Masayuki Yamato
Journal:  J Tissue Eng Regen Med       Date:  2017-06-27       Impact factor: 3.963

Review 9.  A blueprint for the next generation of ELSI research, training, and outreach in regenerative medicine.

Authors:  Judy Illes; Douglas Sipp; Erika Kleiderman; Shelly Benjaminy; Rosario Isasi; Geoff Lomax; Zubin Master; Jennifer McCormick; Ubaka Ogbogu; Vardit Ravitsky; Julie M Robillard; Fabio Rossi; Brenda Wilson; Amy Zarzeczny
Journal:  NPJ Regen Med       Date:  2017-07-05

10.  Current and emerging global themes in the bioethics of regenerative medicine: the tangled web of stem cell translation.

Authors:  Sarah Chan
Journal:  Regen Med       Date:  2017-11-09       Impact factor: 3.806
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