The ideal way to design clinical trials and establishment of evidence for human cellular and tissue‐based products in Japan

Author:

Sawa Yoshiki1ORCID

Affiliation:

1. Division of Cardiovascular Surgery, Department of SurgeryOsaka University Graduate School of Medicine Suita Japan

Publisher

Wiley

Subject

Biomedical Engineering,Biomaterials,Medicine (miscellaneous)

Reference14 articles.

1. Recent policies that support clinical application of induced pluripotent stem cell‐based regenerative therapies;Azuma K.;Regenerative Therapy.,2016

2. European Medicines Agency (EMA). (20 October2017).European Commission‐DG Health and Food Safety and European Medicines Agency Action Plan on ATMPs. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/10/WC500237029.pdf(accessed 25 December 2018)

3. Government of Japan. (10 May2013a).Act for the Promotion of Regenerative Medicine [in Japanese] Act No. 13 of May 10.2013. Available at:https://www.mhlw.go.jp/file/06‐Seisakujouhou‐10800000‐Iseikyoku/0000150835.pdf(accessed 25 December 2018)

4. Government of Japan. (27 November 2013b).Pharmaceuticals and Medical Devices Act [in Japanese] Act No. 103 of Nov. 2013”. Available at:https://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/dl/140825_0‐1.pdf(accessed 25 December 2018)

5. Skeletal myoblast transplantation in ischemic heart failure: long‐term follow‐up of the first phase I cohort of patients;Hagège A. A.;Circulation,2006

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