The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.
The review reports were selected for translation among those of new regenerative medical products that recently received marketing approval, in consideration of relevant factors including the novelty and priority.
EN, English; JP, Japanese
|Brand Name||Generic Name||Approved In||PDF
|HeartSheet||human (autologous) skeletal myoblast-derived cell sheet||September 2015|
|JACC||human autologous tissue for transplantation||July 2012|
|human (autologous) epidermal cell sheet||October 2007|
Partial Change Approval
|human (autologous) epidermal cell sheet||September 2016|
|Stemirac||human (autologous) bone marrow-derived mesenchymal stem cells||December 2018|
|Temcell||human (allogeneic) bone marrow-derived mesenchymal stem cells||September 2015|
* This product was approved as a medical device under the previous regulatory framework.