ダウンロード数: 208
このアイテムのファイル:
ファイル | 記述 | サイズ | フォーマット | |
---|---|---|---|---|
j.reth.2016.01.009.pdf | 505.1 kB | Adobe PDF | 見る/開く |
タイトル: | Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies |
著者: | Azuma, Kentaro Yamanaka, Shinya |
著者名の別形: | 東, 健太郎 山中, 伸弥 |
キーワード: | Regenerative medicine Policy Regulation iPS cells Haplobank Japan |
発行日: | Jun-2016 |
出版者: | Elsevier BV |
誌名: | Regenerative Therapy |
巻: | 4 |
開始ページ: | 36 |
終了ページ: | 47 |
抄録: | In Japan, a research center network consisting of Kyoto University to provide clinical-grade induced Pluripotent Stem Cells (iPSC) and several major research centers to develop iPSC-based regenerative therapies was formed for the clinical application of iPSCs. This network is under the supervision of a newly formed funding agency, the Japan Agency for Medical Research and Development. In parallel, regulatory authorities of Japan, including the Ministry of Health, Labour and Welfare, and Pharmaceuticals and Medical Devices Agency, are trying to accelerate the development process of regenerative medicine products (RMPs) by several initiatives: 1) introduction of a conditional and time-limited approval scheme only applicable to RMPs under the revised Pharmaceuticals and Medical Devices Act, 2) expansion of a consultation program at the early stage of development, 3) establishment of guidelines to support efficient development and review and 4) enhancement of post-market safety measures such as introduction of patient registries and setting user requirements with cooperation from relevant academic societies and experts. Ultimately, the establishment of a global network among iPSC banks that derives clinical-grade iPSCs from human leukocyte antigens homozygous donors has been proposed. In order to share clinical-grade iPSCs globally and to facilitate global development of iPSC-based RMPs, it will be necessary to promote regulatory harmonization and to establish common standards related to iPSCs and differentiated cells based on scientific evidence. |
著作権等: | © 2016, The Japanese Society for Regenerative Medicine. Production and hosting by Elsevier B.V. his is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/). |
URI: | http://hdl.handle.net/2433/242857 |
DOI(出版社版): | 10.1016/j.reth.2016.01.009 |
PubMed ID: | 31245486 |
出現コレクション: | 学術雑誌掲載論文等 |
このリポジトリに保管されているアイテムはすべて著作権により保護されています。