Does the Act on the Safety of Regenerative Medicine in Japan ensure “safety”?: Implications of low adverse event reporting
Tsunakuni Ikka, Taichi Hatta, Yoko Saito, Misao Fujita · 2023
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Description
Tsunakuni Ikka and co-authors question whether Japan's regenerative medicine law delivers the safety its name promises in this 2023 paper. The law governs therapies like stem cell treatments given outside standard drug approval. The authors analyzed public documents on harm reporting under that law.
Harm events reported for treatments under the regenerative act were far fewer than those under the regular drug and device law. The gap, they argue, does not mean the therapies are safer. It points to weak reporting machinery that misses events. A law written with safety at its center is not meeting its own intent, the authors conclude, and the reporting system needs repair.
Catalog record
| CREATOR | Tsunakuni Ikka, Taichi Hatta, Yoko Saito, Misao Fujita |
|---|---|
| YEAR | 2023 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 10 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |