2025/03/19
Notice
March 19, 2025, the Japanese Society for Regenerative Medicine (JSRM) announced the adoption of the “YOKOHAMA Declaration 2025” during its 24th Annual Meeting, held in Yokohama, Japan.
As regenerative medicine, whose efficacy and safety have not been fully verified, spreads internationally, YOKOHAMA Declaration 2025 distinguishes between two categories to provide patients with medical care based on rigorous and sufficient scientific evidence:
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Explorative Therapy： Therapy using processed cells or nucleic acids, etc., for which a manufacturing and marketing approval has not been obtained under the PMD Act, and for which clinical data are accumulated in an independent third-party registry, and an Explorative Study is conducted both before and following the treatment.
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Uninvestigated Therapy： Therapy not qualified as “Explorative Therapies,” by using processed cells or nucleic acids, for which a manufacturing and marketing approval has not been obtained under the PMD Act.
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For more information, please check this page of JSRM.
Our cluster will work to realize “exploratory therapy.”
