Abstract| Volume 18, ISSUE 6, SUPPLEMENT , S10-S11, June 2016

Accelerated Pathways for Cell Therapies in Japan: An Experiment in Ethics and Regulation

      In 2014, the Japanese National Diet introduced sweeping new laws aimed at promoting the clinical translation of stem cells and regenerative medicine. The basic action of these laws is to allow the early introduction of stem cell and cell-based products into the Japanese market before they have been demonstrated in formal clinical trials as safe and effective. Through an accelerated pathway that provides conditional approvals, commercial sponsors will be granted time limited licenses to market these products while efficacy trial data is gathered. Conditionally-approved products will also be eligible for either partial or full subsidization under the National Health Insurance Scheme. At the same time, medical institutions will be allowed to conduct early-phase clinical research with stem cells and offer them to patients in private clinical practice. Many in the scientific, clinical, bioethical, and regulatory communities are considering this framework as an experiment that aims to provide patients with patient's early access to highly novel cell therapies, but also raises many ethical and regulatory issues that have not yet been fully explored.
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