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.
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to CytotherapyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
