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Stem-cell laws in Japan 2013

Author
Master
Date
2013-11-20 12:20
Views
27782

Japan passed two regenerative-medicine laws on 20 November.
A law intended to hasten approval of stem-cell treatments rules that candidate therapies no longer need to pass rigorous phase III clinical trials to prove efficacy — a move that critics say could flood the market with ineffective treatments (see Nature Med. 19, 510; 2013). Another law requires physicians to report the clinical use of unapproved stem-cell therapies to the Japanese health ministry.
The new regulations will be implemented within a year.



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