Some 10 years since Japan introduced policies, regulations and review pathways to encourage the development and commercialization of cell therapy products, the country has recently modified some regulations in the field to take account of an admitted “lack of predictability” for some products.
Progress Or Hype? A Decade Of Cell Therapy In Japan
Mixed Commercial Success
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.
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