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Japan: Govt. to Legislate Cell Therapy Guidelines
Source: yomiuri.co.jp
Source Date: Sunday, December 16, 2012
Focus: Institution and HR Management
Country: Japan
Created: Dec 17, 2012

A special committee of the Health, Labor and Welfare Ministry announced on Friday plans to legislate safety rules for cell therapy, such as regenerative medicine using induced pluripotent stem cells.

The ministry hopes to introduce a relevant bill in next year's ordinary Diet session.

Under existing guidelines, clinical studies on regenerative medicine conducted at universities and other public institutions need to obtain approval in advance from the health minister.

But the ministry does not regulate cell therapy conducted at private clinics

The legislation is expected to make prior approval mandatory, depending on the risks of treatment using iPS and other cells, and stipulate cell-culture guidelines.
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