Bills passed on regenerative meds


The Upper House passed a bill Wednesday aimed at ensuring the safety of regenerative medicine and another to revise the pharmaceutical affairs law to promote safe and swift treatment using induced pluripotent stem (iPS) cells and other stem cells.

The bills had already cleared the Lower House and so now are law.

The new safety law demands medical institutions submit regenerative medicine plans to the health ministry before implementing them. The institutions would be ordered to stop treatment and penalized if they fail to submit or falsify plans.

The revised pharmaceutical affairs law defines medical products containing stem cells as regenerative medicine products. It allows the government to approve such products conditionally even when their effects are not verified, if their safety is confirmed in clinical trials.