Ministry OKs iPS approval system


A health ministry panel has proposed requiring medical institutions to undergo a two-stage approval system for stem cell treatments.

Under current ministry guidelines, medical institutions are requested, but not required, to get advance approval from the health minister for clinical applications of both induced pluripotent and embryonic stem cells.

The panel is now recommending making approval mandatory. It also wants to oblige medical institutions to form judging committees with third-party members to screen their methods before proceeding with treatments involving other types of stem cells as well.

Based on those proposals, the ministry plans to craft a bill stipulating rules to ensure the safety of regenerative medicine at the clinical stages and introduce the legislation to the Diet.

Under the ministry’s current nonbinding guidelines, the ministry cannot stop private clinics from conducting clinical applications of iPS, ES and other stem cells at will. The bill would stipulate penalties for those who carry out stem cell treatment without third-party screening or ministerial approval, officials said.