China Drafts New Rules For Clinical Trials Of Stem-Cell Treatments
This article was originally published in PharmAsia News
Executive Summary
China has drafted new rules governing stem-cell clinical trials in an effort to afford greater protection for the providers as well as the participants.
China has drafted new rules governing stem-cell clinical trials in an effort to afford greater protection for the providers as well as the participants. The Ministry of Health and the State FDA put the proposed changes out for public responses. The changes would make all such experiments subject to ethical review, researchers would have to supply relevant materials, selection criteria, safety evaluation reports, research plans and other information, and providers and test participants would have to sign detailed consent forms. Trials also would be limited to top-level hospitals certified by the SFDA. (Click here for more
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"China To Further Regulate Stem Cell Clinical Experiments" - Xinhua (China) (3/7/2013)