China to Further Regulate Stem Cell Clinical Experiments

Mar 08, 2013     Email"> PrintText Size

China will further regulate stem cell clinical experiments to protect the interests of providers and testees, according to draft rules by medical watchdogs.

The Ministry of Health (MOH) and the State Food and Drug Administration (SFDA) jointly publicized the draft rules on Thursday to solicit public opinions.

All clinical experiments on stem cells are subject to ethical review, said the the regulations.

Researchers must submit relevant materials surrounding stem cell products, selection criteria and detailed consent forms of providers and testees, safety evaluation reports, research plans, and resumes of main participating researchers to the ethical board for review.

Only top-level hospitals certified by the SFDA as eligible for carrying out drug clinical tests can apply to be stem cell clinical experiment bases.

Also according to the rules, during the first three phases of stem cell clinical experiments, testees should not be charged. Medical institutions that violate the rules will lose their qualification and face penalties. (Xinhua)