Regulatory Focus™ > News Articles > China Proposes Stem Cell Clinical Trial Rules

China Proposes Stem Cell Clinical Trial Rules

Posted 08 March 2013 | By Louise ZornozaRegLink

China's Ministry of Health and the State Food and Drug Administration (SFDA) have proposed draft regulations governing stem cell clinical trial management and the quality control of stem cell preparations and pre-clinical research.

All proposed clinical trials on stem cells would be subject to prior review by ethics committees, and sponsors would be required to submit informed consent forms, safety evaluation and research protocols as well as information concerning the qualifications of the principal investigators. 

Sponsors would also have to submit information concerning the production of the investigational stem cell products.  Moreover, only hospitals certified by the SFDA would be allowed to be sites for such trials. Also according to the rules, during the first three phases of stem cell clinical experiments, test subjects should not be charged. Medical institutions that violate the rules will lose their qualification and face penalties.


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