The National Health and Family Planning Commission (the “NHFPC”) and the China Food and Drug Administration (the “CFDA”) recently jointly published the Administration Measures for the Research (for Trial Implementation) (the “Administration Measures”), which became effective on 20 July 2015.
The Administration Measures state that the Research (the “Research”) must comply with the principles of science, standardization, openness, ethics, and sufficient protection of the rights of research subjects. The Administration Measures also stipulate the qualifications and duties of the Research institutions, the review and record filing mechanism of the Research projects, the regulatory measures for the Research, and the protection of the rights of the Research subjects. Meanwhile, upon the promulgation of the Administration Measures, technologies related to stem cell treatment will no longer be regulated as class III medical technologies. It is worth noticing that Research accomplished under the Administration Measures cannot directly enter into clinical application.
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