Answer： Interim Measures, similar to many other Chinese regulations, was written in a very broad and vague fashion, and if read plainly, could apply to all activities involving human biological samples.  In practice, from 1998 through 2011, China Human Genetic Resource Administration Office (CHGRAO) only imposed approval requirement in situations where the human genetic resources (“HGR”) would be exported from China.  Starting from 2011 to recently, CHGRAO extended the approval requirement (through oral consultation) to situations where HGRs would be collected and retained.  In the context of clinical studies, if HGRs were to be discarded after the collection, no approval from CHGRAO would be required.  During our recent oral consultation, however, CHGRAO has taken a more stringent position.  It suggested that all Sino-Foreign collaborations involving HGRs would require its approval.  The notice issued by the Ministry of Science and Technology (“MOST”) supervising CHGRAO in October 2013 reinforced the need for approval, without clarifying a number key concepts (i.e., Sino-Foreign collaboration, as well as whether research on genetic information is a prerequisite). On 2 Jul 2015, the Ministry of Science and Technology (“MOST”) released the Guideline on Human Genetic Resource Collection, Trade and Exportation Admission and Approval, which will be effective on 1 October 2015. The link is attached here for reference. http://www.most.gov.cn/tztg/201507/t20150703_120547.htm