PERÚ:  There are new clínical trial regulations. Ban on pediatric trials was lifted.

July 6, 2017

On 30-JUN-2017, after two years, the Peruvian Ministry of Health has issued a new clinical trial regulation (Supreme Decree Nr. 021-2017-SA) that replaces the previous regulation from 2006 and repeals Supreme Decree Nr. 020-2015-SA that had set a moratorium on clinical studies in the pediatric population and native communities.  Under the new regulation pediatric trial can be submitted and approved in Peru again.

 

For further detail please review the post published at the Peruvian CRO association (APOICC) in Spanish here.

 

 

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