New Regulations Affecting Clinical Trials in Peru
On June 30, 2017, Peru's Ministry of Health (MINSA) issued a new regulation that reinstates clinical studies for the pediatric population and native communities.
In 2015, MINSA suspended the issuance of authorizations for the development of clinical trials involving pediatric population and native communities in order to update the requirements for these groups. For the past two years, MINSA has been working on the new regulation that would involve better qualifications of the research projects at a national level and protect the rights, dignity and well-being of people enrolled in the studies.
The regulatory committee of the Peruvian Contract Research Organizations Association (APOICC) will be analyzing the new regulation to provide recommendations to be included in the revised INS SOP, for approving clinical trials, that will accompany this supreme decree, which is now effective.
You can view the complete regulation in this site: http://busquedas.elperuano.com.pe/download/url/aprueban-reglamento-de-ensayos-clinicos-decreto-supremo-n-021-2017-sa-1538902-2