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About Regulating Authority

National Institute of Health is the authority in charge of enforcing the Clinical Trials Regulation in Peru nationwide; approved by Supreme Decree No. 017-2006-SA and norms related regulating the authorization and conduction of clinical trials. Besides, it is in charge of enacting the complementary provisions required for the enforcement of such norms. Such role is executed by means of the General Offi ce for Research and Technology Transfer – OGITT, which is in charge of authorizing the clinical trials, under the conditions and requirements set forth by regulations; the research product surveillance and safety and the Supervision of Clinical Trials, in order to safeguard the rights, welfare and integrity of research subjects, as well as to protect their intimacy and information, by promoting ethical and quality practices in processes and by disseminating the results derived from them.

Likewise, OGITT is the authority in charge of the Peruvian Clinical Trials Registry - REPEC, which includes information about clinical trials registered nationwide, and which is permanently updated.

To know more about OGITT, visit http://www.portal.ins.gob.pe/es/.