[Role of the state as regulatory authority of clinical trials in Peru]. / Rol del estado como autoridad reguladora de ensayos clínicos en el Perú

ABSTRACT

This article sheds the light on historical review of the clinical trials regulatory process to the publication of the Clinical Trials Regulation in Peru, by Supreme Decree 017-2006-SA. In this context, that Regulation was amended within one year, with many critics including from the Ombudsman. It also considers the achievements as a regulatory authority that has strengthened its steering and its main objective of protecting the rights, safety and welfare of human subjects in clinical trials. Those achievements are the internal register of clinical trials, strengthening inspections on all stakeholders that take part in research, the Notification System of Serious Adverse Events (REAS-NET), the publication of the Guideline "Ethical, Legal and methodology in clinical trials for use of the Ethical Review Board" which won an international award; the 1st prize in the category of fizcalization and accomplishment of the law by the Good Practice of Public Management "Protecting the rights of human subjects in experimental studies", the publication of the new Manual of Procedures for Clinical Trials and the implementation Plan of the National Bioethics Network in Peru.