
Washington, D.C., Feb. 3, 2025 (PAHO)-The Ministry of Public Health of Ecuador presented the new “Regulations of Clinical Trials with Medicines and Processed Natural Products for Medicinal Use for Human Use,” which was developed with the technical cooperation of the Regional Program on Bioethics of the Science and Knowledge for Impact Unit of PAHO's Department of Evidence and Intelligence for Health Action (EIH/SK), and of the Quality and Regulation of Medicines and Health Technologies Unit of PAHO's Department of Innovation, Access to Medicines and Health Technologies (IMT/QR).
The new regulation establishes specific guidelines for the approval, authorization, execution, oversight, and control of clinical trials seeking regulatory authorization in Ecuador in accordance with the highest international ethical and regulatory standards. In the academic activity that was part of the event, Dr. Carla Saenz, regional Bioethics advisor (EIH/SK), and Dr. Patricia Saidón, responsible for clinical trials (IMT/QR), highlighted the importance of the new regulation for the conduct of rigorous, transparent and impactful trials on the health and welfare of populations.
“The coordinated support of EIH/SK and IMT/QR has led Ecuador to achieve several indicators of national research ethics systems. Moreover, this coordinated support continues because, for the successful implementation of the new regulation, both PAHO teams have initiated training programs on ethical and regulatory aspects, respectively,” Saenz said.
This important achievement of Ecuador is already reflected in the regional assessment of research ethics systems available on the Portal of Clinical Trials of the Americas, a platform that EIH/SK launched at the end of 2024 to strengthen scientifically and ethically sound clinical trials in the region and to make visible the joint efforts with Member States, as part of the implementation of WHO resolution WHA75.8.