Regulatory approach and analysis of clinical pharmacology studies by the National Administration of Medicines, Food and Medical Devices during the COVID-19 pandemic

Abstract

The Department of Clinical Trials of the Directorate of Evaluation and Registration of Medicines of the National Administration of Medicines, Food and Medical Devices (ANMAT) carries out the inspection and evaluation activities of clinical pharmacology studies within the scope of application of ANMAT Provision 6677/10. The pandemic declared by the World Health Organization due to the SARS-COV-2 virus forced the regulatory agencies around the world to quickly adapt in order to be able to propose measures and offer responses at the speed that the health emergency required. On the one hand, the understanding of both epidemiology and clinical spectrum of coronavirus disease has evolved, and the knowledge of the disease burden stressed the medical need to urgently develop vaccines and drugs as a prevention and treatment strategies for this pathology. This situation caused clinical pharmacology research to acquire a leading role in the search for answers to this disease, scientifically sound and in the shortest possible time. On the other hand, the quality of clinical research activities being carried out had to be preserved, ensuring the safety and welfare of the study participants, and also, avoiding viral dissemination and saturation of the health system. As a result, the purpose of this work is to make a description of the measures adopted in the pandemic by the Department of Clinical Trials of ANMAT, and to analyse the clinical pharmacology studies on COVID-19 received and authorized by ANMAT from May 1, 2020 to August 3, 2021.