Comparative Analysis of the Regulation for Emergency Use Authorization of Drugs and Vaccines in Brazil and in the World

Abstract

The development of drugs and vaccine and the analysis of information on the safety and efficacy of new products, which precedes their availability for use, requires considerable time. When a health emergency arises and in which there are no effective medicines and vaccines, the delay can have a high cost in suffering and lives. Emergency Use Authorization is a regulatory alternative designed to balance the tension between the speed required by the health emergency and the time needed to thoroughly evaluate the safety and efficacy of new products to contain the threat to public health. The main regulatory agencies in the world have their own guidelines. This article aimed to compare the guidelines of regulatory agencies in Brazil, China, United States and the European Union with those of the World Health Organization. To this end, a systematic search for existing standards on the subject on the official websites of each agency was carried out. Eligibility for granting Emergency Use Authorization, regardless of the agency analyzed, requires the declaration of a health emergency; that there are no effective, safe or satisfactory licensed products to address it; that the information on the safety and efficacy of the product under development, although incomplete, indicates a clearly favorable risk-benefit ratio; and that the product has satisfactory quality. In contrast to what happened with other agencies, the Covid-19 pandemic surprised the Brazilian Health Regulatory Agency, which had no provision for granting Emergency Use Authorization, and it was necessary to prepare transitional rules, with the pandemic underway. Health emergencies will recur, and the comparative study of national and international standards proves to be a contribution to the improvement of the Brazilian regulation with a view to facing future health emergencies.