PEDIATRIC FORMULATIONS IN BRAZIL: CHALLENGES, PERSPECTIVES AND EXISTING LEGISLATION – A NARRATIVE REVIEW

Abstract

This study aimed to map and analyze the national scenario regarding the production, regulation, and use of pediatric formulations in Brazil, highlighting challenges, gaps, and perspectives. It is a narrative literature review with a qualitative analysis of official documents, scientific articles, and specialized publications selected for their relevance to the topic. The results showed that, although there is a regulatory framework for food and medicinal formulations, it is fragmented and not sufficiently specific to meet pediatric needs. Recurrent concerns were identified regarding the safety of excipients and solvents, the absence of clear guidelines for suitable pharmaceutical forms, and the limited diversity of available products. The relevance of compounding practices was also noted as an alternative for access, although accompanied by risks related to variability in quality and standardization. Complex regulatory aspects, production costs, and technical barriers were found to be additional obstacles to the development of new formulations. It is concluded that the implementation of specific guidelines, the encouragement of clinical research in pediatrics, and cooperation among regulatory agencies, industry, and academia are essential to drive progress. Strengthening public policies in this field is crucial to expanding access to safe, effective, and equitable pediatric medicines and foods.