Impacto da resolução RDC 786/2023 da ANVISA em serviços farmacêuticos

Abstract

The work analyzed the impact of ANVISA Resolution RDC 786/2023 in the health area, which replaces RDC ANVISA 302/2005, with regard to clinical laboratory services, pathological anatomy and others related to clinical analysis exams (EACs ). The objective of the work was to investigate the positioning and impacts of RDC 786/2023 on various institutions and professionals in the health sector, considering their perspectives and contributions to understanding the regulation and its practical implications. A narrative review was carried out that included analysis of the positioning of different institutions, such as ANVISA, SBAC, SBPC-ML, ABRAMED, CRF-SP and CRF-MT. Publications, technical notes, workshops, podcasts and other relevant sources were considered to understand the impact and interpretation of RDC 786/2023. The results highlighted different perspectives in relation to RDC 786/2023. Some institutions expressed support for the resolution, recognizing its benefits for the quality and safety of health services. Others raised concerns about the technical, health and practical aspects of implementing the regulation, highlighting challenges and areas that need improvement. Given the analysis of the positioning of different institutions and professionals, it is concluded that RDC 786/2023 represents a significant advance in the regulation of clinical laboratory services. The complexity of the clinical analysis scenario requires a continuous effort of dialogue and collaboration between the various actors involved, from regulatory entities to health professionals and laboratory service managers.