Ethical governance and biosafety management in the national and international regulation of biomedical products

Abstract

Introduction: the sanitary regulation of medicines and vaccines has evolved in response to technological and social challenges that demand more participatory institutional frameworks and stronger ethical values. In this context, biosecurity is recognized as a structural dimension indispensable for the ethical legitimacy of regulatory decisions.

Objective: to analyze, from an ethical perspective, the incorporation of biosecurity principles into the regulation of biomedical products, considering their phases, ethical-institutional categories, and normative models in national and international agencies.

Methods: a critical integrative review of thirty-nine academic and normative sources published between two thousand fifteen and two thousand twenty-five was conducted, using thematic coding, comparative analysis, and critical systematization. Geographic, institutional, and conceptual diversity was ensured, applying a qualitative analytical approach consistent with defined methodological standards.

Development: the analysis was structured into three thematic blocks: ethical articulation of the regulatory process, structuring categories of biosanitary governance, and comparative models of regulatory frameworks. Visual resources with argumentative function were incorporated, and technical-administrative approaches were contrasted with ethical-biosecure models, highlighting legitimizing practices that guide regulatory improvement processes.

Conclusions: the systematic integration of biosecurity and institutional ethics strengthens the biosanitary regulatory framework and provides legitimacy to regulatory decisions. The Center for State Control of Medicines, Equipment, and Medical Devices is positioned as a regional reference, with robust normative capacity and potential for expansion through intersectoral articulation, social participation, and sustainable approaches. This framework contributes to the strengthening of more solid and ethically grounded regulatory structures, increasing their legitimacy, traceability, and conceptual clarity in governance practices.