Principles of Regulatory Trust: The Rules of Reliance Game 

La importancia de la confianza regulatoria en la industria farmacéutica no puede subestimarse. Con el avance de las tecnologías médicas y un entorno globalizado, la necesidad de un marco regulatorio eficaz y coherente es más crítica que nunca. La Organización Panamericana de la Salud (OPS) ha propuesto una serie de principios fundamentales para la utilización de decisiones regulatorias de otras jurisdicciones, conocidos como “regulatory“. 

These principles not only aim to optimize the resources and capabilities of national regulatory agencies (NRAs) but also to ensure the safety, efficacy, and quality of medical products. Below, we explore each of these principles and their potential impact on Latin America and the Caribbean.

Universality: This principle establishes that the regulatory approach should be applied to all national regulatory agencies, regardless of their level of maturity or resources. This is especially relevant for regions with limited resources, where adopting regulatory decisions from jurisdictions with more advanced systems can accelerate access to innovative treatments without compromising safety.

Sovereignty: Despite international collaboration, each national regulatory agency maintains its independence and must be accountable for the decisions it makes. This principle ensures that decisions are made with total transparency and based on local interests and regulations, which is crucial for maintaining public trust in healthcare systems.

Transparency: National regulatory agencies must be clear and open about how they implement regulatory, including the standards, processes, and criteria used. Transparency not only facilitates the harmonization of regulatory standards but also promotes greater trust among stakeholders and consumers.

Legal Basis: This principle emphasizes the need for regulatory practices to be grounded and aligned with national legal frameworks and policies. It ensures that imported regulatory decisions do not conflict with local laws and that existing rights and obligations within each country are respected.

Uniformity The uniform application of regulatory criteria to all relevant products and processes ensures that there is no discrimination or undue preferences. This is essential for manufacturers and other sector players to have clarity and certainty about the requirements to be met.

Competence: Finally, the principle of competence highlights the need for NRAs to possess the skills and knowledge necessary to evaluate and adopt critical regulatory decisions. This involves a constant commitment to training and professional development of regulatory personnel.

Together, these principles not only reinforce the integrity and effectiveness of regulatory systems in Latin America and the Caribbean but also promote greater international cooperation. By adopting a regulatory‎ approach, NRAs can significantly improve access to safe and effective medicines while optimizing their resources and adapting to a dynamic global environment.

Source: Pombo, M. L. (2022). Principios para una efectiva utilización de decisiones de autoridades regulatorias de otras jurisdicciones [Principles of an effective regulatory reliance]. Webinario “Posibilitando la utilización de otras autoridades regulatorias en las Américas”. Unidad de Medicamentos y Tecnologías Sanitarias, OPS/OMS.