Observatorio Regional FIFARMA

La activación de escenarios de transferencia tecnológica a nivel global se visualiza como un
camino estratégico para impactar positivamente el desarrollo y el fortalecimiento de
capacidades y escenarios para la producción farmacéutica, a través del relacionamiento
colaborativo.

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El presente documento brinda una síntesis del análisis de los resultados de la evaluación de los requerimientos y prácticas de aceptación, uso y emisión del Certificado de Producto Farmacéutico
(CPF) como documento clave en los procesos regulatorios de registro de medicamentos
en la región de las Américas, y de la base legal que sustenta su uso.

This document presents a summary of the analysis of the results for the assessment of the
requirements and practices for the acceptance, use and issuance of the Certificate of Pharmaceutical
Product (CPP) as a key document in the regulatory processes of medicine registration in the
region of the Americas, and in the legal basis supporting its use.

El presente documento brinda una síntesis del análisis de los resultados de la evaluación de los
requerimientos y prácticas de aceptación, uso y emisión del Certificado de Producto Farmacéutico
(CPF) como documento clave en los procesos regulatorios de registro de medicamentos en la región
de las Américas, y de la base legal que sustenta su uso.

This document presents a summary of the analysis of the results for the assessment of the
requirements and practices for the acceptance, use and issuance of the Certificate of Pharmaceutical
Product (CPP) as a key document in the regulatory processes of medicine registration in the region
of the Americas, and in the legal basis supporting its use.

Post-approval changes (PAC) for medicinal products have increased rapidly in recent years, and faster than national regulatory authorities (NRAs) can reliably cope with. This is both a concern and a challenge for Latin American countries. The World Health Organization (WHO) has recently published two documents that will be critical for countries’ regulatory system strengthening activities, including regulatory cooperation, convergence and transparency.

IFPMA Code of Practice 2019 Q&A on the 2019 Code update

Una iniciativa regional multisectorial para la industria farmacéutica en América Latina, encabezada por Transparencia Internacional, Capítulo Reino Unido (TI-UK), a través del Programa global del sector biofarmacéutico y servicios para la salud.

The IFPMA Code of Practice was first drawn up in 1981, and it was the first one of its kind for any sector. The 2019 version  is marked by two important changes: First, several sections have been updated, including the introduction of a ban on gifts and promotional aids (for Rx based medicines) and secondly there has been a shift from a rules-based to a values-based Code.

Es una iniciativa regional multisectorial de la industria farmacéutica en América Latina, encabezada por Transparencia Internacional UK. Este documento ha sido diseñado para proporcionar a las empresas farmacéuticas una guía práctica y un punto de referencia en el desarrollo de políticas y procedimientos propios para promover la integridad en sus actividades.

A regional multi-stakeholder initiative for Latin America’s pharmaceutical industry led by Transparency International’s Pharmaceuticals and Healthcare Programme. This document has been designed to provide companies with practical guidance and a reference point for developing their own policies and procedures for promoting integrity.

A Regional Multi-stakeholder Initiative for Latin America led by Transparency International UK’s Pharmaceuticals & Healthcare Programme.

Attainment of universal health coverage (UHC) has become a priority for Latin America (LA) governments, but increasing coverage unavoidably comes with rising healthcare costs and the challenge of fostering efficiencies.

Latin America was among the regions hit hardest by the COVID-19 pandemic in terms of health and the economy. As every disruption has potential for societal progress, this report provides insights into the status of theHealthEconomies and on health sector reforms in selected Latin American (LatAm) countries. These exemplary cases can serve as an evidence base to support and guide policy work on further enhancing resilience in the transition to the post-COVID era. The report strengthens the view of health as an investment rather than a cost for society, which pays off in the future and offers a considerable return on investment for society as a whole.

El logro de la cobertura universal de salud (CUS) se ha convertido en una prioridad para los gobiernos de América Latina (AL), pero aumentar la cobertura inevitablemente conlleva el aumento de los costos de salud y el desafío para fomentar la eficiencia.