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OPS y autoridades regulatorias de referencia regional buscan superar brechas para fortalecer la regulación de productos médicos en las Américas

July 12, 2023
in Health
OPS y autoridades regulatorias de referencia regional buscan superar brechas para fortalecer la regulación de productos médicos en las Américas
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Washington, DC, 11 de julio de 2023 (OPS/OMS)- Contar con un plan de acción conjunto para abordar las brechas en el fortalecimiento de los sistemas regulatorios de tecnologías, medicamentos y vacunas en las Américas es uno de los objetivos primordiales de la 11ª Reunión de las autoridades regulatorias nacionales de referencia regional (ARNr) que se lleva a cabo esta semana en Washington, DC.

El Grupo de ARNr, presidido temporalmente por Brasil, también busca renovar sus compromisos en el contexto de la Política para el fortalecimiento de los sistemas regulatorios nacionales de medicamentos y otras tecnologías sanitarias (aprobada por la Conferencia Sanitaria Panamericana en setiembre de 2022).

Entre los principales temas que tratará el Grupo de ARNr, cuyo secretariado pertenece a la Organización Panamericana de la Salud (OPS/OMS), se destacan una hoja de ruta para la transición hacia autoridades listadas por la OMS (WLA, por sus siglas en inglés) y la presentación de iniciativas regionales para fortalecer las capacidades regulatorias de los recursos humanos.

El Director de la OPS, doctor Jarbas Barbosa, reafirmó su compromiso con el fortalecimiento de las capacidades regulatorias de los Estados Miembros. Además, resaltó el papel fundamental del Grupo de ARNr en la implementación de la nueva estrategia mundial de evaluación para un mayor nivel de madurez en los sistemas regulatorios de la región.

“A través de sistemas fortalecidos y eficientes, basados en buenas prácticas regulatorias, que promuevan la adopción de normas armonizadas y el uso de decisiones de otras jurisdicciones, podremos favorecer el acceso equitativo a tecnologías sanitarias seguras, eficaces y de calidad, tanto en situaciones de rutina como en emergencias de salud”, agregó el doctor Barbosa.

Por su parte, el presidente de la Agencia Nacional de Vigilancia Sanitaria (ANVISA) de Brasil, Antonio Barra, subrayó las diferencias de las capacidades regulatorias que se observan entre los países. “En este proceso, nosotros, como autoridades de referencia regional, tenemos una responsabilidad especial de coordinar nuestros esfuerzos y trabajar junto con la OPS en beneficio de toda la región”.

El Subdirector de la OPS, doctor Marcos Espinal, advirtió que, a pesar de los avances en la regulación regional en la última década, aún persisten brechas significativas en el fortalecimiento de las capacidades regulatorias. Remarcó que estas asimetrías se reflejan en las competencias del personal de salud y funciones regulatorias clave, como la vigilancia post mercado.

“La COVID-19 impactó las agendas y prioridades de los actores comprometidos con la promoción de la salud pública, incluyendo el Grupo de ARNr. Es hora de retomar y perfeccionar los esfuerzos postergados por la emergencia sanitaria, integrando las enseñanzas de la pandemia y las prioridades establecidas en las resoluciones aprobadas por los Estados Miembros de la OPS en los últimos años”, dijo el doctor Espinal.

El Grupo de ARNr se reúne cada dos años desde 2013 para fortalecer a las autoridades regulatorias nacionales de la región, cuya función central es promover y proteger la salud pública al supervisar la calidad, la seguridad y la eficacia de todas las tecnologías sanitarias presentes en el mercado, incluidos fármacos, vacunas, productos sanguíneos, dispositivos médicos.

Conforman el Grupo la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) de Argentina, la Agencia Nacional de Vigilancia Sanitaria (ANVISA) de Brasil, el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) de Colombia, el Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) de Cuba, el Instituto de Salud Pública (ISP) de Chile, la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) de México, Health Canadá y The Food and Drug Administration (FDA) de Estados Unidos.

La designación de estas autoridades, basada en una resolución del Consejo Directivo de la OPS de 2010, es un reconocimiento a las capacidades regulatorias en la región. Esta designación fomenta el intercambio de información sobre la regulación de medicamentos y otras tecnologías sanitarias entre los países, fortaleciendo así a otros entes regulatorios nacionales.

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Copyright for syndicated content belongs to the linked Source : WHO Americas – https://www.paho.org/es/noticias/11-7-2023-ops-autoridades-regulatorias-referencia-regional-buscan-superar-brechas-para

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