La OPS reúne a las autoridades regulatorias de las Américas para fortalecer el acceso a tecnologías de salud y la autosuficiencia sanitaria – OPS/OMS

Washington, DC, December 11, 2024 (PAHO) – The Pan American Health Organization (PAHO) meets for the second time this year the eight national regional reference regulatory authorities (rRNA) of the Americas, in order to strengthen health regulation and improve access to essential technologies. The meeting, held December 9-11 in Washington, DC, was co-hosted with the US Food and Drug Administration (FDA).

The event also brought together representatives of once national regulatory authorities as observers. This forum – which takes place twice a year – offers an opportunity for countries in the Americas to collaborate to improve their regulatory systems and promote equitable access to quality, safe and effective health products.

Lessons from the pandemic and the path to health self-sufficiency

Dr. Jarbas Barbosa, Director of PAHO, chaired a roundtable in which he highlighted the lessons learned from the COVID-19 pandemic, in particular the opportunities that exist to strengthen regulatory systems and guarantee access to health technologies that respond to regional health priorities. “These meetings allow us to transform individual achievements into collective advances for all the countries of the Americas,” said Dr. Barbosa.

The PAHO Director also highlighted the “fundamental role that regulatory strengthening and harmonization play in reducing barriers to accessing essential health technologies.” In addition, he emphasized the relevance of mechanisms such as Regional Revolving Funds and the WHO global tool for the evaluation of national regulatory systems for medical products (GBTfor its acronym in English) to improve public confidence in regulatory systems, identify gaps and draw roadmaps for strengthening regulation.

A call for health self-sufficiency

The meeting also addressed a critical issue for the region: health self-sufficiency. The rRNAs and NRAs agreed that the relationship between development and regulation is essential to advance self-sufficiency. The COVID-19 pandemic revealed the fragility of health systems and supply chains in the face of a global crisis and the need to have robust mechanisms to promote innovation and regional production, guaranteeing the quality, availability and accessibility of health technologies. . .

“It is essential that we work together to promote a coordinated and collaborative approach between countries, which will allow all inhabitants of the Americas to have access to health technologies,” said Judit Rius Sanjuan, director of the Department of Innovation, Access to Medicines and PAHO Health Technologies (IMT). Rius Sanjuan highlighted PAHO’s commitment to continue strengthening and adapting technical cooperation with regulatory authorities to advance access and promotion of regional innovation and production.

During the meeting, a proposal for a new rRNA designation system was discussed, as well as the performance of regulatory authorities in relation to evaluation based on GBT. The rRNAs also discussed their annual work plan and the priorities to follow in the area of ​​regulatory strengthening.

The coordination of the rRNA group, which is currently held by the United States FDA, will be assumed in 2025 by the Institute of Public Health of Chile (ISP).

Members of the eight national reference regulatory authorities (RNAr) participated in the meeting: the National Administration of Medicines, Food and Medical Technology (ANMAT) of Argentina; the National Health Surveillance Agency (ANVISA) of Brazil; Health Canada of Canada; the National Institute for Food and Drug Surveillance (INVIMA) of Colombia; the Center for State Control of Medicines, Equipment and Medical Devices (CECMED) of Cuba; the Institute of Public Health (ISP) of Chile; the United States Food and Drug Administration (FDA); and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) of Mexico.

Representatives of 11 national regulatory authorities participated as observers: BDS of Barbados, MS of Costa Rica, ARCSA of Ecuador, SRS of El Salvador, MSPAS of Guatemala, ARSA of Honduras, DINAVISA of Paraguay, DIGEMID of Peru, DIGEMAPS of the Dominican Republic and MSP of Uruguay, as well as the Caribbean Public Health Agency (CARPHA).