Washington, DC. - June 12, 2024 - The Pan American Health Organization (PAHO) hosted the Meeting of the National Regulatory Authorities of Regional Reference (NRAr) to discuss and analyze regulatory issues of interest, this time under the leadership of the FDA as the pro-tempore Chair of the NRAr Group. This meeting opens its doors to the participation as observers of other NRA in the Region, such as Costa Rica, Honduras, Ecuador and Paraguay to work for a healthier and more equitable Region.
The meeting aimed to review progress on commitments on strengthening regulatory systems for medicines and other health technologies, discuss roadmaps for the transition of the Authorities to WHO WLA status, as well as a new system for the designation of NRAs in the Americas.
The meeting was attended by the NRAr group made up of the following agencies: ANMAT of Argentina, ANVISA of Brazil, HC of Canada, ISP of Chile, INVIMA of Colombia, CECMED of Cuba, COFEPRIS of Mexico and U.S. FDA of the United States. And as observers: Ministry of Health of Costa Rica, ARCSA of Ecuador, ARSA of Honduras and DINAVISA of Paraguay.
The NRAr meet twice a year to discuss and analyze regulatory issues of general interest and establish an annual work plan to support the strengthening of other regulatory authorities in the region. The renewed commitment of this Group of Authorities to the PANDRH Network will surely improve the regulatory capacities of the Region and facilitate the adoption of common standards and the exchange of information for regulatory decision making.
Through strengthened and efficient systems based on good regulatory practices that promote the adoption of harmonized standards and the use of decisions from other jurisdictions, equitable access to safe, effective and quality health technologies will be promoted, both in routine situations and in health emergencies.
Since 2012, following the first meeting in Washington DC, these authorities have been working to reinforce their commitment to advancing strengthened regional regulatory systems. "The Region hopes that the NRAs of Regional Reference that today occupy a space on the WHO provisional list can successfully secure their transition and designation as WHO Listed Authorities (WLA). This achievement will impact the use of their regulatory decisions by other jurisdictions (regulatory reliance), as well as the eligibility of products overseen by these authorities for procurement through PAHO revolving funds and WHO prequalification. PAHO and WHO reiterate their commitment to accompany the Region's NRAs in this process, in a coordinated manner".
NRAr meetings are held twice a year, and the next meeting will be held in December 2024.
This event was supported by Global Affairs Canada - GAC.
