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January 28, 2025
by Jennie Smith

Latin America Roundup: Agencies face uncertainties over US WHO withdrawal, USAID suspension

No Latin American health or regulatory agency has publicly weighed in on US President Donald Trump’s recent executive orders withdrawing the US from the World Health Organization (WHO) by early 2026 and suspending virtually all foreign aid operations for at least 90 days.
 
Nonetheless, both actions are likely to have serious consequences for the agencies, which have sought to increase international cooperation following the COVID-19 pandemic, when many struggled to attain vaccines and other crucial health supplies. The Pan-American Health Organization (PAHO), the regional arm of WHO, has been a key driver of regulatory reliance and harmonization initiatives meant to improve access to medicines and supplies throughout Latin America and the Caribbean.
 
While the United States’ position with regard to PAHO is unclear, the US Agency for International Development (USAID), a major PAHO partner for three decades, has been all but frozen, with leadership on administrative leave and funding and activities suspended pending what the White House called a “deliberate and judicious review.”
 
One PAHO initiative in which USAID has participated has been to facilitate local vaccine development and production. On 15 January, PAHO announced a partnership between Pfizer and Sinergium, an Argentinian manufacturer, to make the Prevenar-20 pneumococcal vaccine in Argentina, as a way of increasing regional access to it. On 21 January, the Argentinian health news outlet Pharmabiz.net expressed concern that the withdrawal of US support would jeopardize that effort.
 
INVIMA reports independent accreditation of its labs
 
Colombia’s National Institute of Food and Drug Surveillance (INVIMA) announced on 23 January that it had undergone an accreditation process to validate the work of its laboratories. INVIMA said results from seven labs – including those that test pharmaceutical products and medical devices for the agency – had been analyzed and validated by the independent Colombian accreditation body ONAC, and that the resulting certifications will both increase public confidence in INVIMA’s work and support “the acceptance processes of [Colombian] products in international markets,” according to a statement by agency director Francisco Rossi.
 
INVIMA statement (Spanish)
  
Panama adopts automatic registrations
 
Panama’s Health Ministry on 13 January made regulatory reliance measures official, decreeing that any medication registered by a WHO-listed authority would be granted automatic registration in Panama within 10 days, and would be exempted from further procedures.
 
Rule (Spanish)
 
ANMAT commences internal reviews
 
As part of ongoing efforts to increase bureaucratic efficiency, Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) has begun convening an internal review committee, the agency said in a statement 24 January. At the latest meeting, held earlier the same week, members discussed audit reports and compliance with prior commitments. They also proposed creating formal manuals for procedures and a new database “that allows for streamlining of procedures related to the export of medicines, food and medicinal products,” ANMAT said. Also, as part of its duties, the new committee will seek to demonstrate “proof of legitimate payments” for goods and services, the agency said.
 
Statement (Spanish)
 
Honduras sets up pharmacovigilance centers
 
The government of Honduras announced through its official news channel on 22 January that it had created national centers to monitor the safety and efficacy of medicines and devices in the country.
 
Operating under the authority of country’s Health Regulatory Agency (ARSA), one center will oversee devices, while a separate pharmacovigilance center will oversee medicines. A food safety monitoring agency is also being established as part of ARSA. 
 
“In a global context where treatments are increasingly complex, the associated risks, such as unexpected adverse reactions and serious side effects, also increase. [The centers] will allow continuous evaluation of medications, medical devices and other health products, identifying and mitigating possible risks for the population,” the Honduran government said in its announcement.
 
Statement (Spanish)
 
ANVISA lists a host of new services
 
The Brazil Health Agency (ANVISA) published on 24 January a list of new services it will offer.  More than a dozen novel categories have been established that cover different patient and industry requirements. The new categories include requests to register or transfer ownership of advanced therapy products; consents, cancellations and modifications of consent in clinical trials for advanced therapies; compassionate use authorization requests; requests to use non-authorized products; expanded access and post-study supply of advanced therapy products; and requests related to the importation of human gametes and embryos.
 
Statement (Portuguese)
 
Brazil and Denmark renew technical exchange
 
Regulators in Brazil and Denmark have renewed an ongoing “strategic cooperation” plan to fund another three years of technical exchanges, with activities starting in April, ANVISA said in a statement on 22 January. Proposed themes for ANVISA’s exchange with the Danish Medicines Agency (DKMA) include medical devices, the use of artificial intelligence in regulatory processes, and management of antimicrobial resistance, according to ANVISA.
 
Statement (Portuguese)

New Uruguay health minister seeks to create medicines agency
 
Starting in March, when a new left-wing coalition government takes power, Uruguay’s public health ministry will be led María Cristina Lustemberg, a pediatrician and former legislator. Lustemberg will replace current Health Minister Karina Rando. According to the Uruguay news outlet La Diaria, Lustemberg has proposed to create a distinct medicines agency in Uruguay, which currently lacks one. Having a separate agency would allow for expanded public access to medicines, she has argued.
 
Article in La Diaria (Spanish)
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