Latin-America Roundup: Mexico, Brazil draft agreements on reliance measures

Preliminary trade agreements between Brazil and Mexico include several key initiatives on vaccines, medicines, and regulatory reliance, the Mexican government said on 28 August.
 
At a meeting in Mexico City late last month, Mexican President Claudia Sheinbaum, and other officials, welcomed a delegation led by Brazil’s Vice President Geraldo Alckmin, to discuss bilateral agreements in the health, agricultural, and energy sectors. Final agreements are expected to be signed in 2026.
 
Two separate health-related memoranda of understanding resulted from the meetings.
 
The first, between Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) and the Brazil Health Surveillance Agency (ANVISA), aims to increase regulatory reliance between the two agencies. The reliance initiatives would speed product approvals, facilitate clinical research and allow for joint or reciprocal certification of pharmaceutical production plants, including plants in other countries, according to the statement by Mexico’s government.
 
The second memorandum, between Biological and Reagent Laboratories of Mexico (BIRMEX) and Brazil’s Oswaldo Cruz Foundation (FIOCRUZ), promotes collaboration on the production of vaccines and active pharmaceutical ingredients. BIRMEX and FIOCRUZ are both state-owned manufacturers of vaccines, reagents and other biological products for their respective public health systems, although BIRMEX, in recent years, has functioned mainly as a purchase consolidator and distributor of essential medicines.
 
The BIRMEX-FIOCRUZ agreement focuses on vaccines against dengue and other arboviruses. It also outlines production of coagulation factors, albumins and immunoglobulins for the Mexican and Brazilian health systems. A Mexico-Brazil health committee, with monthly meetings, will be created to monitor timely progress on these initiatives.
 
“Mexico and Brazil share a long and deep bilateral relationship that lives up to our responsibilities as the two largest economies in Latin America,” Mexico’s health secretary, David Kershenobich, said on announcing the agreements. Kershenobich praised Brazil’s government as for its “humanist vision” that promotes “health as a right, scientific and technological development, and local production to strengthen health sovereignty.”
 
Statements: COFEPRIS (Spanish), ANVISA (Portuguese)

Argentina names interim medicines director, arrests made over tainted fentanyl

Gastón Morán, a biochemist with longtime agency experience, has been named interim director for medicines at Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT), the agency said in a statement 22 August.

Morán, whose term is scheduled to last six months, replaced Gabriela Carmen Mantecón Fumado as head of the National Medicines Institute, a division of ANMAT. The change came one day after ANMAT’s director of post-marketing surveillance, Mariela Andrea García, was also pushed out of the agency.

Media outlets in Argentina have ascribed the agency shakeup to leaked documents showing that ANMAT officials failed to act immediately after uncovering serious manufacturing deficiencies at a plant owned by HLB Pharma, which made fentanyl citrate for use in hospitals. Vials of HLB fentanyl, produced after ANMAT’s inspections, were found to be contaminated with harmful bacteria in May 2025. Approximately 100 people in hospitals across Argentina are believed to have died after being treated with the drugs.

ANMAT, in its statements, has not acknowledged that the personnel changes relate to the fentanyl scandal.
 
On 21 August, 10 employees or affiliates of HLB Pharma were arrested in Argentina as part of an ongoing investigation, according to a report in the Buenos Aires Herald. Those arrested include members of company’s senior management team, the company’s purported owner, and several members of his family.
 
Not all the contaminated fentanyl vials are yet accounted for. Health officials in neighboring countries, including Paraguay, have expressed concern about the possibility of them reaching their institutions.
 
On 28 August the World Health Organization issued a global alert about the HLB fentanyl, saying that all products made by the company should be regarded as suspect and not used.
 
Statement (Spanish)
 
Three new directors at ANVISA
 
Three new directors have begun work at ANVISA, the agency said in a statement on 1 September. All of them were nominated by Brazil’s president and confirmed by the country’s senate before being sworn in on 29 August.
 
ANVISA’s governing structure comprises a five-member directory board, with each director responsible for the oversight of various units. Director terms last five years.
 
Economist Leandro Pinheiro Safatle is the new President-Director, replacing Antonio Barra Torres, who served in the position since November 2020. Daniela Marreco Cerquiera, a molecular biologist and former pharmacovigilance specialist with the agency, heads the second directorate, filling a vacancy left by Meiruze Souza Freitas. Thiago Lopes Cardoso Campos, a lawyer specializing in health law and policy, replaces Alex Machado Campos as head of the third directorate.
 
ANVISA’s second and third directorates have extensive oversight responsibilities that include, respectively, medicines and medical devices.
 
Statement (Portuguese)
 
Chile boosts budget for device regulation
 
Chile’s economic development agency has allotted approximately $2.6 million to country’s Public Health Institute (ISP) to improve its capacity to regulate medical devices.
 
In a statement issued 25 August, ISP said that fewer than 1% of all high-risk devices for sale in Chile are regulated nationally. The issue came into stark relief during the pandemic, when the ISP lacked the means to certify respirators produced in Chile, which prevented the devices from being used in hospitals.
 
The five-year grant will allow ISP to “to accompany national producers and innovators from the beginning, ensuring that the devices comply with international standards of good manufacturing practices,” according to the statement. It will also “open the door for Chilean companies to export [their products] with regulatory support.”
 
The project will involve updating standards, regulations and technical guides; developing formal regulatory procedures for devices; and training and hiring technical staff.
 
Statement (Spanish)
 
Brazil to allow priority review of GLP-1 medicines
 
On 22 August ANVISA said it would allow makers of semaglutide and liraglutide, two glucagon peptide 1 (GLP-1) receptor agonist drugs used in treating diabetes and obesity, to seek priority review for product approvals. According to an analysis published in Lexology by lawyers with RNA Law, a Brazilian firm, health ministry officials had requested the fast-tracking for semaglutide- and liraglutide-based products, calling them important to the public health system. Currently liraglutide is being produced in Brazil under a public-private partnership agreement, with local semaglutide production expected to begin next year.  

Statement (Portuguese)