Latin America Roundup: Top ANVISA regulator laments personnel crunch

In a rare media interview, a top regulator with the Brazil Health Regulatory Agency (ANVISA) detailed how short staffing is stymying the agency’s ambition to accommodate innovative health concepts and products.

Daniel Meirelles Fernandes Pereira, who serves on ANVISA’s five-seat directorate, which itself is currently short-handed, told Journal de Brasilia that ANVISA has introduced creative regulatory strategies to accommodate a flood of innovations, but that the agency remains constrained.

“We have a [health] market with a lot of appetite and innovation, both in Brazil and around the world. And the agency is increasingly having to challenge itself in its work processes to handle these registrations,” Pereira told the outlet in an April 14 interview.

Particularly challenging, Pereira said, are cell therapies and medical devices, such as stents that contain a pharmacological component, because the structure of ANVISA, which is established by Brazilian federal law, has not been changed to accommodate them.

The agency, Pereira said, “has the same structure it did in 1999.” Moreover, he said, “we had around 2,500 civil servants in the agency twenty years ago, and today we have around 1,600.” Meanwhile, “The companies have grown, production has increased, and more and more new products are arriving.” Many of the agency’s current staff are older and have been moved from other positions in Brazil’s federal government that were abolished, Pereira said, with only around 90 open positions available to fill with new people.

“The drug department of the [U.S. Food and Drug Administration] has around 8,000 people,” Pereira said. “Today, ANVISA has around 140 people in medicines. Of course, the United States is much bigger, but you see the size of the disproportion. This creates difficulties for us. We want to take a more proactive stance, to increase the number of inspections, to improve monitoring, and we can’t because of a lack of people.”

Perera said that ANVISA is requesting, at a minimum, that lawmakers double its current number of open positions by yearend.

Interview (Portuguese)

Brazil approves chikungunya vaccine

ANVISA announced on 14 April that it had approved a new vaccine against the Chikungunya virus. The approval represents the first time the product, a live attenuated recombinant vaccine developed by the Austrian pharmaceutical company Valneva and manufactured in Germany, will be marketed in a Chikungunya-endemic country. The single-dose vaccine, branded as IXCHIQ, was clinically tested in Brazil and was approved in the United States and the European Union last year. It is indicated for use in adults aged 18 and older who are at increased risk of exposure. ANVISA regulators had participated in the evaluation of IXCHIQ by the European Medicines Agency under a special program that invites some non-EU agencies to weigh in on certain decisions.

Statement (Portuguese)

Regional medicines agency is floated again

At the 2025 meeting of the Community of Latin American and Caribbean States (CELAC), an economic meeting of 33 countries, government heads led by Colombia President Gustavo Petro once again publicly advocated for the creation of an international medicines agency for the region.

The idea first gained steam after the COVID-19 pandemic, which left public health officials in the region with difficulty acquiring supplies and vaccines. Conceived as a reliance effort to ease movement of products across regional borders and stimulate local production of low-cost generics and vaccines, the proposed agency was christened AMLAC and formally announced in April 2023 by regulators in Mexico, Cuba, and Colombia.

Since then, AMLAC appears to have lost momentum, even though reliance initiatives remain popular across Latin America. Early this month, for example, regulators with Cuba’s Center for State Control of Medicines and Medical Devices (CECMED) visited Chile’s Public Health Institute (ISP) under a cooperation agreement.

At the CELAC meeting, which took place in Tegucigalpa, Honduras on 8-9 April, Petro revived the concept of an interconnected medicines agency, while Mexico president Claudia Sheinbaum mentioned that Mexican and Brazilian regulators were seeking to combine forces on medicines production, according to one press report. This suggests a change in priorities from the past year, when Mexican industry and government were heavily focused on nearshoring, or producing medical devices and other products for export to the United States.

In an editorial that followed the CELAC congress, Colombian health economist Germán Velásquez took the integration concept a step further and argued for the creation of a “common market” for pharmaceuticals across the region in response to the protectionist US trade policy of President Donald Trump.

Peru: More than 50 drugmakers lack GMP certification; medicines agency gets new director

A report in Peruvian health news outlet Salud con Lupa has found that 51 labs with products licensed for sale in Peru lack a good manufacturing practices (GMP) certification from Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID).

Inspectors with DIGEMID are obliged by law to visit production plants, including those located in other countries, and issue the certifications. Of more than 80 plants deemed not compliant after inspections by DIGEMID, 51 still have products legally for sale in Peru, due to a loophole that allows lots that have already been cleared to be sold even after a plant flunks inspection, though new lots from such plants cannot be imported.

The report was published on 9 April and based on details found in official letter sent by a former director of DIGEMID, Moisés Mendocilla, to authorities at Brazil’s tax agency.

The report follows a recent scandal at DIGEMID, after faulty lots of a nationally-manufactured saline IV solution killed four people in February and March, and sickened many more. Mendocilla stepped down, replaced by one director who lasted two days in the role, then an interim director. On 10 April, Delia Dávila Vigil, a surgeon with extensive public health experience, according to media reports, was named the agency’s new director.

Bolivian regulators, industry meet to address high prices

On 10 April, the head of Bolivia’s consumer protection agency met with drug regulators and industry representatives to discuss recent spikes in local drug prices and how to counter them, according to Bolivian media reports.

The meeting was convened by Bolivia’s vice minister for consumer rights, who complained that prices for some drugs have jumped by 200% in the past year. Representatives of Bolivia’s pharmaceutical trade associations deemed this an exaggeration.

Nonetheless, the trade groups acknowledged a pricing problem and urged the Bolivian government to ease restrictions for the sector that would allow it to access more foreign currency. Bolivia’s currency regulations impose significant restrictions and taxes on foreign bank transfers. This, the industry representatives said, is contributing to the price hikes, because imported products and active ingredients must be paid for in dollars.

A report in the Bolivian media outlet La Patria said that the State Agency for Medicines and Health Technologies (AGEMED) agreed to provide more information and clarity on current pricing, and will update its list of available medicines and their prices in Bolivia.

Latin America Roundup: Top ANVISA regulator laments personnel crunch

Related topics

Recommended content

Welcome to the new RAPS Digital Experience