Brazil’s ANVISA is commonly recognised as LatAm’s leading national medicines regulator and is defined by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr) for medicines and vaccines. As part of our Transformative 2023: Regional Pharma Trends report, PharmaBoardroom’s Patrick Burton explores some of the key recent updates for the agency.


There is already a perception that the agency is a reference for agencies in South and Central America

Antonio Barra Torres, director-president, ANVISA


WHO 4: ‘The Summit of Everest’

The agency is now targeting World Health Organisation (WHO) maturity level 4 (ML4) classification, which would further cement this status. ML4 regulators are a certified reference point on drug and vaccine regulation for countries that do not have the internal capacity to do so internally. Currently, only Singapore’s HSA and South Korea’s Ministry of Food and Drug Safety hold such a ranking.

As Antonio Barra Torres, director-president of ANVISA explains. “We have the [ML3] certification, but we still have to climb to the last step. This is very important on the international stage and in the regional bloc for Brazil to regain its position on the international stage. Self-assessment will take place in 2023 and we are predicting that the WHO inspection will take place in 2024. Additionally, PAHO has offered to inspect us, as part of the preparatory process.”

“There is already a perception that the agency is a reference for agencies in South and Central America. But when you get to level four, it is like reaching the summit of Everest. There is nothing higher. The 30 percent of the Brazilian economy that ANVISA inspects will be done so by an agency at the top level, which has repercussions for exports on the world stage and will be an especially important strength factor for the Brazilian economy.”


Industry Praise

One of Brazil’s most significant selling points as a pharma investment destination is the progress made by ANVISA in allowing earlier and broader access to innovative new therapies. Industry stakeholders are keen to praise the regulator, with FIFARMA’s Yaneth Giha positing that “ANVISA of Brazil is still the leading agency in the region, thanks to its openness, ability to work with other stakeholders, and awareness of global industry trends.”

Sarah Aiosa of MSD adds that “we have seen some great achievements in LatAm, such as ANVISA’s participation in Project Orbis, a programme which provides a framework for the concurrent submission and review of innovative oncology products among international partners. I am excited to see how the learnings from pilot projects such as this can be scaled up elsewhere.”

GSK Brazil Country Manager Andre Vivan da Silva is similarly effusive about ANVISA’s participation in Project Orbis. “Compared to my experiences in other countries, the regulatory agency in Brazil is quite advanced. Through Project Orbis, ANVISA and the US FDA have connected with respect to timing. There is a fast track for oncology drugs, so as soon as the FDA approves a drug, ANVISA can then approve it in a matter of weeks. This is a real example of ANVISA being timely.”


A Challenging 2023

Despite the broad cross-stakeholder recognition of its effectiveness and timeliness, ANVISA did have to survive a dramatic attempt to curb its powers earlier this year, As reported in Regulatory Focus, in February 2023 a voting bloc in the Brazilian congress attempted to reduce ANVISA to a non-rulemaking body tasked with implementing the decisions of a body approved by the legislative branch of government. Following the swearing in of ‘Lula’ as president, there had been moves to curb the powers of several highly autonomous agencies in the country.

The attempt to hamstring ANVISA was met with widespread opposition and over 30 entities signed a manifesto expressing their support for the regulator to stay as is. As of December 2023, ANVISA remains able to make its own rules and answerable only to the executive branch.