01/26/2026 | Anvisa-Gov.br

https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-completa-27-anos-de-defesa-da-saude-publica 

Learn a little about the history, achievements, commitments, and challenges of the Agency that has become an international reference in sanitary surveillance.

Anvisa celebrates 27 years of existence this Monday (January 26). Created in 1999, through Law 9.782, the Agency was born in a context of great challenges in Brazil. Throughout its history, it has promoted several advances that have had a significant impact on the lives of the population, becoming the powerhouse it is today: one of the most important bodies of the Unified Health System (SUS) and an international reference, acting in various regulatory forums globally. To reach this point and consolidate itself as a technically strong regulatory agency, accounting for progress and innovations in numerous areas, Anvisa has always maintained its commitment to the safety, efficacy, and quality of the products and services it regulates, making decisions anchored in data and scientific evidence.

Essential to the lives of Brazilians and the country's economy, Anvisa's work encompasses the regulation, registration and authorization, inspection, and monitoring of products. Linked to the Ministry of Health, the Agency is also responsible for coordinating the National Health Surveillance System (SNVS).

To give an idea of ​​its size, Anvisa regulates sectors that represent more than 20% of Brazil's Gross Domestic Product (GDP), such as the food, health products, pharmaceuticals, pesticides, cosmetics, sanitizers, and tobacco industries.

Regulation also includes analytical laboratories, health services, and the Brazilian Pharmacopoeia, as well as health surveillance at ports, airports, and borders, and therapeutic products and procedures involving blood, tissues, cells, and organs.

Yes, it's time to look to the future. But it's also necessary to look in the rearview mirror and remember the achievements. Shall we?

Social Participation

Over this time, especially in recent years, Anvisa has intensified mechanisms and channels for social participation in technical matters. The strength of Anvisa's technical decisions comes from broad consultation with society at each step of the development of standards or the reformulation and updating of regulations.

Public hearings, public consultations, public input sessions, open seminars with real-time transmission for the presentation of the Agency's proposals, permanent and direct channels of interaction with society, openness to receiving suggestions for topics that will be part of its regulatory agenda, and real-time transmission of Anvisa's Board meetings are some examples of respect for public contributions and effective social participation.

We are talking about the Agency's commitment to best regulatory practices, based on dialogue with all stakeholders, in addition to conducting well-structured regulatory impact analyses and evaluating the results of regulations. This is evidenced by the fact that, in May 2025, Anvisa was awarded the Gold Seal of Regulatory Quality, the highest distinction granted by the Federation of Industries of the State of São Paulo (Fiesp).

Regulatory Frameworks

Anvisa is focused on establishing new regulatory frameworks that respond to the challenges of a constantly transforming world, with major and revolutionary technical and scientific discoveries.

In the last quarter of 2025, resolutions were published on good practices for dental services and occupational risk assessment for pesticides. Resolution of the Collegiate Board (RDC) 1.002/2025 established the Good Operating Practices requirements for all services providing dental care in the country. The standard aims to guarantee professional qualification, humanization of care and management, as well as reduce and control health risks for professionals, patients, the community, and the environment.

RDC 998/2025 regulated the assessment of occupational risk and exposure to pesticides. Until then, Brazilian regulation mainly addressed the risk to consumers through pesticide residues in food. In other words, Brazil now has, for the first time, clear rules for verifying the risk of exposure to pesticides for workers, operators, residents, and people who pass through areas where these products are used.

Also in late 2025, Anvisa approved the new framework for herbal medicines in Brazil. Resolution 1004/2025 defined the categories of herbal medicine and traditional herbal medicine and established, in addition to what is foreseen in RDC 948/2024, the minimum requirements for the registration of herbal medicines, and for the registration and notification of traditional herbal medicines.

One of the central points in the update of this regulation is the plant extracts that give rise to the herbal medicine, with changes in the way industries produce and operate these extracts. In short, the new rule simplified the processes in order to allow the expansion of the use of biodiversity in herbal medicines. This is because, despite having the greatest biodiversity in the world, Brazil still has a reduced number of herbal medicines. Currently, there are about 350 regulated by Anvisa.

Today, new regulatory frameworks are under consultation, such as those for food and packaging, medical devices, and new rules for medicinal cannabis products.

Vaccines

A retrospective of this last period, which led the Agency to complete 27 years of existence, also points to a very promising horizon regarding advances in the field of immunizations.

In December 2025, Anvisa published the registration of the dengue vaccine developed by the Butantan Institute. This act marked the conclusion of the regulatory process and allowed the production and commercialization of the immunizing agent in the country. This is the first dengue vaccine to be produced by a national laboratory, and it will be offered exclusively by the SUS (Brazilian Public Health System).

A few months earlier, precisely in April, Anvisa also approved the registration of the first vaccine for Chikungunya. The immunizing agent, also from the Butantan Institute, is indicated for the prevention of the disease in people aged 18 or older who are at increased risk of exposure to the virus. For the publication of the registration, Anvisa, in conjunction with Butantan, defined a Commitment Agreement that foresees the carrying out of studies on the effectiveness and safety of the vaccine, and active pharmacovigilance activities to expand knowledge about the efficacy and safety profile of the vaccine.

Advanced Therapies

The approval of the regulation on the sanitary registration of advanced therapy products established the regulatory basis for developing and registering high-technology products based on human cells and genes, becoming a reference in Latin America. Since the path was opened for the country to develop and register products from human cells and genes, patients suffering from complex diseases without medical alternatives have renewed hope for a better quality of life.

An example of this is the authorization, in November 2025, for clinical studies with an advanced therapy product for the treatment of spinal muscular atrophy (SMA) type 1, the most severe form of the disease. This is a rare genetic disease that causes progressive loss of muscle strength and can compromise the survival of children in their first years of life.

The study is being developed by a North American company in partnership with the Oswaldo Cruz Foundation (Fiocruz). Fiocruz is directly involved in the clinical development of the product and has signed a technology transfer agreement. Therefore, once registered by Anvisa (Brazilian Health Regulatory Agency), the drug can be produced in Brazil, contributing to national autonomy in the field of gene therapies.

Alzheimer's

With the aging population, Alzheimer's disease is considered the "disease of the century," being the leading cause of dementia in the elderly. While the increase in life expectancy is celebrated, it is also true that people want to reach old age with health and preserved cognitive functions.

That is why the approval of a groundbreaking drug for the disease in January of this year was so celebrated. Lecanemab is a monoclonal antibody from the class of biological products approved by Anvisa (Brazilian Health Regulatory Agency) for the initial phase of Alzheimer's disease, that is, for people diagnosed with mild cognitive impairment or in the mild stage of dementia. With the registration, lecanemab is authorized for distribution and use in the country.

Tobacco Control

Anvisa was awarded the World No Tobacco Day 2025 Award by the World Health Organization (WHO). The Agency stood out due to pioneering regulations and also because of its firm resistance against the tobacco industry. In 2024, the Agency reaffirmed the prohibition of electronic smoking devices in the country, after several public consultations and regulatory analyses.

Good Practices

Anvisa has implemented quality standards in outpatient clinics, doctor's offices, hospitals, and surgical centers. Among the regulations, the Good Practices in Health Services and the Quality Improvement Program stand out. In other words, the quality and safety of health services can be measured based on the Agency's standards.

There are also advances in monitoring adverse events in these environments, through the formation of national networks that report data on outbreaks, infections, and microbial resistance. With this information and in coordination with state and municipal health surveillance agencies, measures are adopted to respond to crisis situations with the necessary speed and urgency.

Workforce

Committed to replenishing its technical staff, Anvisa obtained authorization to call up approximately 100 candidates who passed the 2024 competitive examination for a new class of the training course, which concluded on December 21, 2025, with the application of the final exam. The arrival of the new staff will strengthen the country's regulatory capacity and ensure faster responses to health demands. The reinforced workforce contributes, for example, to accelerating procedural analyses.

International Scenario

The recognition of the technical quality of the decisions made by Anvisa internally and the positions defended by the institution in the environment of international organizations and multilateral bodies are recognized worldwide.

Anvisa belongs to the group of regulators with global impacts, working not only to protect its own population, but also to establish global standards of quality, safety and efficacy. Its leadership and expertise are fundamental in international discussions on health regulation and it frequently collaborates with institutions such as the World Health Organization (WHO) to improve health around the world.

Optimization of the Analysis Queue

In order to reduce regulatory backlog, RDC 997 was published in November 2025. This regulation established exceptional and temporary measures to optimize the analysis queue for clinical research approvals and applications for registration and post-registration of medicines and biological products. The resolution will be in effect until December 31st of this year. The objective is to reduce analysis times through the creation of a task force within the Agency itself and also through a mechanism called reliance, or regulatory trust.

Reliance, or regulatory trust, is a practice adopted by health regulatory authorities to optimize and accelerate their decision-making processes. It involves the possibility for a national regulatory authority to consider and utilize, in whole or in part, the assessments, inspections, and decisions of other trusted regulatory authorities or international bodies, always respecting its sovereignty and independence.

The use of reliance does not mean delegating responsibilities, but recognizing the value of the work already done by other authorities, contributing to the more efficient use of resources, reduction of rework, and promotion of timely access to safe, effective, and quality products.

It is also worth remembering that there is now a situation room within the Agency that monitors the evolution of waiting lists. In addition, a monitoring committee has been established so that this entire process is followed by civil society and the regulated sector, ensuring transparency in the actions.

And time does not stop...

All this was accomplished amidst challenges such as those related to hair pomades and styling pastes – which caused everything from allergic reactions to keratitis and temporary blindness – methanol poisoning, and the misuse and counterfeiting of slimming pens. All these challenges demand quick responses from Anvisa. In the case of methanol, the Agency took measures to increase the production of pharmaceutical ethanol and authorize the exceptional importation of Fomepizole, used as an antidote in cases of methanol poisoning.

For all this and much more, congratulations Anvisa!