ANVISA (Agência Nacional de Vigilância Sanitária, the Brazilian Health Regulatory Agency)

Who regulates medicines in Brazil?

In one sentence

ANVISA is Brazil's health regulator: an autonomous federal agency under the Ministry of Health that licenses medicines, devices, food and more.

Law 9.782 of 26 January 1999 made it a special-regime autarchy with administrative independence, stable directors and its own finances, run by a board of five confirmed by the Senate. It coordinates the National Health Surveillance System with the states, and every adverse event report it receives goes on, anonymised, to the World Health Organization (WHO).

Where it sits

MinistryMinistério da Saúde, to which the agency is linked
BoardDiretoria Colegiada: five directors, nominated by the President, approved by the Senate
AgencyANVISA, Brasília, 1,517 staff
ReportsVigiMed, the WHO’s VigiFlow in BrazilForwarded to VigiBase in Uppsala

Think of it like this

Think of a federal office with its own purse, directors nobody can sack on a whim, and state inspectorates working to its rulebook. Every report it gets, it copies to a library in Sweden.

Key insights

Independent by statuteEvery report goes to Uppsala15 days, 72 hoursAt the table

The 1999 law defines the agency’s special status in one line: administrative independence, stable directors, financial autonomy. Five directors run it, nominated by the President and approved by the Senate. Its surveillance fee brought in 739 million reais in 2024; it employed 1,517 people.

Since 10 December 2018 Brazil’s reporting system, VigiMed, has been the WHO’s own VigiFlow. The national centre inside ANVISA has represented Brazil in the WHO programme since 2001, and every notification is evaluated and forwarded, anonymised, to the global database. Chapter 1 tells the story.

A registration holder notifies every serious event that occurred in Brazil, expected or not, within 15 calendar days, and an urgent safety situation within 72 hours. Everything else waits for the periodic benefit-risk report. In the first half of 2024 VigiMed took 27,555 notifications, 82 percent of them serious. Chapter 2 sets the clocks.

ANVISA is a regulatory member of the International Council for Harmonisation (ICH) and sits on its Management Committee until June 2026. It joined the inspectors’ Pharmaceutical Inspection Co-operation Scheme (PIC/S) in January 2021 and hosted both the PIC/S and the International Coalition of Medicines Regulatory Authorities (ICMRA) meetings in Brasília in November 2024.

Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with Europe 4 Test yourself

Chapter 1

Which three moments made ANVISA what it is?

Pick a year. Each one set a rule the agency still works by.

1999Born of a provisional measure2018The database moves to Uppsala2020A rulebook for companies, revised for 2026

Born of a provisional measure

At the end of 1998 the President issued a provisional measure, and on 26 January 1999 Congress turned it into Law 9.782. The law defined a National Health Surveillance System shared by the Union, the states and the municipalities, and created the agency to coordinate it: an autarchy under a special regime, linked to the Ministry of Health.

One paragraph fixed its character: “independência administrativa, estabilidade de seus dirigentes e autonomia financeira”. The law also told it to register products, grant manufacturing certificates, collect the surveillance fee and to establish and run the country’s pharmacological surveillance systems. Its board, Senate-approved, began with up to five members on three-year terms.

What it left behind: a regulator whose independence is written into its founding law, not into a decree.

The database moves to Uppsala

Brazil had a national monitoring centre inside ANVISA since May 2001, its voice in the WHO programme. On 10 December 2018 the agency switched off its own reporting system, Notivisa, and put citizens, professionals and companies on VigiMed, which is VigiFlow, the tool the WHO runs for its member centres.

Since then every notification is evaluated in Brasília and forwarded, stripped of names, to VigiBase. Reporting rose with it: since 2021 Brazil has beaten the WHO benchmark of 200 reports per million inhabitants, with pharmacists the fastest-growing reporters, and 2024 came in at 268.

What it left behind: a national database that is also a slice of the world’s.

A rulebook for companies, revised for 2026

Resolução da Diretoria Colegiada (RDC) 406 of 22 July 2020 wrote the good pharmacovigilance practices for registration holders: one named responsible person and a substitute, every serious event in Brazil within 15 calendar days, urgent situations within 72 hours, the rest in the periodic benefit-risk report. In 2024 ANVISA ran 14 inspections against it and assessed 92 risk management plans.

RDC 967 of 18 March 2025 rewrote the reporting article for the data age: from 21 March 2026 every case goes through VigiMed in the E2B(R3) format of the International Council for Harmonisation (ICH), with medicines and vaccines coded in WHODrug, the Uppsala dictionary.

What it left behind: Brazilian deadlines, in the world’s data format.

Chapter 2

Your report, their clock

A case has reached your company. The board’s resolution, Resolução da Diretoria Colegiada (RDC) 406, sets the deadline with two questions: is it serious, and did it happen in Brazil? Pick a cell.

In BrazilAbroadSeriousSerious, hereSerious, abroadNot seriousNot serious, hereNot serious, abroad

Or it is something else: an urgent safety situation or a medicine that did not work

Every serious adverse event that occurred in Brazil, expected or unexpected, spontaneous or solicited, goes through VigiMed within 15 calendar days of the day the information reached you. A valid report has four elements: reporter, patient, event, suspect medicine. New clinically relevant information restarts the clock. RDC 406/2020, arts. 30, 32 and 33

Cases from abroad and non-serious cases are not sent one by one. They belong in the periodic benefit-risk report, literature cases included. RDC 406/2020, art. 31

An urgent situation in the use of your product that affects patient safety is told to ANVISA within 72 hours. RDC 406/2020, art. 34, § 1º

Therapeutic ineffectiveness counts as a case when, in your own judgement, it put a life at risk; for vaccines and contraceptives, always. Then the 15-day clock applies. RDC 406/2020, art. 30, § 1º

Todos os Eventos Adversos Graves (esperados e inesperados), relatados de forma espontânea ou solicitada, ocorridos em território nacional, no prazo máximo de 15 (quinze) dias corridos.
RDC 406/2020, artigo 30: every serious event on Brazilian soil, expected or not, within 15 calendar days

Citizens, health professionals and study sponsors use the same VigiMed. In the first half of 2024 it took 27,555 notifications for medicines and vaccines, 82.4 percent of them serious and 6.7 percent fatal. The anonymised cases travel on to the WHO.

Chapter 3

Side by side with Europe

Brazil writes its own rules. Five places where they differ from the European Union’s (EU).

	The EU rule	The Brazilian rule
Who decides	The European Commission, on the opinion of the European Medicines Agency (EMA), for centralised medicines	A board of five directors, Senate-confirmed, inside an agency with statutory independence
Where a serious case goes	EudraVigilance within 15 days, wherever it happened	VigiMed within 15 calendar days, for cases in Brazil only; foreign cases in the periodic report
A non-serious case	90 days if it happened in the Union	No single-case report; the periodic benefit-risk report
A safety issue	Assessed at the EMA’s safety committee	The company tells ANVISA within 72 hours if urgent
Who inspects you	The national competent authority, in cooperation with the EMA	ANVISA with the state inspectorates, which count as one PIC/S authority; 14 pharmacovigilance inspections in 2024

Show the legal references

Who decides: Regulation (EC) No 726/2004, Article 10(1); Lei 9.782/1999, art. 3; Anvisa, Diretoria Colegiada, Composição.
Serious cases: Directive 2001/83/EC, Article 107(3); RDC 406/2020, arts. 30 and 31.
Non-serious cases: Directive 2001/83/EC, Article 107(3); RDC 406/2020, art. 31.
Safety issues: RDC 406/2020, art. 34.
Inspections: Directive 2001/83/EC, Article 111(1); PIC/S membership list; Relatório de Gestão 2024.

Same 15 days as Brussels, but only for Brazilian soil, and with a 72-hour alarm the company pulls itself.

The facts, in one place

What it is	An autarchy under a special regime, linked to the Ministry of Health, created by Lei 9.782/1999 and coordinating the National Health Surveillance System.
Since	26 January 1999, from a provisional measure of 1998.
Who decides	The Diretoria Colegiada, five directors nominated by the President and approved by the Senate. 1,517 active staff in 2024.
Seat	Brasília; offices at ports, airports and borders across the country.
Money	Financial autonomy by law; the health surveillance fee brought in 739 million reais in 2024.
2024 in numbers	27,555 notifications in the first half; 268 reports per million inhabitants; 92 risk management plans assessed; 14 pharmacovigilance inspections.
Member of	The International Council for Harmonisation (ICH) as a regulatory member, on its Management Committee to June 2026; the International Coalition of Medicines Regulatory Authorities (ICMRA); the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since January 2021; the WHO Programme for International Drug Monitoring, through the national centre since 2001.

Don’t confuse it with: the Ministry of Health

ANVISA

The regulator

Decides: registrations, manufacturing certificates and safety measures, through its own board
Is: an autarchy linked to the Ministry, independent by statute
Example: receives a medicine’s adverse event in VigiMed and forwards it to the WHO

Ministério da Saúde

The ministry

Runs: health policy, the public health system and the national immunisation programme
Is: the government department the agency answers to; the President picks the directors
Example: collects vaccine adverse events in its own system, named after the public health system, the Sistema Único de Saúde (SUS), now being joined to VigiBase

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“A Brazilian registration holder must send ANVISA its serious cases from abroad within 15 days.”

MythTruth

MythYou got it.Not quite.

Article 30 of RDC 406 covers serious events that occurred in national territory. Everything else, foreign cases included, belongs in the periodic benefit-risk report under article 31.

“A life-threatening lack of effect is reported like a serious adverse event.”