List of equivalent agencies at partial or full trust level has also been updated; the mutual recognition list remains empty
This Monday (June 15, 2026), the federal government published Normative Instruction No. 451 of 2026 of the (National Health Surveillance Agency) in the (Official Gazette of the Union), which changes the rules for the recognition of foreign regulatory agencies considered equivalent.
The objective of the measure is to improve the health inspection process and analysis of CBPF (Certification of Good Manufacturing Practices) requests for manufacturers of medicines, biological products, active pharmaceutical ingredients and Cannabis products for medicinal purposes.
The standard modifies and establishes new criteria for defining the so-called AREE (Equivalent Foreign Regulatory Authorities) – international health bodies that have regulatory standards considered compatible with those of Anvisa. The change should facilitate the entry and certification of regulated products in Brazil, as it will take advantage of international assessments in its decisions.
What changes:
- Anvisa’s Collegiate Board, after an evaluation, starts to include or remove foreign agencies from the list of their equivalents;
- decentralized authorities or bodies linked to a foreign regulator recognized as equivalent may be automatically included in the same level of trust, except when there is any specific restriction;
- Anvisa may, at any time, revoke or review the recognition granted to a foreign agency;
- the instruction also changes the analysis of CBPF requests. Now, Anvisa can use documents and information issued by recognized foreign authorities, reducing steps and avoiding the repetition of procedures already carried out by other regulatory bodies.
Companies must still present the documentation required in each certification process, and the final decision will continue to be made by Anvisa.
The new rule updated the list of authorities recognized at partial or full regulatory trust level:
- Alemanha — BMG (Federal Ministry of Health) e ZLG (Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices);
- Arábia Saudita — SFDA (Saudi Food and Drug Authority);
- Áustria — BASG (Austrian Federal Office for Safety in Healthcare);
- Bélgica — FAMHP (Federal Agency for Medicines and Health Products);
- Bulgária — BDA (Bulgarian Drug Agency);
- Canada — HC (Health Canada);
- Cingapura — HSA (Health Sciences Authority);
- Chipre — CyPHS (Pharmaceutical Services);
- Coreia do Sul — MFDS (Ministry of Food and Drug Safety);
- Croácia — HALMED (Agency for Medicinal Products and Medical Devices of Croatia);
- Dinamarca — DKMA (Danish Medicines Agency);
- Eslováquia — SIDC (State Institute for Drug Control);
- Eslovênia — JAZMP (Agency for Medicinal Products and Medical Devices);
- Espanha — AEMPS (Spanish Agency of Medicines and Medical Devices);
- EUA — US FDA (U.S. Food and Drug Administration);
- Estonia — SAM (State Agency of Medicines);
- Finland — FIMEA (Finnish Medicines Agency);
- França — ANSM (French National Agency for Medicines and Health Products Safety) e ANSES (Agency of Food, Environmental & Occupational Health Safety);
- Grécia — EOF (Greek National Organisation for Medicines);
- Holanda — IGJ (Health and Youth Care Inspectorate);
- Hungria — NCPHP (National Center for Public Health and Pharmacy);
- Irlanda — HPRA (Health Products Regulatory Authority);
- Iceland — IMA (Iceland Medicines Agency);
- Italy — AIFA (Italian Medicines Agency);
- Japão — MHLW (Ministry of Health, Labour and Welfare) e PMDA (Pharmaceuticals and Medical Devices Agency);
- Jordânia — JFDA (Jordan Food & Drug Administration);
- Letônia — ZVA (State Agency of Medicines);
- Liechtenstein — AG (Office of Healthcare);
- Lithuania — SMCA (State Medicines Control Agency);
- Malta — MMA (Malta Medicines Authority);
- México — COFEPRIS (Federal Commission for the Protection Against Sanitary Risks);
- Noruega — NOMA (Norwegian Medical Products Agency);
- Polônia — CPI (Chief Pharmaceutical Inspectorate);
- Portugal — Infarmed, IP (National Authority of Medicines and Health Products, IP);
- Reino Unido — MHRA (Medicines & Healthcare Products Regulatory Agency);
- República Checa — SÚKL (State Institute for Drug Control) e ISCVBM (Institute for State Control of Veterinary, Biologicals and Medicines);
- Romênia — NAMMDR (National Agency for Medicines and Medical Devices of Romania);
- Suécia — MPA (Swedish Medical Products Agency);
- Suíça — Swissmedic (Swiss Agency for Therapeutic Products);
- Turquia — TMMDA/TITCK (Turkish Medicines and Medical Devices Agency);
- Taiwan — TFDA (Taiwan Food and Drug Administration);
- European Union — EMA (European Medicines Agency).
The highest level of trust, called Mutual Recognition, remains without any authority approved by Anvisa.
