This initiative consists of conducting an exhaustive process of evaluation and qualification of the Regulatory Agencies that voluntarily request so. This process is based on the compliance of critical indicators concerning the regulatory functions a national authority is to fulfill.

Along with other seven countries in the Region of the Americas, ANMAT constitutes a bloc called: “NRAr: National Regulatory Authorities of Regional Reference”.

In 2017, ANMAT was requalified as a “Regulatory Authority of Regional Reference for Medical Products and Vaccines” by the Pan American Health Organization (PAHO).

The Codex Alimentarius is a set of internationally accepted food standards and related texts that are presented in a consistent manner and approved by the Codex Alimentarius Commission (CAC). This Commission is the core constituent of the Joint FAO/WHO Food Standards Programme and was established by FAO (Food and Agriculture Organization) and WHO (World Health Organization), in order to protect consumers´ health and ensure the enforcement of food trade equitable practices. The aim of its publication is to guide and foster the development and establishment of definitions and requirements applicable to foods, with a view to boosting harmonization and, therefore, facilitating international trade.

Since its establishment in 1963, the Codex system has evolved in an open, transparent and inclusive manner to face new challenges. Codex standards are developed by the Committee of General Affairs and the Committee of Products and are based on robust scientific data supplied by independent international risk assessment organizations or ad-hoc consultations by FAO and WHO. Even when Codex standards are recommendations for voluntary application by its members, they are often a basis for national legislations.

Each CAC Member State will point out and submit to the competent committee any new scientific (or of any other sort) information that may warrant a revision of current Codex standards or related texts.
Represented by the National Institute of Food (INAL), ANMAT participates in the following committees:

• CCEXEC Executive Committee of the Codex Alimentarius Commission
• CCLAC FAO/WHO Coordinating Committee for Latin America and the Caribbean
• CAC Codex Alimentarius Commission
• CCCF Codex Committee on Contaminants in Foods
• CCFA Codex Committee on Food Additives
• CCFH Codex Committee on Food Hygiene
• CCFICS Codex Committee on Food Import and Export Inspection and Certification Systems
• CCFL Codex Committee on Food Labelling
• CCGP Codex Committee on General Principles
• CCMAS Codex Committee on Methods of Analysis and Sampling
• CCNFSDU Codex Committee on Nutrition and Foods for Special Dietary Uses
• CCPR Codex Committee on Pesticide Residues
• CCRVDF Codex Committee on Residues of Veterinary Drugs in Foods
• CCFFV Codex Committee on Fresh Fruits and Vegetables
• CCFO Codex Committee on Fats and Oils
• CCSCH Codex Committee on Spices and Culinary Herbs

The Global Coalition for Regulatory Science Research (GCRSR) was established in 2013 to foster the adoption of emerging technologies through the participation of regulatory authorities. Its objective is to facilitate education, scientific training and information exchange in the regulatory science sphere.

Since 2013, ANMAT has taken part in the Executive Committee of the Coalition, along with Brazil, the United States of America, Canada, Singapore, Australia, the United Kingdom, Japan, Korea and Italy.

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• GSRS: Global Summit on Regulatory Science

  The Global Summit on Regulatory Science (GSRS) is an annual international conference for the discussion about innovative technologies and for the development of science-based health regulatory capacities.

  It gathers scientists from government, industry and academia spheres to discuss and evaluate the usefulness of technologies, with a focus on their benefit for public health

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The International Cooperation on Cosmetics Regulation is an international group of cosmetics regulatory authorities comprised of Brazil, Canada, South Korea, the United States of America, Japan, the European Union and Taiwan.

This group of regulatory authorities gathers on an annual basis to discuss common topics related to cosmetics safety and regulation, as well as to strengthen a constructive dialogue with the industry commercial associations.

ANMAT has participated as an Observer Member since May 2017.

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) gathers regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals, as well as to develop ICH guidelines.

Since its establishment in 1990, ICH has gradually evolved to respond to the increasingly global developments in the pharmaceutical sectors and these ICH guidelines are implemented by an increasing number of regulatory authorities.

At present, ANMAT participates in the following working groups:

• Q1/Q5 - Targeted Revisions of the ICH Stability Guidelines Series
• Q3C (R9) - Maintenance of the Guideline for Residual Solvents
• E20 - Adaptative Clinical Trials
• M1 (PTC) - MeDRA Points to Consider
• CGTDG - Cell and Gene Therapies Discussion Group

ANMAT has been a Regulatory Member since 2024.

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ICMRA is a forum comprised of regulatory authorities engaged in providing strategic leadership to address regulations and the safety of current and emerging human medicine, in the face of new world challenges. Its objective is to facilitate cooperation among the heads of the health agencies across the world, offering them the possibility of exerting a collective and strategic mandate.

The Executive Committee is currently comprised of the European Medicines Agency (EMA), the Therapeutic Goods Administration (TGA) of Australia, the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, the National Health Surveillance Agency of Brazil (ANVISA), the US Food and Drug Administration (FDA), the Health Products and Food Branch Health Canada (HPFB-HC), the Health Products Regulatory Authority (HPRA) of Ireland and the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom.

The National Administration of Drugs, Food and Medical Devices (ANMAT) has been an Associate Member since March 2021.

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The International Medical Devices Regulators Forum (IMDRF) is a group of medical devices regulators across the world, who joined efforts to work on the basis of the work done by the Global Harmonization Task Force (GHTF) and aims at accelerating medical devices regulatory harmonization and convergence.

The IMDRF was established in October 2011, when representatives of medical devices regulatory authorities from Australia, Brazil, Canada, China, the European Union, Japan and the United States of America, as well as the World Health Organization met in Ottawa to address the establishment and operation of this new forum.

At present, ANMAT participates in the following working groups:

• Quality Management Systems
• Personalized Medical Devices
• Artificial Intelligence Medical Devices (AIMD)
• Good Regulatory Review Practices
• Software as a Medical Device

Furthermore, ANMAT participated in the following closed working groups:

• Medical Device Cybersecurity Guide
• Medical Device Clinical Evaluation
• Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

ANMAT has been an Official Observer to the IMDRF since August 2021.

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The International Pharmaceutical Regulators Program (IPRP) was established as a result of the consolidation of the International Pharmaceutical Regulators Forum (IPRF) and the International Generic Drug Regulators Program (IGDRP).

The IPRP purpose is to create an environment for its regulatory and observer members to exchange information about topics of mutual interest, to cooperate and promote the convergence of regulatory approaches to pharmaceutical products of human use.

As a member of this program, ANMAT participates in the following working groups:

• Nanomedicines Working Group (NWG)
• Bioequivalence Working Group for Generics (BEWGG)
• Quality for Generics Working Group (QWG)
• Pharmacovigilance Working Group (PVWG)

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The Medical Devices Single Audit Program allows a medical device manufacturer to undergo one single audit on its quality management system, which is conducted by an auditing organization recognized by the MDSAP and comprises all the requirements established by the participating regulatory authorities. The Program was developed as a result of joint work within the International Medical Devices Regulators Forum (IMDRF).

ANMAT has been an Affiliate Member of this Program since January 2020.

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The Southern Cone Common Market is a regional integration process established on March 26, 1991, by the Asunción Treaty. It was originally comprised of the Argentine Republic, the Federative Republic of Brazil, the Republic of Paraguay and the Oriental Republic of Uruguay. Later on, it was joined by the Bolivarian Republic of Venezuela (currently suspended) and the Plurinational State of Bolivia, which is currently undergoing the accession process.

The main objective of the Asunción Treaty is the integration of its Member States through the free circulation of goods, services and productive factors; the establishment of a common external tariff and the adoption of a common trade policy; the coordination of macroeconomic and sectoral policies and the harmonization of legislations in relevant areas. In December 1994, a protocol additional to the Asunción Treaty was approved, the Ouro Preto Protocol, whereby MERCOSUR institutional structure was established and it was granted an international legal personality. Ouro Preto Protocol put an end to the transition period and sparked the adoption of fundamental instruments for common trade policies that characterize the Customs Union. Therefore, Member States set out to start a new stage, with a view to reaching one single market that creates a greater economic growth through the leverage of productive specialization, scale economies, trade complementation and an enlarged negotiating power of the bloc with other blocs or countries.

Member States share a communion of values expressed in their democratic and pluralistic societies, which stand up for fundamental freedoms, human rights, environment protection and sustainable development. They also share their commitment to democracy consolidation, legal certainty, fight against poverty and economic and social development on an equity basis.

ANMAT takes part in the following sub-working groups:

• SGT N° 3 – Technical Rulings and Conformity Assessment
• SGT N° 11 – Health. Committee of Healthcare Products – COPROSAL

The World Health Organization is the directive and coordinating authority for international health affairs within the United Nations system.

WHO coordinates the international health task by promoting collaboration through the mobilization of alliances and various agents within the health sphere.

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• ICDRA - International Conference on Drug Regulatory Authorities:

  The International Conference on Drug Regulatory Authorities (ICDRA) provides drug regulatory authorities of WHO Member States with a space to meet and discuss ways for collaboration strengthening. ICDRA fora have been central in guiding regulatory authorities, WHO and stakeholders, as well as to determine action priorities in the national and international regulation of drugs, vaccines, biomedicines and herbals.

• IRCH - International Regulatory Cooperation for Herbal Medicines:

  The International Regulatory Cooperation for Herbal Medicines (IRCH) is a global network of regulatory authorities responsible for the regulation of herbal medicines.

  Established in 2006, it holds the mission of protecting and promoting public health and safety, through a better regulation of herbal medicines.

  ANMAT has been a member since August 2017.

The Pan American Health Organization is a healthcare-specialized body in the Inter-American system, which operates as a Regional Office of the Americas of the World Health Organization (WHO).
It provides technical cooperation and fosters associations for improved health and life quality in the countries of the Americas.

Along with WHO, PAHO is a member of the United Nations system.

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• PANDRH - Pan American Network for Drug Regulatory Harmonization:

  It is an initiative by the National Regulatory Authorities of the Region and the Pan American Health Organization, that supports processes of pharmaceutical regulatory harmonization in the Americas within the framework of national and subregional health realities and policies, as well as the recognition of existent asymmetries.

  During the VIII Conference of the Pan American Network for Drug Regulatory Harmonization, the mandates of its Steering Committee members were renewed. Argentina was appointed to represent the Southern Cone region for the next biennium.

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• Regional Network of Substandard and Falsified Medical Products:

  Within PAHO working lines is the Regional Network of Substandard and Falsified Medical Products, which aims at fostering information exchange about the actions performed and the progress attained under national action programs and plans for the prevention of substandard and falsified products to boost communication and collaboration among countries.

  ANMAT has coordinated this initiative since February 2022.

It is a non-binding agreement among National Regulatory Authorities in the sphere of Good Manufacturing Practices of pharmaceutical products for human and veterinary use. Currently, 56 Regulatory Authorities participate in this initiative.

PIC/S aims at harmonizing inspection procedures through the development of standards in the framework of GMP and training inspectors.

Since 2008, ANMAT´s Good Manufacturing Practices Inspectorate has been a PIC/S full member.

Also, ANMAT participates in 3 sub-committees:

SCT Training
SCSD (Strategic Development)
SCEC (Expert Circles)

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This network holds the main objective of consolidating a network of health authorities with technical, scientific and regulatory excellence in the sphere of medicines and healthcare products, which allows for improved quality and efficiency of its members and serves as a reference for professionals and citizens.

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