Publication of the Regulatory Equivalence Agreement for Medications between the COFEPRIS and the ANVISA of Brazil

September 17, 2026

On September 2, 2026, the Agreement establishing General Guidelines for the application of the expedited regulatory process that grants health registrations for medications where there is equivalence of requirements, trials, and evaluation procedures as issued by the National Health Surveillance Agency of the Federal Republic of Brazil (ANVISA) was published in the Official Gazette of the Federation (DOF) and signed by the Secretary of Health, David Kershenobich Stalnikowitz. 

This new Agreement establishes a specific expedited regulatory pathway that recognizes equivalencies by the ANVISA within the framework of the regulatory reliance strategy promoted by the Federal Commission for Protection against Health Risks (COFEPRIS) since 2010. The World Health Organization (WHO) Prequalification Program had consolidated other Reference Regulatory Authorities as of July 2025. The most relevant aspects of this new rule are below:

1. Purpose and Legal Nature

The purpose of the Agreement is to enable the COFEPRIS to validate equivalencies to grant medication registrations in Mexico regarding the requirements, trials, and evaluation procedures that the ANVISA had already carried out, thus avoiding repetition of the technical analysis conducted by the Brazilian authority. 

Article 161 Bis of the Health Supplies Regulation and Article 222 of the General Health Law form the legal basis of the Agreement, which allow the Secretary of Health to recognize certifications and evaluations from a country of origin when the competent authorities establish agreements of recognition. 

2. This does not imply automatic recognition

The Agreement explicitly states that the COFEPRIS retains authoritative responsibility and administrative, technical, and operational autonomy. There is no automatic recognition for medications authorized in Brazil. Rather, the expedited process is only for specific applications that must meet the technical, legal, and documentary requirements established in Mexican regulations.

3. Eligible Applicants and Medications

Applications for medications falling into the following categories may be submitted through this process: 

• Drugs containing new molecules. 

• Generic drugs. 

• Innovative biotechnology drugs. 

• Bioequivalent biotechnological drugs. 

• Biological products and vaccines. 

A product belonging to any of these categories does not automatically qualify it for the expedited pathway. Any medication submitted for authorization in Mexico must have essentially identical, basic characteristics of the product authorized by the ANVISA. Such equivalence must be demonstrated, and the Brazilian authorization must be valid at the time a Mexican application is submitted.

4. Procedural Requirements

Applications must be filed under reference number COFEPRIS-04-040 (Application for Medication Registration based on Equivalent Reference Regulatory Authority). The application file must be submitted in CTD format (Common Technical Document) in accordance with the guidelines of the International Council for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). 

For chemically synthesized drugs and additives, Module 3 of the CTD may reference the most recent version of the Brazilian CADIFA, which reduces the documentation burden. Additionally, a Good Manufacturing Practices (GMP) certificate is required for the manufacturer of a drug, biopharmaceutical, antigen and, where applicable, a chemically synthesized drug.

5. Excluded ANVISA Authorizations

The expedited pathway must be based on standard ANVISA authorizations. The following are expressly excluded from Mexican application: 

• Evaluations obtained from the ANVISA through reliance mechanisms. 

• Conditional authorzations. 

• Emergency authorizations. 

• Authorizations obtained by court order. 

• Any scheme other than standard approvals when the evaluation is deemed insufficient to demonstrate quality, safety, and efficacy. 

Any differences regarding quality, manufacturing sites, or primary packaging in comparison to the ANVISA approval will require applications to go through the standard process set forth in the Health Supplies Regulation. Flexibility is allowed for secondary packaging sites that are different from those approved by the Brazilian authority, provided that corresponding legal documentation is submitted.

6. Decision Deadlines and Powers of the COFEPRIS

The COFEPRIS will have a maximum of 45 business days to issue a decision. This timeframe refers to the issuance of a decision and does not constitute an automatic approval merely because the deadline has expired. 

The COFEPRIS is limited to verifying that the required documentation is complete and has properly been submitted, without further examining the elements already evaluated by the ANVISA, at this time. The Mexican authority retains the power, however, to verify the authenticity of the documentation, confirm that the products correspond to the those approved by Brazil, exercise health surveillance, receive pharmacovigilance reports, and revoke the registration when grounds are met as established in the Mexican legislation.

7. Entry into Force and Transitory Articles

• The Agreement enters into force 30 business days after its publication in the DOF, approximately mid-October of 2026. At this time, the COFEPRIS must publish a corresponding official form on its website. 

• Health registration applications submitted prior to the Agreement’s entry into force and that are pending a decision must proceed in accordance with the provisions in effect at the time of submission.

8. Context of Bilateral Cooperation

This Agreement is part of broader regulatory cooperation between Mexico and Brazil. In August 2025, the COFEPRIS and the ANVISA signed a new Memorandum of Understanding during the official Mexican visit of Brazil’s Vice President, Geraldo Alckmin. Cooperation regarding regulatory reliance and the exchange of information was expanded through this Memorandum. 

As a precursor to this cooperation, the COFEPRIS had already recognized the ANVISA as a Reference Regulatory Authority for expedited health registrations of medical devices and valid Certificates of Good Manufacturing Practices (CBPF) for pharmaceuticals, drugs, and medical devices. The ANVISA, in turn, recognized the COFEPRIS as an Equivalent Foreign Regulatory Authority regarding Certificates of Good Manufacturing Practices for pharmaceuticals. 

The Regulatory team at Arochi & Lindner is at your service to address any questions, conduct impact analyses, or receive feedback regarding the publication and implementation of this Agreement with regard to the assessment of your products’ eligibility for the expedited pathway, the compilation of a CTD file, and any other applications before the COFEPRIS. Please do not hesitate to contact us.