Among the topics discussed was the strengthening of cooperation between Anvisa and Cofepris, with a focus on adopting mechanisms to expedite the marketing authorization of medicinal products in Mexico based on technical assessments conducted by the Brazilian regulatory authority.

At the unilateral initiative of the Mexican authority, the arrangement establishes an expedited regulatory pathway based on Anvisa’s assessments and regulatory decisions. Under this framework, the Mexican authority would recognize as equivalent certain requirements, tests, and assessment procedures performed by the Brazilian health authority during the marketing authorization process for medicinal products, thereby enabling products already assessed and approved by Anvisa to undergo a more streamlined process for obtaining marketing authorization in Mexico.

The measure covers innovative medicinal products, generic medicines, innovative biotechnology products, biosimilars, as well as biological products and vaccines. To qualify for this pathway, the product submitted to the Mexican regulatory authority must have the same essential characteristics as those authorized by Anvisa, and the corresponding Brazilian marketing authorization must remain valid and in force. The required legal, technical, and scientific documentation must also be submitted to the Mexican authority.

The parties also discussed the possibility of launching a call for applications for the submission of marketing authorization requests by Brazilian and Mexican pharmaceutical companies, with joint assessments to be conducted by Anvisa and Cofepris. The initiative aims to promote the exchange of knowledge and experience between technical teams, enhance understanding of each country’s regulatory processes, and strengthen mutual confidence between the authorities.

The proposed joint assessment framework represents another significant step toward strengthening cooperation between Anvisa and Cofepris and may contribute to the consolidation of regulatory reliance mechanisms, further enhancing integration among health regulatory authorities across the region.

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