Whitepaper: Medicinal Cannabis Products – Regulatory differences between Brazilian and Mexican Legislations

We have published our new Whitepaper that describes the main differences between Mexican and [...]

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DIGEMID (Peru) – New measures to guarantee the availability of medicinal products to the population

On December 5, 2019, the Supreme Decree (SD) 026-2019-SA was published in the Official Gazette, [...]

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COFEPRIS – Recognition of Marketing Authorizations from Reference Authorities – updated 18th March

On January 28, 2020, an Agreement from the Mexican Comisión Federal para la Protección Contra [...]

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Nitrosamine Medicinal Products Contamination – Scenario in Europe, United States, and Latin America – updated on August 8, 2022

In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in several [...]

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Importation procedures in Mexico – Mexican Foreign Trade Receipt System (Ventanilla Única de Comercio Exterior Mexicano – VUCEM)

The Mexican Foreign Trade Receipt System (VUCEM) is an integral service platform that [...]

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cGMP requirements for Latin American drug products MA submissions – updated 18th May 2021

A marketing authorization submission represents a major effort for the pharmaceutical industry, [...]

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Latin America – Regulatory Agencies

Latin America is increasingly raising interest from pharmaceutical companies in other regions. [...]

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