Categories:
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 [...]
Ler mais
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, [...]
Ler mais
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 [...]
Ler mais
Nitrosamine Medicinal Products Contamination – Scenario in Europe, United States, and Latin America – updated on July 19, 2023
In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in several [...]
Ler mais
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 [...]
Ler mais
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, [...]
Ler mais
Latin America – Regulatory Agencies
Latin America is increasingly raising interest from pharmaceutical companies in other regions. [...]
Ler mais