Mexico streamlines regulatory process for Brazilian medicines

Mexico has established new guidelines to facilitate the entry of Brazilian medicines into its national market. Under the new regulations, the Mexican sanitary authority, Cofepris, will recognize decisions made by Brazil’s Anvisa, aiming to process the entry of products within a maximum of 45 business days.

The measure covers a wide range of products, including new molecules, generics, biotechnological products, biocomparables, biological products, and vaccines. This regulatory shift is intended to prevent the duplication of processes by leveraging existing evaluations from the Brazilian agency.

While the move strengthens bilateral health cooperation following recent diplomatic visits, Mexican pharmaceutical companies have expressed concerns regarding reciprocity. Industry representatives noted that Brazil has not yet implemented similar measures to facilitate the entry of Mexican medicinal products into its own market.