😎 Hemos creado el subgrupo LATAM

[Naiffer_Host]

Por aquí los invito a revisar este sumario de eventos y desarrollos regulatorios que han ocurrido en nuestra región. Los invito a agregar cualquier información que sea de su conocimiento. El mismo incluye Brasil, Chile, Perú, Cuba, Argentina, México, Colombia, Ecuador, Costa Rica, Panamá, El Salvador y Honduras

Fantastic Regulatory Update Europe, US, LATAM

I came across this fantastic summary of Nitrosamines Impurities update considering scenarios in Europe, USA, and LATAMN -Full credit to folks from Vita Pharma Consulting In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in several blood pressure medicinal products, known as sartans (angiotensin receptor blockers – ARBs). This led to some product recalls and a regulatory review, which set new strict manufacturing requirements for these medicinal products. Sub…