Elevating Clinical Pharmacology Standards in Argentina

Elevating Clinical Pharmacology Standards in Argentina On June 24, 2025, Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) officially adopted three key guidelines from the International Council for Harmonisation (ICH)—E2A, E2F, and E3—through its new regulation (ANMAT Disposition 4385/2025). What this means: ICH E2A (Clinical Safety Data Management): Establishes clear definitions and standards for […]

Updates to Colombian Pharmacovigilance Regulation

Updates to Colombian Pharmacovigilance Regulation News Colombia’s pharmacovigilance system for medications has historically been guided by Decree 2200 of 2005. The latest regulation concerning pharmacovigilance in Colombia is Resolution 2024015321 of 2024, which outlines the framework for the National Pharmacovigilance System (SNFV). This resolution sets forth the requirements for pharmacovigilance officers, introduces a risk-based classification […]

The Thai Food and Drug Administration (TFDA)

The Thai Food and Drug Administration (TFDA) News Are you in need of the most recent regulations regarding post-marketing and clinical trials in Thailand? Thailand has recently updated its pharmacovigilance framework to align more closely with international standards and enhance drug safety monitoring. The Thai Food and Drug Administration (TFDA), has introduced several new guidelines […]

IntuVigilance has established a presence in China

IntuVigilance has established a presence in China If you are looking to navigate the complex regulatory environment in China, particularly concerning the reporting requirements for clinical trials and post-authorization processes, IntuVigilance is here to assist you. We are excited to announce that IntuVigilance has established a presence in China, offering comprehensive regulatory affairs and drug […]