Mexico Strengthens Health Security: The Transition from the CNFV to the New CENAFyT
Mexico has taken a decisive step in modernizing its healthcare system with the creation of the National Center for Pharmacovigilance and Technovigilance (CENAFyT). Integrated into the General Health Law, this new body expands supervisory powers over both medicines and medical equipment, ensuring greater protection for all citizens.
Navigating the Regulatory Red Tape: The Crucial Role of Regulatory Affairs for Health Products and Medicines
This blog post dives into the indispensable role of Regulatory Affairs in bringing health products and medicines safely to market and ensuring their ongoing compliance. It explores the critical processes of product registration and post-market surveillance (pharmacovigilance/technovigilance), highlighting why mandatory reporting of serious and unexpected adverse events is crucial, even when initial causality assessments are “not related.” Ultimately, the article emphasizes how expert regulatory teams, like GRP Brazil, are essential partners in navigating complex regulations to ensure patient safety and business success.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Anvisa publishes new Technovigilance Manual 2021
The new Technovigilance Manual improves health regulation to meet the challenges posed by new technologies and the speed with which reality is changing.