On September 15, 2025, the Instituto de Salud Pública de Chile (ISP) announced the implementation of the World Health Organization’s (WHO) international pharmacovigilance standard to enhance the safety monitoring of medicines and vaccines in Chile.
🔍 What Is the WHO Standard?
The WHO standard, known as E2E, is a global framework for the collection, assessment, and reporting of adverse drug reactions (ADRs). It ensures that all stakeholders—healthcare providers, regulatory authorities, and pharmaceutical companies—follow consistent procedures for detecting and evaluating the safety of medical products.
❗ Why Is This Important for Chile?
By adopting the E2E standard, Chile aligns its pharmacovigilance practices with international best practices, enhancing the country’s ability to detect and respond to potential safety issues with medicines and vaccines. This move underscores Chile’s commitment to protecting public health and ensuring the safety and efficacy of medical products available in the country.
🛡️ What Does This Mean for Stakeholders?
Healthcare Providers: Will be required to report ADRs using standardized formats, facilitating more efficient data collection and analysis.
Pharmaceutical Companies: Must adhere to the new reporting requirements and ensure that their products are continuously monitored for safety.
Regulatory Authorities: Will have improved tools for assessing and responding to safety signals, leading to more informed decision-making.
📅 Looking Ahead
The ISP plans to provide training and resources to support the transition to the new standard, ensuring that all stakeholders are equipped to comply with the updated pharmacovigilance requirements. This initiative represents a significant step forward in enhancing the safety and effectiveness of medical products in Chile.
🌐 How LAMA Keeps You Up-to-Date
At LAMA, we understand that regulatory landscapes in Latin America are constantly evolving. From new pharmacovigilance standards in Chile to fast-track approval pathways in Mexico or evolving GMP enforcement in Argentina, keeping track of changes is critical for successful market access.
Our team of local and regional experts monitors updates across every country in the region, translating complex regulatory news into actionable insights. We ensure that your business stays compliant, anticipates changes, and can make informed decisions with confidence.
With LAMA, you’re never navigating Latin American regulations alone—our expertise helps you stay ahead in a dynamic market.
See the full ISP annoucment here: https://www.ispch.cl/noticia/isp-implementa-estandar-internacional-de-la-oms-para-fortalecer-la-farmacovigilancia-en-chile/