ISoP Africa Chapter Meeting
ISoP Africa Chapter Meeting IntuVigilance helped organise the first ISoP Africa Chapter conference in Uganda, attracting over 300 delegates, 40 speakers and 15 sponsors. Advancing Pharmacovigilance Practice in Africa: Moving from Data collection to Data Driven Decision Making. Share LinkedIn Related Articles Talk to us about building a more proactive PV operation.Get to know the […]
Brazil’s regulatory framework
Brazil’s regulatory framework News Brazil’s regulatory framework for drugs is undergoing significant modernization, with updates spanning clinical trials, drug registration, pricing, and post-marketing surveillance. Clinical Trials & Drug DevelopmentKey Regulations: Resolution RDC 945/2024: Governs clinical trials for drugs and biologics Law No. 14,874/2024: Requires ethical review by research ethics committees (CEPs) ICH Guidelines E6(R3): Adopted […]
Pharmacovigilance After the Windsor Framework
Pharmacovigilance After the Windsor Framework What MAHs Need to Know in 2025 The Windsor Framework, which came into effect on January 1, 2025, brings significant regulatory transformations to pharmacovigilance (PV) practices throughout the United Kingdom. In this new landscape, Great Britain (GB) adheres to the established UK PV legislation, while Northern Ireland (NI) remains committed […]
National Pharmaceutical Regulatory Agency (NPRA) of Malaysia
National Pharmaceutical Regulatory Agency (NPRA) of Malaysia National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published an updated version of the Guidelines for the Implementation of Drug Information Leaflets for Consumers (RiMUP), effective from 01 April 2025. Digital Submission via QUEST3+: Starting April 2025, all RiMUPs for evaluation by the Pharmacovigilance Section (PKKK) must be submitted […]
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 […]
Regulatory Intelligence & PV Expertise in AFRICA
Regulatory Intelligence & PV Expertise in AFRICA Our Pharmacovigilance (PV) Team in Africa brings a wealth of expertise in Regulatory Intelligence and Pharmacovigilance processes. With a deep understanding of both post-commercialized products and clinical trial legislation, our team is well-equipped to navigate the intricate regulatory landscapes across various countries in the African region. The varied […]
PV Expertise in MEXICO
PV Expertise in MEXICO Mandatory XML SubmissionAs part of the regulatory updates, it is important to note that the submission of adverse event reports in the XML (E2B) format will become mandatory for all pharmaceutical companies in Mexico. This shift underscores the need for companies to prepare for compliance with the new requirements. The implementation […]
Fireside chat with Dr Helen Byomire Ndagij, Uganda National Drug Authority
Fireside chat with Dr Helen Byomire Ndagij, Uganda National Drug Authority Dr Helen Byomire Ndagije is a pharmaco-epidemiologist with extensive international experience in drug regulation and a passion for health systems strengthening. Since 2006, she has led the Ugandan National Pharmacovigilance Centre, the first one with a decentralized system of pharmacovigilance in Africa.https://youtu.be/cThsd9o1bMI Share LinkedIn […]