Pharmacovigilance Services in Colombia

The Colombian National Food and Drug Surveillance Institute (INVIMA) is responsible for overseeing all regulatory and pharmacovigilance activities for pharmaceutical products that are in circulation in the country. Patient safety is the core of all pharmacovigilance activities where timely detection and management of ADRs is imperative in order to implement effective risk mitigation/minimization strategies. The INVIMA mandates all manufacturers and marketing authorization holders (MAHs) to report ADRs and any product-quality related issues to determine the safety profile of the pharmaceutical product. Colombia is actively working to improve their pharmacovigilance system by enhancing the quality and quantity of ADR reports by, for example, implementing electronic ADR/AE submission tools and expanding their National Pharmacovigilance Network. As a result, a significant increase was seen in the number of reported ADRs and originated from a variety of regions within Colombia. However there are still important pharmacovigilance parameters that require proactivity to ensure patient safety. This includes better ADR analysis methods and simplifying ADR reporting procedures to make them more user friendly thereby encouraging all relevant stakeholders to report ADRs to strengthen post-market surveillance.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Colombia that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.