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Safety reporting in LATAM is changing, are you ready?

LATAM is evolving to electronic safety reporting. At this point it looks like there will be some common systems across countries and one of these is VigiFlow.

In Brazil ANVISA (Agência Nacional de Vigilância Sanitária) has committed to implementing all Tier 2 guidance in 2021 and recently announced they will be validating, through a pilot test process, a module in Vigiflow designed for pharmaceutical companies, which is available from October 2020.

Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) has also gone down the route of conducting a pilot phase called “Industry eReporting” which aims to replace the use of current eReporting for the pharmaceutical industry and CROs. 

Argentina’s ANMAT, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica has not yet indicated when it will move  towards ICH E2B, but it anticipated that it will follow shortly.

However the first country that is already in the process of introducing VigiFlow is Colombia, and it will serve as a learning opportunity for deployment in other countries. Colombia’s INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia National Food and Drug Surveillance Institute) was recognised as an ICH (International Council for Harmonisation) regulatory observer at the end of last year. Since then Colombia has complied with ICH standards along with its country regulatory guidance.  The latest update came in form of the Tier 2 guidance ICH E2B: Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports. In order to achieve this ICH E2B change in Colombia, INVIMA has identified the need to design, plan and purchase a technological solution for the implementation of this guidance. In 2019, INVIMA collaborated with UMC in Uppsala, Sweden on VigiFlow, which is compliant with the international ICH E2B standard. The pilot testing phase is currently open and the authority will mandate E2B submission from Quarter 4, 2020.

Access to VigiFlow is strictly controlled via a licensing fee, however, a country-specific bolt-on system can be developed as an interface to the system. Uppsala Monitoring Committee (UMC) confirmed that there will be two different platforms for report submission for INVIMA safety reporting; one for those companies that are not able to generate E2B XML’s from their safety databases, i.e. mainly smaller companies or investigational sites. This will be a manual, time consuming process for safety information upload that might require additional planning to ensure data quality.  A second platform will be available for all other companies for manual uploading of E2B XML’s reports/files, in a more streamlined manner.

Looking at the second option here, XML files are key to a streamlined ICH E2B process and configuration of the company safety database is required to meet the data exchange requirements for ICH E2B R2 and R3. Depending on the country specific interface system, it may allow for direct upload, or upload with manual data entered for particular fields that can support any language specific requirements such as narratives. This last requirement, may entail the need for certified translations and system adjustments.

INVIMA announced that it expected that all companies should have performed all the changes and updates in systems to generate the XML files in English for the initial testing by 13 April 2020. INVIMA then had a second testing phase for submission of XMLs with the verbatim event term and narrative in Spanish.

The ICON pharmacovigilance team was selected to participate in the pilot testing with INVIMA and accordingly our team was able to proactively test with the latest version of the Argus safety database.  The ICON team included skilled systems experts and a cross-functional Spanish speaking team based in Mexico and Colombia.  We successfully completed testing with INVIMA in both R2 and R3 XML submissions (in English and Spanish) and will continue to participate in the subsequent pilot phases until E2B implementation in Colombia.

The complex nature of regulatory safety reporting requirements demands a high level of expertise, instant access to critical regulatory intelligence and may require lengthy programming and set-up to ensure compliance. ICON’s dedicated pharmacovigilance intelligence team was established over a decade ago, and specialises in the evaluation of safety reporting requirements through daily review of local, regional and country specific regulatory intelligence and has direct, established contact with regulatory authorities.

ICON’s Miriam Zavaleta will be speaking about the imminent changes at the 1er Congreso Latinoamericano de Farmacovigilancia y Tecnovigilancia y XIV Congreso Nacional de Farmacovigilancia y Tecnovigilancia Congress.

For more information on getting ready for the safety reporting changes in LATAM please contact our pharmacovigilance team.

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