VigiFlow eReporting for Industry

VigiFlow eReporting for Industry is an add-on module for the VigiFlow platform, developed by UMC, that enables national regulatory authorities to collect post-marketing and clinical trial safety reports from marketing authorisation holders (MAHs) in line with ICH guidelines. It is designed for regulatory agencies and industry associations in countries transitioning toward ICH membership, where paper or email-based reporting remains common and standardised electronic data exchange infrastructure is lacking.

Post-marketing safety reports from manufacturers are a key source of information for detecting adverse events related to medicines and vaccines. VigiFlow eReporting for Industry addresses the challenge that many regulatory authorities face in meeting ICH technical standards — specifically the requirement for E2B(R3)-compatible systems for exchanging safety data — by providing a ready-to-use, standardised submission channel for MAHs.

Key Features

• Off-the-shelf solution requiring no installation, with low implementation costs.
• Supports both manual data entry and ICH E2B-compliant XML file submissions, allowing MAHs to report regardless of whether their internal systems are ICH E2B compatible.
• Built-in WHODrug Global coding for medicines and vaccines and MedDRA coding for adverse events, removing the need for manual coding during data entry.
• Ensures all marketing authorisation holders can meet national regulatory reporting requirements based on ICH guidelines, even when their own databases are not compatible with those standards.
• Reduces manual data entry and coding burden on regulatory staff, allowing them to focus on data review and safety signal identification.

Reporting Workflow

• MAHs whose systems are not ICH E2B compatible can manually enter safety report data directly into the module, with built-in WHODrug and MedDRA coding applied during entry.
• MAHs with compatible systems can submit reports as ICH E2B XML files.
• Submitted data is collected by the national regulatory authority through VigiFlow, standardising the intake process across all submitters.
• Minimal implementation effort is required for MAHs to connect their systems to VigiFlow eReporting for Industry.

Regulatory Adoption and Compliance

• Supports ICH guidelines for both clinical trial and post-marketing safety data reporting.
• Helps companies meet national regulatory requirements and facilitates cross-border data sharing as more countries adopt ICH standards.
• Colombia's national regulatory agency, INVIMA, has required companies to submit safety data through VigiFlow eReporting for Industry since 2025, replacing a previous process in which safety reports received by email were manually entered into a non-ICH E2B-compliant system.

VigiFlow eReporting for Industry is available as a module within the VigiFlow data collection platform and is related to other UMC tools including WHODrug Global and VigiMobile. It is hosted without requiring local installation, making it accessible to regulatory authorities with limited technical infrastructure.