Your direct channel for post-licensing safety reporting

VigiFlow eReporting for Industry makes it faster and easier for regulatory authorities to collect fully ICH-compliant post-marketing and clinical trial safety reports from marketing authorisation holders.

Processing data in Conakry, Guinea. Photo: WHO/Sean Hawkey
Processing data in Conakry, Guinea. Photo: WHO/Sean Hawkey

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One important source of information on suspected side effects from medicines is the safety reports that come in from manufacturers once their product is on the market. Getting that data quickly is key to making sure safety issues are detected early.

In many countries paper or email reporting is still the rule due to a lack of common infrastructure for exchanging data electronically. This is a challenge, especially for countries looking to strengthen their regulatory systems and meet the technical requirements for membership of the International Council for Harmonisation (ICH). Under ICH guidelines it is mandatory for countries to have systems in place that are compatible with ICH E2B(R3) – the international format for exchanging information on the suspected side effects of medicines. 

As more and more countries apply for ICH membership, VigiFlow is evolving in step with quality guidelines. VigiFlow eReporting for Industry is an add-on module to VigiFlow that makes it easier for you to get the data you need, how you want it. It increases the quantity and quality of information regulatory authorities receive by helping companies to report in a standardised way, saving you time on manual data entry and coding to WHODrug Global and MedDRA.

VigiFlow eForms

Our digital reporting forms for patients and health workers boost the quality and quantity of data national centres receive by making it easier for reporters to collect information on suspected side effects to medicines and vaccines.

Companies whose systems are not ICH E2B-compliant can use manual data entry to code medicines and vaccines in WHODrug as well as adverse events in MedDRA.
Companies whose systems are not ICH E2B-compliant can use manual data entry to code medicines and vaccines in WHODrug as well as adverse events in MedDRA.

Key features 

  • Off-the-shelf solution – low implementation costs and no installation necessary. 
  • With VigiFlow eReporting for Industry all marketing authorisation holders can achieve compliance with ICH guidelines, regardless of whether their databases are ICH compatible. 
  • Marketing authorisation holders report directly to you using manual data entry or ICH-compliant E2B xml files. 
  • Built-in WHODrug and MedDRA coding support eliminates the need for manual coding and data entry, freeing up resources for analysis. 
  • Moving coding to marketing authorisation holders increases the accuracy of the information you receive, reducing the risk of errors and removing the need for cross-checking. 

Got a licence? 

VigiFlow eReporting for Industry comes at an additional cost to VigiFlow. Contact us to find out how you can get started at 

Mexico and Brazil have already made coding to MedDRA in manual data entry mandatory for industry submissions. Announcing the change, Brazil’s regulatory authority Anvisa said this would help them “to obtain higher quality information for analysis and decision-making regarding the benefit-risk profile of medicinal products”.

Removing your burden of coding frees up more resources for signal detection and speeds up decision-making.

Marketing authorisation holders, meanwhile, benefit from streamlined processes and improved workflows. Minimal implementation is required for them to integrate VigiFlow eReporting for Industry with their own systems so that safety reports comply with the ICH guidelines.

This not only helps them to follow the specific regulatory requirements for reporting in their own country but also simplifies data sharing across borders as more countries make the ICH guidelines mandatory. 

Last modified on: October 13, 2023