WHODrug Global in VigiFlow eReporting for Industry
Use WHODrug Global to submit ICSRs to COFEPRIS, Mexico, with VigiFlow eReporting for Industry
Lea sobre ello en españolThe Federal Commission for Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) requires the pharmaceutical industry in Mexico to submit suspected adverse drug reactions via the UMC-hosted VigiFlow eReporting for Industry. Since March 2022, the platform supports medical coding, including drug coding via WHODrug Global, and enables full compliance with established and future-proofed standards.
What is WHODrug Global?
WHODrug Global, developed and maintained by Uppsala Monitoring Centre (UMC) is an international reference for medicinal product (including vaccine) information and the most actively-used drug reference dictionary in the world today. WHODrug Global effectively facilitates the exchange of medicinal product information.
With its unique drug code hierarchy and extensive coverage, WHODrug Global provides a consistent drug dictionary with exact terminology when coding medications. The dictionary is used to identify drug names and evaluate medicinal product information, including active ingredients and product classification, from over 150 countries. WHODrug Global is available within VigiFlow eReporting for Industry, so that the pharmaceutical industry in Mexico may submit structured drug information for suspected adverse drug reactions to the Mexican authority.
WHODrug Global in VigiFlow eReporting for Industry
Drug coding with WHODrug Global is now available in VigiFlow eReporting for Industry to support COFEPRIS in their analysis capacity, as well as to enable the exchange of medicinal product information in a standardised, structured and globally accepted format between the industry and regulators. Reports to be submitted to COFEPRIS can be entered and coded manually or uploaded in XML format. Read more in a statement from COFEPRIS below (available in Spanish only).
Access VigiFlow eReporting for Industry
To be able to report to COFEPRIS via VigiFlow eReporting for Industry, pharmaceutical companies are requested to contact COFEPRIS via email, xmlvigiflow@cofepris.gob.mx. Read more below (available in Spanish only).
How to get access to WHODrug coding in VigiFlow eReporting for Industry
Manual data entry
- Currently, basic drug coding functionality with WHODrug Global is available to all manual data entry users of Industry eReporting
- In the future, a more refined solution for manual drug coding is planned for the VigiFlow eReporting for Industry platform. With the rollout of this new functionality, a WHODrug license will be required for all users and the basic coding functionality will be phased out. More information about licensing and options available will follow.
XML uploads
- XML-uploads with data structured with WHODrug Global (e.g. from commercially available pharmacovigilance platforms) is supported. To access WHODrug Global within your pharmacovigilance platform, a WHODrug license is required. To ensure timely access, organisations using a pharmacovigilance platform without current support for coding with WHODrug Global are encouraged to request the vendor to get in touch with UMC as soon as possible for licensing and implementation support.
WHODrug training and support
Organisations with a valid license for WHODrug Global can access web-based training courses, webinars, supportive documentation and more via the WHODrug User Area, available through the UMC website (login credentials required).
For any questions related to training and content support for WHODrug Global, please contact our dedicated support team via email.
In addition, UMC is also planning to offer specific support to the Mexican pharmaceutical industry. More information will follow.