On 23 April 2024, Cofepris released notification related to the implementation plan of WHODrug and MedDRA as coding standards in Pharmacovigilance.
As per the notification, as of January 1, 2024, it is required that the holders of health records and their legal representatives, distributors/marketers, as well as institutions or establishments where health research is carried out, encode medicines and vaccines with WHODrug in the notification of EA, SRAM, RAM, ESAVI, as well as any other safety problem derived from its use, this applicable in the pre-marketing phase as in post-commercialisation, in accordance with the requirements established in the WHODrug Implementation Plan published in December 2022.
The statement includes the following updates in terms of implementation of WHODrug and MedDRA for the Pharmaceutical Industry that have as their goal, to support compliance with the previously established requirements:
- In the month of April 2024, the UMC will carry out updates to the e-Reporting Industry interface that will consist of the following:
- The basic coding of WHODrug (manual loading) will no longer be available for use and will be replaced by the coding in WHODrug C3 format.
- It will be necessary for the users of each organization (applies to both modules) to enable their corresponding MedDRA and WHODrug licenses in the “License Management” section of e-Reporting Industry to be able to use the tool and send the notifications to the National Pharmacovigilance Center (CNFV).
Each National Regulatory Authority will determine the activation of the update implemented by the UMC, so for Mexico this function will be enabled by the CNFV on July 1, 2024.
- The users of the E2B load module, in accordance with the implementation plan, should have completed the configuration tests of their XML for C3 encoding with the CNFV and the Uppsala Monitoring Center (UMC), to receive approval for the start of production.
- Notifications of follow-up of initial cases reported before January 1, 2024, must be entered in e-Reporting Industry with the MedDRA and WHODrug encoding.
- Organizations that use e-Reporting Industry (for both modules) that submitted notifications since January 1, 2024 without the MedDRA and WHODrug encryption, must generate the respective follow-up reports to include both terminologies in these cases. The above, so that these notifications are valid for the CNFV and can be integrated into the national database and subsequently sent to the WHO database.
Finally, with the intention of maintaining the quality of the information in WHODrug and the periodic update of it, it is recalled that each health registry holder or legal representative in Mexico user of this terminology, must carry out the usual review of the products of his company in WHODrug in order to request the registration and update of missing or equivocal medicines and vaccines through the WHODrug Change Request tool (individual modifications) or through the attached Excel template and with sending to the email WHODrug@who-umc.org (for batch modifications) in accordance with the Implementation Plan. The above also applies to molecules under investigation for the reporting of adverse events in the pre-marketing phase.
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