Brazil's WHODrug and MedDRA: Key Tools in the New Era of Pharmacovigilance

The recent update from Brazil’s National Health Surveillance Agency (ANVISA) introduces significant changes to pharmaceutical reporting requirements. A new Collegiate Directive Resolution (RDC) revises the previous RDC No. 406 from July 22, 2020. This updated resolution mandates pharmaceutical companies to use the WHODrug dictionary when coding suspected adverse event reports through the VigiMed system, alongside adhering to the E2B (R3) format set by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Companies are given one year to align their practices with these new requirements. WHODrug, a globally recognized reference dictionary for medicines and vaccines, plays a pivotal role in this transition, supporting the implementation of ISO IDMP drug identification standards, as outlined in ICH Guidelines. Importantly, this change does not affect the current methods for notifying users and healthcare professionals about adverse events but reinforces the accuracy and consistency of the data reported.

**WHY? **

The new WHO regulations have a significant impact as they affect all pharmaceutical companies operating in the 180 countries participating in the WHO International Program. This implies widespread adoption of international standards, which can improve the quality and consistency of pharmacovigilance data worldwide.

Mandatory use of WHODrug and MedDRA for adverse event coding facilitates the aggregation of national and global information on the same drugs and suspected adverse events. This improves the identification of safety signals, which can lead to faster detection of problems and a more effective response to protect public health.

Companies have a one-year period to adapt to these changes, which requires an investment in training and system updates. This can represent a significant challenge, especially for smaller companies or those with fewer resources.

The collaboration between ANVISA and the Uppsala Monitoring Center (UMC) to provide training and technical support ensures that companies have the necessary resources to comply with the new regulations. This also strengthens pharmacovigilance in Brazil and other participating countries.

**WHO? **

Therefore, the direct impact is on pharmaceutical companies, healthcare professionals, and patients.

**CONCLUSION: **

The new WHO regulation, implemented by ANVISA, requires pharmaceutical companies to report adverse drug events using the WHODrug dictionary and the E2B (R3) format. This measure has a significant impact, improving drug safety globally and facilitating the aggregation of adverse event information. Companies must adapt within one year, which requires significant efforts in training and system updates. The collaboration between ANVISA and the Uppsala Monitoring Center ensures the technical support necessary to comply with the regulation, indirectly benefiting patients by improving the identification of safety signals in medications.