Overview
Starting March,2026, ANVISA establishes a new milestone for pharmacovigilance in Brazil the mandatory use of the international dictionaries MedDRA and WHO Drug for all notifications within the VigiMed system. This change aims to integrate Brazilian data into the global health ecosystem, allowing for faster and more accurate risk analysis.
Introduction
The language of drug safety is becoming universal. For an adverse event detected in the heart of Brazil to be understood and analyzed by global health bodies in Switzerland or Japan, standardized coding is essential.
With the mandatory implementation of MedDRA and WHO Drug dictionaries in the VigiMed system, Brazil definitively aligns itself with the best practices of the International Council for Harmonization (ICH). For Marketing Authorization Holders (MAHs), this update represents a significant leap in the technical quality of notifications and a rigorous requirement for the adaptation of internal processes.
What are the MedDRA and WHO Drug Dictionaries
To understand the new requirement, it is necessary to recognize the role of each tool:
MedDRA (Medical Dictionary for Regulatory Activities): An international medical dictionary of highly specific terminology used to classify adverse reactions, symptoms, diagnoses, and medical history.
WHODrug (WHO Drug Global): Maintained by the Uppsala Monitoring Centre (WHO), it is the most comprehensive drug dictionary in the world, used to uniquely identify and code medicinal products and their active ingredients.
Why is Standardization Mandatory in 2026
Until now, many notifications in VigiMed suffered from generic terms or free-text descriptions, which hindered data mining and the identification of “signals” (alerts of new risks).
International Convergence: As an ICH member, Brazil is committed to speaking the “same language” as agencies such as the FDA (USA) and EMA (Europe).
Agility in Signal Detection: Precise coding allows algorithms to identify patterns of adverse events in real-time across large databases.
Impacts for Companies and Professionals
Companies must review their pharmacovigilance Standard Operating Procedures (SOPs) immediately:
- Team Training: Regulatory Affairs and Pharmacovigilance professionals must master the MedDRA hierarchy (from Lowest Level Terms to System Organ Classes).
- IT Systems: Proprietary adverse event management software must be integrated and updated to export files compatible with the E2B(R3) format, which utilizes these dictionaries.
- Data Quality: Notifications submitted without the correct coding starting March 21 may be rejected by the VigiMed system.
Conclusion
The mandatory use of MedDRA and WHO Drug in VigiMed is not just a technical detail, but an ethical evolution. By adopting these standards, the Brazilian pharmaceutical industry contributes to a more robust global database, saving lives through much faster risk identification.
At GRP Brazil, we are ready to assist your company in the transition to the international pharmacovigilance standard, ensuring that your notifications strictly comply with the new ANVISA requirements.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa.
- National Health Surveillance Agency (ANVISA). Guide for Transmission of Adverse Event Reports via VigiMed for Marketing Authorization Holders. Brasília, DF, 2026.
- ICH (International Council for Harmonization). MedDRA Hierarchy and Scope. Available at: meddra.org.
- UPPSALA MONITORING CENTRE. WHODrug Global: The gold standard for drug coding. Available at: who-umc.org.
- ANVISA. RDC No. 406/2020. Provides for Good Pharmacovigilance Practices for Marketing Authorization Holders of Medicinal Products for Human Use.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.