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What You Need to Know About ANVISA RDC No. 967/25 and Its Impact on Pharmacovigilance
What is ANVISA RDC No. 967/25 and when does it take effect?
ANVISA RDC No. 967/25 is a regulatory update published on March 20, 2025, and it will come into effect on March 18, 2026. It amends the previous Resolution RDC No. 406/2020 and introduces new requirements for adverse event reporting in Brazil.
Who is affected by this regulation?
The regulation applies to Holders of Drug Registration (DRM), who are now required to use VigiMed to submit adverse drug reaction (ADR) reports to the National Health Surveillance System (SNVS)/ANVISA.
What are the technical requirements for submitting ADRs?
Submissions must comply with the E2B(R3) standard defined by the International Council for Harmonisation (ICH). Reports can be submitted either manually or by importing compatible XML files.
What coding standards must be used for medical terms and products?
The regulation mandates the use of:
- MedDRA (Medical Dictionary for Regulatory Activities) for coding adverse events and reactions.
- WHODrug Global for coding medicines, including vaccines.
Where can companies find guidance on these requirements?
Detailed regional specifications are outlined in the VigiMed Companion Guide and the Instructions for the Creation of ICH E2B XML Files, both of which are available on the ANVISA Portal.
How is EVERSANA supporting compliance with these new requirements?
EVERSANA has integrated all of these regulatory elements into its ADR case processing platform. Its human expert–led GenAI tools help streamline the reporting process and ensure accurate, error-free submissions.
With the March 2026 implementation date approaching, now is the time for MAHs to align their systems and processes with ANVISA’s updated requirements. By leveraging expert-led GenAI tools and a robust ADR case processing platform, EVERSANA ensures seamless compliance and efficient reporting. Staying informed and prepared today means fewer disruptions and greater confidence.
Author
Nitin is an accomplished professional with over 20 years of experience spanning Good Vigilance Practice (GVP), Good Clinical Practice (GCP), bioanalytical science and software validation. He previously held the Senior Manager – GVP QA…