The Future of Digital Health: ANVISA and the New Era of AI in Software as a Medical Device (SaMD)
This Blog details the revision of RDC No. 657/2022 by ANVISA, driven by the rise of Generative AI. We discuss how new risk classification criteria impact the development of software that diagnoses and suggests treatments, ensuring patient safety without stifling innovation.
Brazil and Mexico: A New Era of Sanitary Integration and Innovation in Latin America
This article explores the recent strengthening of bilateral cooperation between the regulatory agencies of Brazil and Mexico. The central focus is the harmonization of standards to accelerate the registration of medicines and medical devices, while fostering regional biotech innovation hubs.
EMA Guidance on GMP Considerations for Additive Manufacturing of Solid Oral Dosage Forms
The European Medicines Agency (EMA) has issued guidance addressing Good Manufacturing Practice (GMP) considerations for the use of additive manufacturing, also known as 3D printing (3DP), in the production of solid oral dosage forms. This guidance represents a significant step toward integrating innovative manufacturing technologies into the pharmaceutical regulatory framework while ensuring product quality, safety, and efficacy.
LMR 2026 Update: How Normative Instruction No. 428 Impacts Pharmaceutical Competitiveness
On March, 2026, ANVISA published Normative Instruction (IN) No. 428, bringing crucial updates to the Reference Medicines List (LMR). This movement is vital for companies seeking to register generics and similar drugs, ensuring that bioequivalence and bioavailability studies use the correct comparator.
Global Pharmacovigilance: Mandatory Use of MedDRA and WHO Drug in the VigiMed System
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.
Regulatory Modernization in Brazil: ANVISA’s Path Toward Traceability and Agility in 2026
The Brazilian regulatory landscape in 2026 solidifies the transition to a fully digital environment. With the mandatory implementation of Unique Device Identification (UDI) and new rules for electronic prescriptions, ANVISA focuses on patient safety and the de-bureaucratization of processes.
Registration Hosting: Protecting Your Brand in Brazil
Entering the Brazilian market requires more than just a great product; it demands compliance with one of the world’s most rigorous regulatory agencies: ANVISA. This blog post explains how Registration Hosting serves as a strategic solution for foreign companies seeking agility, reduced operational costs, and legal protection for their brands in Brazil.
Mastering RDC 406/2020 – Good Pharmacovigilance Practices in Brazil
This blog post explores the critical guidelines established by RDC 406/2020, which regulates Good Pharmacovigilance Practices (GVP) for Marketing Authorization Holders (MAH) in Brazil. We will break down the responsibilities, the required organizational structure, and how compliance with these ANVISA standards ensures safety within the Brazilian pharmaceutical market.
ANVISA Clarifies the Unification of Petition Subject Codes for GMP Certification (CBPF)
The Brazilian Health Regulatory Agency (ANVISA) recently published an official clarification regarding the unification of petition subject codes used for submissions related to the Certificate of Good Manufacturing Practices (CBPF) for medical devices.
Brazil x United States: A Comparison of Post-Marketing Pharmacovigilance Requirements (RDCs x FDA)
Post-marketing pharmacovigilance is a critical component of medicines regulation in both Brazil and the United States. While both countries share the common goal of protecting public health, their regulatory frameworks differ in reporting timelines, safety reporting systems, and approaches to risk minimization.
This Blog provides a comparative analysis of Brazilian requirements—primarily established under RDC No. 406/2020 and RDC No. 967/2025—and the U.S. pharmacovigilance model overseen by the Food and Drug Administration (FDA), with a focus on reporting timelines, VigiMed x FAERS, and risk management strategies.
Regulatory Priorities of Anvisa for 2026–2027: Efficiency, Agility, and Backlog Reduction in Regulatory Processes
As Brazil enters the 2026–2027 regulatory cycle, Anvisa has placed regulatory efficiency, backlog reduction, and process modernization at the center of its strategic agenda. This article outlines the agency’s main regulatory priorities and analyzes their expected impact on companies operating in the Brazilian life sciences and healthcare sectors.
Brazil’s Pharmacovigilance Framework: From RDC 406/2020 to RDC 967/2025
Brazil has undergone a significant regulatory evolution in pharmacovigilance over the past few years. With the publication of RDC No. 406/2020, the country established a consolidated framework for Good Pharmacovigilance Practices applicable to Marketing Authorization Holders (MAHs). In 2025, this framework was further strengthened by RDC No. 967/2025, reinforcing governance, risk-based oversight, and international harmonization.