Regulatory Revolution in Japan: The New Pathway for “Specific Use Drugs” in 2026
In 2026, Japan is implementing a structural change in its drug designation process. The new workflow allows companies to apply for the “Drug for Specific Use” classification directly to the PMDA (Pharmaceuticals and Medical Devices Agency), eliminating previous ministerial bureaucratic hurdles and accelerating the arrival of treatments for rare and critical diseases in the Japanese market.
PMDA Modernizes Drug Approvals: The Strategic Rise of Real-World Data (RWD) in Japan
The PMDA’s recent transition to a more agile, data-driven approval model. The focus is on how the integration of ‘real-world’ evidence is redefining access to the Japanese market for global pharmaceutical companies.
Navigating Japan’s New SaMD Regulations: The Dual Frontier of AI and Cybersecurity
This Blog analyses critical PMDA updates for 2026, focusing on artificial intelligence governance and cyber protection for medical software, which are essential for ensuring operational continuity in the Japanese 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.
RDC No. 406/2020: Brazil’s Regulatory Framework for Good Pharmacovigilance Practices
Issued by the Agência Nacional de Vigilância Sanitária (Anvisa), RDC No. 406/2020 establishes the requirements for Good Pharmacovigilance Practices (GVP) applicable to Marketing Authorization Holders (MAHs) of human medicines in Brazil.
The regulation defines responsibilities, organizational structures, systems, timelines, and technical standards to ensure continuous post-marketing safety monitoring of medicinal products, aligning Brazil with internationally recognized pharmacovigilance practices.
Greater Rigor and Safety: ANVISA’s New Guidelines for Impurities and Degradation Products in Medicines
The National Health Regulatory Agency (ANVISA) has published a new set of guidelines regarding the classification, identification, and control of impurities and degradation products in medicines. This update is crucial for the pharmaceutical industry as it establishes clearer and more rigorous criteria for demonstrating product safety and quality. The focus of the new guidelines is to harmonize national practices with international guidelines and ensure that acceptable limits for these substances are consistently monitored throughout the drug’s lifecycle, from production to expiration date.
Navigating the Frontier: The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
The incorporation of Artificial Intelligence and Machine Learning (AI/ML) into medical devices has the potential to revolutionize diagnosis, treatment, and health management. However, the adaptive and constantly evolving nature of these algorithms challenges traditional regulatory frameworks. This article provides an overview of the complex and dynamic global regulatory landscape—with a focus on leading agencies like the FDA (USA) and the European Union (EU)—highlighting the main challenges and the innovative approaches being developed to ensure the safety and effectiveness of these “learning” devices.
Webinar Presents Preliminary Draft of the ICH Q3E Guideline on Impurities in Drug Products
The ICH Q3E Guideline (Impurities: Assessment and Control of Drug Substance and Drug Products) is a crucial directive aimed at harmonizing regulatory approaches for impurity control. This blog post details the main points of the preliminary draft presented in a recent webinar, discussing its impact and the need for preparation by companies, especially within the Brazilian regulatory context.
Building Transparency: FDA Experts Offer Essential Tips for Assembling SBOMs in Medical Devices
The recent discussion among experts at the Medtech conference, highlighted by the FDA, underscores the critical importance of the Software Bill of Materials (SBOM) in medical device cybersecurity. Although SBOM generation tools are still in their early stages, the consensus is clear: manufacturers must start working immediately on assembling these documents. The SBOM is now an essential regulatory requirement for “cyber devices” and crucial for managing risks and ensuring patient safety. Experts emphasize the need for simplification, the inclusion of key partners in the process, and attention to the details of the human-readable format, which complements the machine-readable format required by the FDA.