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.
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.
The SAKIGAKE Designation Expansion: Fast-Tracking Breakthrough Innovation in Japan
This post details the strategic expansion of the SAKIGAKE system in 2026, a regulatory accelerator that redefines the market entry timeline for cutting-edge therapies and orphan drugs in Japan.
COFEPRIS Introduces Abbreviated Regulatory Pathway (“Reliance”) to Accelerate Health Product Approvals in Mexico
On 2025, the Mexican Federal Commission for Protection against Sanitary Risks (COFEPRIS) published a new regulatory framework in the Diario Oficial de la Federación (DOF) establishing an abbreviated regulatory pathway for sanitary licenses of health products. This mechanism is grounded in the concept of regulatory reliance, whereby COFEPRIS recognizes the evaluation outcomes of trusted foreign regulatory authorities (Reference Regulatory Authorities – RRAs) as the basis for its own approval decisions.
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.
Leadership Transition at COFEPRIS: Regulatory Consistency Risks and the Need for Stability
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is Mexico’s national regulatory authority responsible for protecting public health by overseeing medicines, medical devices, food products, tobacco, and other health-related inputs. COFEPRIS plays a central role in ensuring product safety, authorizing market access, and establishing technical regulatory requirements across the country.
Strategic Alliance in Mexico: COFEPRIS and CCINSHAE Join Forces to Strengthen Patient Safety
This blog details the recent agreement signed between the Federal Commission for Protection against Sanitary Risks (COFEPRIS) and the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (CCINSHAE). The primary objective is to optimize the detection of adverse reactions and medical device incidents within the most complex health institutions in the country.
Mexico Updates NOM-177: What’s Changing and How It Impacts the Pharmaceutical Industry
On December 16,2025, COFEPRIS published the Draft Mexican Official Standard PROY-NOM-177-SSA1-2025, a major update to the regulatory framework governing bioequivalence, comparative bioavailability, BCS-based biowaivers, and comparative dissolution studies. The draft, currently under public consultation, will replace NOM-177-SSA1-2013 and further align Mexico with FDA and EMA standards.
FDA Reissues Cybersecurity Guidance: Strategic Alignment with QMSR and ISO 13485
The U.S. Food and Drug Administration’s (FDA) reissued final guidance regarding quality system management considerations for medical device cybersecurity. The update marks the official transition from the old Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), directly integrating ISO 13485:2016 standards.
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.