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.
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.
Tighter Route: FDA Will Require Randomized Controlled Trials (RCTs) for CAR T-Cell Therapy Approval
The US Food and Drug Administration’s (FDA) Center for Biologic Research and Evaluation (CBER) has announced a significant shift in its regulatory approach for the approval of Chimeric Antigen Receptor (CAR) T-Cell therapies. Top agency officials indicate that, generally, the use of Randomized Controlled Trials (RCTs) will now be required to support new approvals in cancer treatment. This decision marks a transition from single-group studies (based only on response rate) to comparative trials with survival or time-to-event endpoints. The new stance aims to ensure that the benefits of these innovative therapies are measured with the highest standard of scientific evidence.
Clarity and Truth in Advertising: FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars
The US Food and Drug Administration (FDA) has finalized important guidance on the promotional labeling and advertising of reference listed drugs (RLDs), biosimilar products, and, crucially, interchangeable biosimilar products. The primary goal of this document is to ensure that all promotional communications about these products are accurate, truthful, and non-misleading. The publication fulfills a legal requirement (Biosimilar User Fee Amendments of 2022 – BsUFA III) and aims to address industry questions, establishing clear standards for presenting scientific data and information about interchangeability, a key concept for the adoption and success of the biosimilars market.