Strengthening Innovation and Compliance Across Pharma, Medical China Regulatory and Cosmetics
China continues to advance its life sciences regulatory framework with a strong emphasis on balancing innovation and regulatory oversight. Recent updates issued by the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) introduce new clinical evaluation guidance for pharmaceuticals and enhanced technical standards for cosmetic ingredients. These measures signal a continued shift toward life cycle-based regulation, scientific consistency, and higher quality standards across regulated products.
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.
Mexico Strengthens Health Security: The Transition from the CNFV to the New CENAFyT
Mexico has taken a decisive step in modernizing its healthcare system with the creation of the National Center for Pharmacovigilance and Technovigilance (CENAFyT). Integrated into the General Health Law, this new body expands supervisory powers over both medicines and medical equipment, ensuring greater protection for all citizens.
The New period of Regulation in Mexico: Modernization and Sovereignty (2024–2026)
Between 2024 and 2026, Mexico underwent a profound transformation of its regulatory landscape for medicines and vaccines. Led by COFEPRIS, this shift focuses on agility through the “regulatory reliance” model, ensuring that medical innovation reaches patients faster without compromising scientific rigor or national sovereignty.
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.
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.