FDA INTERACT Meetings: Early Strategic Alignment for Innovative Therapies
At Global Regulatory Partners (GRP), we understand that early regulatory strategy plays a critical role in the success of innovative drug development programs. For companies developing novel therapies—especially those with limited regulatory precedent—the FDA’s INTERACT meeting represents a valuable opportunity to engage with the Agency at a formative stage.
INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER- and CDER-Regulated Products) is designed to support early, focused dialogue between sponsors and FDA reviewers. When strategically utilized, it helps identify potential risks, refine development strategies, and establish a solid regulatory foundation before significant investments are made.
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.
Strengthening Innovation and Compliance Across Pharma, Medical China Regulatory and Cosmetics
China’s National Medical Products Administration (NMPA) has introduced major regulatory updates across pharmaceuticals, medical devices, and cosmetics, emphasizing innovation, lifecycle supervision, and strengthened technical standards. These changes reflect China’s push toward a more predictable, science‑driven regulatory environment that supports development while reinforcing compliance.
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.
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.
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.