- Pharmaceuticals
The end of the two-tier system: A comparative review of the FDA’s 2024/2025 shift on biosimilar interchangeability and its impact on global harmonisation
IDMP after the API: From one-time submission to living data governance
Mapping early and often FDA interaction in rare disease programmes: Building the path from discovery to registration
- Veterinary
Latin America: From low-cost venue to strategic platform in veterinary clinical research
A lifecycle oversight of veterinary medicines regulation in Latin America
A career in veterinary regulatory affairs: Roles and competencies across the product lifecycle
November 2025 – Contents: Veterinary medicines sessions
- Medical devices
The FDA Quality Management System Regulation and the limits of harmonisation: Building a global QMS around a common core
China’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access
From regulation to implementation: Medical device serialisation and traceability in India
- Industry news
- Commentary
- Collections
The Americas: Navigating regulatory convergence and divergence
Welcome to the November 2026 issue of Regulatory Rapporteur which focuses on the Americas.
In this issue, we explore the diverse regulatory landscapes of Latin America and North America, where convergence and divergence create both challenges and opportunities. From veterinary medicines in Latin America to US developments in AI governance, medical devices, biosimilars and rare diseases, discover how regulatory professionals are navigating the region’s evolving frameworks. Plus, explore EU IDMP implementation and the growing importance of data quality and early regulatory strategy.
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