Regulatory Rapporteur November 2026 – Contents
The Americas: Navigating regulatory convergence and divergence
Latin America: From low-cost venue to strategic platform in veterinary clinical research
A lifecycle oversight of veterinary medicines regulation in Latin America
Colombia’s regulatory landscape: Opportunities and barriers
Navigating the fragmented US approach to AI governance: What FDA guidance, State legislation, and divergence from the EU AI Act mean for regulatory teams
The FDA Quality Management System Regulation and the limits of harmonisation: Building a global QMS around a common core
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
Mapping early and often FDA interaction in rare disease programmes: Building the path from discovery to registration
IDMP after the API: From one-time submission to living data governance
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UK confirms indefinite recognition of CE-marked medical devices
The UK government has confirmed that Great Britain will recognise CE-marked medical devices and in vitro diagnostic devices indefinitely, removing the prospect of a mandatory additional approval route for products already authorised for the EU market.
FDA introduces new pilot programme to accelerate early-stage clinical research
The US Food and Drug Administration (FDA) has outlined a series of actions to accelerate and modernise clinical research from the Investigational New Drug phase through to late-stage pivotal studies.
EMA launches new pre-submission interactions model pilot
Beginning in September 2026, the European Medicines Agency (EMA) has invited marketing authorisation applicants to participate in an 18-month pre-submission interactions (PSI) model pilot.
More news
FDA launches final guidance on therapeutic equivalence evaluations
The US Food and Drug Administration (FDA) has issued its final guidance on making therapeutic equivalence evaluations and assigning therapeutic equivalence (TE) codes.
FDA consults on the regulation of GenAI-enabled medical devices
The US Food and Drug Administration (FDA) has released a discussion paper to gather feedback on topics relevant to the regulation of generative artificial intelligence (GenAI)-enabled medical devices.
FDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
New diabetes treatment and a Vetmedin referral: Inside the CVMP July 2026 meeting
The July meeting of the Committee for Veterinary Medicinal Products (CVMP) covered product opinions, a Union referral, scientific advice outcomes, and several guideline updates spanning fixed combinations, novel RNA-based therapies and pharmacovigilance.
RegRapPod − InConversation with TMC Pharma
InConversation talks about conditional marketing authorisation − and how the work starts after approval – with Catherine Moncad
RegRapPod − InConversation with Aman Khera
InConversation talks about opportunities and disruptors within the regulatory affairs industry with Aman Khera
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