Regulatory Rapporteur October 2026 – Contents
Clinical trial design and real-world evidence: What happens to the evidence next?
Clinical trial diversity and regulatory decision-making: Implications for dosing, safety and global alignment
The compounding pharmaceutical data gap: The impact of structural under-representation on AI-augmented pharmacovigilance systems
The evolving regulatory framework for clinical data management in the era of decentralised trials
COMBINE EU pilots: Roche’s experience as first pilot participants
Lean writing and disclosure-ready principles for clinical trial design and documents
Multistakeholder collaboration to translate the ICH GCP E6(R3) guideline into Finnish: Supporting clinical trial conduct in Finland
ICH Q6(R1): Harmonising specifications for chemical and biological products
Moving towards one global paediatric development plan
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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.
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.
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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.
CHMP July meeting brings first-of-its-kind eye implant and oral psoriasis breakthrough
At its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for marketing authorisation (three generics, one biosimilar, and eight extensions of indication), while issuing negative opinions on three applications.
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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