5 December 2025
From the regulatory newsfeeds of the European Medicines Agency’s (EMA), the European Commission (EC) and the Heads of Medicine Agencies (HMA), Arex Advisor has rounded up a selection of highlights from November 2025.
EMA
EMA outlines its role in ensuring medicine safety
6 November 2025
The European Medicines Agency explains how it evaluates medicines for safety, effectiveness, and quality before approval, and how it continues tracking their safety once they reach the EU market. The update highlights the Agency’s central role in safeguarding patients and supporting regulatory decision-making. Read more
EMA
Personalised medicine tailors cancer care to tumour biomarkers
7 November 2025
Personalised medicine in oncology focuses on adapting treatment to the specific molecular and genetic features of an individual patient’s tumour. By using these biomarkers, clinicians can select more targeted and potentially more effective therapies – a key approach underpinning modern precision oncology. Read more
EMA
Updated guidance clarifies non-inferiority and equivalence trial design
13 November 2025
A revised scientific guideline sets out how sponsors should plan, run, analyse and interpret non-inferiority and equivalence comparisons in clinical trials. It consolidates and replaces earlier guidance on selecting non-inferiority margins and on switching between superiority and non-inferiority, offering a clearer framework for study design and regulatory assessment. Read more
Guideline on non-inferiority and equivalence comparisons in clinical trials
EMA
EMA streamlines scientific advice for medicines targeting public health threats
17 November 2025
EMA’s Emergency Task Force has introduced an improved process to support developers of promising medicines and vaccines for public health threats, including antimicrobial resistance. The new approach enables companies to request combined scientific advice from EMA alongside national clinical trial and ethics experts, helping align trial and authorisation requirements early and ultimately speeding up clinical trial approval and access to critical medicines. Read more
EMA
EMA explains new SA-CTA process to harmonise regulatory advice
17 November 2025
EMA has issued guidance on SA-CTA, a form of scientific advice delivered under the Emergency Task Force’s mandate to align input from EU authorities responsible for both medicines authorisation and clinical trial authorisation. The approach aims to harmonise expectations early in development, giving applicants clearer and more consistent regulatory guidance for products addressing public health threats. Read more
EMA
EMA addresses common concerns and false claims about vaccines
21 November 2025
The European Medicines Agency has published information to clarify frequent questions and misconceptions about vaccines, aiming to support public understanding and counter false claims. The resource explains how vaccines are assessed and monitored, helping reinforce confidence in their safety and effectiveness. Read more
EC
Commission releases first monitoring report on European Reference Networks
17 November 2025
The European Commission has issued its first monitoring report on the European Reference Networks, which bring together 24 specialist groups focused on rare, complex, and low-prevalence diseases. The report shows a 160% rise in new patient referrals over six years across 1,606 ERN clinical centres, underscoring the Networks’ growing impact on coordinated rare-disease care across EU Member States and Norway. Read more
EC
Commission publishes interim evaluation of EU4Health Programme
25 November 2025
The European Commission has published an interim review of the €4.6 billion EU4Health Programme, highlighting its role in strengthening health systems and supporting post-COVID recovery across the EU. The assessment notes that the programme has helped Member States improve healthcare resilience, accessibility, and crisis preparedness as part of its 2021–2027 mandate. Read more
HMA
Commission publishes final guidance on revised variations framework
4 November 2025
The European Commission has released its final guidelines detailing variation categories and procedural requirements following the updated Variation Regulation in force since January 2025. The guidance, which will apply from 15 January 2026, provides clarity for marketing authorisation holders preparing for the revised regulatory approach. Read more
HMA
NCAs introduce fast-track route for multinational clinical trial approvals
27 November 2025
National Competent Authorities and Ethics Committees have agreed to pilot a coordinated fast-track process for assessing multinational clinical trials across the EU/EEA. The initiative aims to streamline evaluations and shorten timelines, supporting more efficient trial start-up for developers conducting studies in multiple countries. Read more
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