5 March 2026
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 the past month.
EMA
CHMP sets priorities in 2026 workplan
2 February 2026
The Committee for Medicinal Products for Human Use (CHMP) has outlined its 2026 workplan, covering pre-authorisation activities, initial evaluations, specialised areas, and cross-cutting initiatives. The year will focus strongly on preparing the EU regulatory network for implementation of the new pharmaceutical legislation, with the CHMP contributing expertise to ensure regulatory readiness and a smooth transition to the updated framework. Read more
The COMP workplan and CAT workplan for 2026 have also been shared.
EMA
Concept paper proposes revision of GMP Annex 15
9 February 2026
A new concept paper outlines plans to revise Annex 15 of the EU Good Manufacturing Practice guidelines on Qualification and Validation. The proposal would extend the annex’s scope to active substance manufacturers and update selected sections to better align with EudraLex Volume 4, Part II and related guidance, including on GDP, strengthening consistency across GMP requirements. Read more
EMA
ICH M15 sets harmonised framework for model-informed drug development
11 February 2026
The ICH M15 Guideline establishes general principles for planning, evaluating, and documenting evidence derived from model-informed drug development (MIDD). By introducing a harmonised assessment framework and aligned terminology, the guidance aims to support consistent regulatory evaluation of modelling approaches used in medicines development. Read more
EMA
EMA reviews outcomes of stepwise PIP pilot
12 February 2026
A review of the stepwise paediatric investigation plan (sPIP) pilot highlights its role in supporting rare or complex paediatric development programmes where key data are not available at initial submission. The pilot enables progressive agreement of critical study elements through predefined milestones, offering greater flexibility while maintaining regulatory oversight; the review now considers future perspectives for this approach. Read more
EC
EU report calls for high-value cancer care across Member States
3 February 2026
A new EU-funded report highlights disparities, challenges, and examples of good practice in cancer care, urging stronger focus on delivering high-value services for all patients. Produced by the OECD for the European Cancer Inequalities Registry under Europe’s Beating Cancer Plan, the findings aim to inform policy action and reduce inequalities in cancer outcomes across the EU. Read more
EC
EU launches dashboard to track cardiovascular health trends
10 February 2026
A new online “State of Cardiovascular Health in the European Union” dashboard has been launched to help policymakers, researchers, and the public monitor cardiovascular health data across the EU. Unveiled at a joint European Commission and OECD webinar, the tool supports the EU’s Safe Hearts Plan by providing accessible insights from the latest cardiovascular health report. Read more
EC
HTA Coordination Group publishes first annual report under new EU framework
16 February 2026
The Member State Coordination Group on Health Technology Assessment (HTACG) has released its 2025 Annual Report, marking the first year of application of the EU Health Technology Assessment Regulation. The report provides an overview of activities and progress, offering stakeholders insight into how the new EU HTA framework is being implemented in practice. Read more
EC
Commission commits €225 million to next-generation influenza vaccines
20 February 2026
The European Commission is investing €225 million to accelerate the development of next-generation influenza vaccines capable of protecting against a broader range of variants and adapting rapidly to pandemic strains. The funding will also support innovative delivery methods, including nasal, oral, and skin patch formats, and help ensure rapid scale-up in emergency situations. Read more
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