The Italian Medicines Agency has published definitive rules for the CSE, its unified appraisal body, to streamline clinical and economic drug evaluations.
The national regulator has proposed a comprehensive roadmap to shift pharmaceutical governance toward genomic-driven prescribing to mitigate the clinical and financial risks of an ageing population.
The National Institute for Health and Disability Insurance INAMI/RIZIV has launched a mandatory electronic portal for all early and rapid medicine access applications.
The Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence have replaced their joint advice programme with a formalised integrated service to align regulatory and health technology assessment requirements.
The Spanish Ministry of Health has reported an acceleration in the incorporation of innovative medicines into the national healthcare system following a period of improvements to the approval process.
The Dental and Pharmaceutical Benefits Agency, TLV, has unveiled a strategic shift in pricing logic to accommodate high-cost orphan drugs while enforcing discounts on high-volume products.
The Swiss Federal Council has opened a consultation on measures to curb healthcare costs by introducing volume rebates for high-turnover medicines and formalising price models for innovative therapies.
French regulators have expanded the range of biological medicines eligible for pharmacist-led substitution to include ophthalmic treatments and other high-value therapies.
The Slovak Value for Money Unit has called for a fundamental overhaul of the reimbursement listing process to address repeated budget overruns and tighten cost-effectiveness standards.
The Spanish government has introduced a new regulatory framework to integrate medical device pricing into the national pharmaceutical reimbursement system to stabilise supply and increase oversight.
The EU Member State Coordination Group on Health Technology Assessment (HTACG) has shifted its focus from institutional set-up to operational execution by prioritising long-term pipeline intelligence and assessment continuity.
The Department of Health and Social Care has proposed twelve amendments to pharmaceutical information regulations to improve reimbursement accuracy and enhance the national response to medicine shortages.
The Finnish Pharmaceuticals Pricing Board Hila will hold additional consultation events in May to manage high industry demand for pipeline discussions.
The Department of Health and Social Care has proposed reducing the 2026 statutory scheme payment rate to 16.5 per cent and replacing full public consultations with targeted workshops for trade associations and patient groups.
The EU medicines pricing collaboration EURIPID has updated the core guidance for external reference pricing to help national authorities maintain pharmaceutical affordability without delaying patient access.
The Cyprus Presidency of the EU will prioritise the finalisation of the Critical Medicines Act and the revision of the EU pharmaceutical legislation to address supply vulnerabilities and harmonise medicines access across the bloc.
Ministers have now set out in detail how changes to health technology assessment methods will underpin the UK–US pharmaceuticals deal, confirming that the cost of more generous appraisals will fall on the Department of Health and Social Care budget.
Italy’s Medicines Agency AIFA has released its monitoring report on national and regional pharmaceutical expenditure for January–September 2025, confirming persistent overshoot on hospital and other direct purchases despite only modest growth in community spend.
