The National Institute for Health and Disability Insurance INAMI has confirmed that Belgian health spending remained under the global ceiling in 2025 despite persistent overruns in the pharmaceutical sector.
The Italian Medicines Agency AIFA has formalised a simplified and a fast-track accelerated negotiation route to shorten the timeline for pricing and reimbursement decisions.
The Danish Medicines Agency DKMA has launched a formal consultation to reassess the general reimbursement status of a broad range of oncology treatments.
The National Agency for the Safety of Medicines and Health Products ANSM has met with industry representatives to discuss the regulatory framework for cell and gene therapies.
The National Agency for the Safety of Medicines and Health Products ANSM has digitised the legal notification process for generic groups to remove administrative delays and enable immediate price reductions.
The Swedish Dental and Pharmaceutical Benefits Agency, TLV, has opened a consultation on new regulations for applications for subsidy and pricing of medicines.
Turkey’s Social Security Institution has issued a formal framework for alternative reimbursement applications covering medicines imported from abroad for individual treatment.
The Italian Medicines Agency has published definitive rules for the CSE, its unified appraisal body, to streamline clinical and economic drug evaluations.
The official publication of the new Italian Medicines Agency AIFA regulation confirms the immediate activation of unified clinical and economic assessments carried out by the unitary CSE committee
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.
Ireland has converted January’s agreements in principle into a four-year pricing and supply framework that combines faster reimbursement targets with new measures on off-patent pricing and medicines supply.
The UK government will give ministers a limited power to set NICE’s cost-effectiveness threshold, after a consultation drew strong warnings over political interference and the agency’s independence
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.
