FDA Importation Program Analysis on Colorado’s Prescription Drug Initiative
This FDA Importation Program Analysis confirms that Colorado has secured a two-year authorization to import eligible prescription drugs under its Section 804 Importation Program (SIP), demonstrating that significant cost savings for American consumers are achievable without compromising safety or...
Enhancing Health Technology Assessment Through Real-World Evidence in Portugal
Real-world evidence Portugal has moved from supplementary tool to statutory requirement under Decree-Law 118/2026, which compels national health systems to share interoperable data so that promised outcomes can be verified after medicines and devices reach patients. The legislation converts one-t...
Integrating the Portuguese HTA Regulation into National Health Systems
The Portuguese HTA Regulation has delivered the most significant overhaul of the National System for Health Technology Assessment (SiNATS) since its creation in 2015. Published through Decreto-Lei n.º 118/2026, ...
Pioneering AI PICO Scoping Tool Enhances EU Joint Clinical Assessments
A recently published AI PICO Scoping Tool delivers a practical solution for the demanding requirements of EU Joint Clinical Assessments by automatically extracting and consolidating Population, Intervention, Comparator, and Outcome (PICO) elements from disparate health technology assessment repor...
Regulatory Insights on Dapagliflozin Pricing Framework
Portugal’s Dapagliflozin Pricing Framework establishes a single reference price for all reimbursed 10 mg dapagliflozin tablets by creating homogeneous group GH1326. According to INFARMED’s latest notificat...
Multistakeholder Approaches to Optimize Oncology Market Access Strategy
Effective oncology market access strategy has become markedly more complex as geopolitical pressures reshape how innovative cancer therapies reach patients, as made clear in Iroda Jurabekova’s pharma summit presentation. Determining whethe...
