Κοινή Κλινική Αξιολόγηση για Γονιδιακές Θεραπείες: Στο Πεδίο από την πρώτη Μέρα
Unlike most medicines, gene therapies have been subject to the EU Joint Clinical Assessment (JCA) since it began on 12 January 2025. As advanced therapy[…]
Κοινή Κλινική Αξιολόγηση για την Σπάνια Ασθένεια Θεραπείες: Προετοιμασία για το 2028
The EU Joint Clinical Assessment (JCA) will extend to orphan medicines from January 2028, drawing rare disease therapies into a single, EU-wide clinical assessment. For[…]
Serialisation και την Οδηγία για τα Ψευδεπίγραφα Φάρμακα: Κρατώντας την Αλυσίδα Εφοδιασμού Ασφαλής
Since February 2019, almost every prescription medicine pack in the EU has carried two safety features — a unique 2D barcode and an anti-tampering device[…]
The Qualified Person and Batch Release: The Last Line of Defence
No medicinal product can be placed on the EU market until a Qualified Person (QP) has certified the batch. It is one of the most[…]
Paediatric Investigation Plans: Planning for Children from the Start
For most new medicines in the EU, studying the product in children is not optional. Under the Paediatric Regulation, a paediatric investigation plan (PIP) must[…]
Advanced Therapy Medicinal Products: Navigating the EU Regulatory Pathway
Advanced therapy medicinal products (ATMPs) — gene therapies, somatic-cell therapies and tissue-engineered products — are among the most complex products to bring to the European[…]
Real-World Evidence in EU Medicines Regulation: From Nice-to-Have to Core
Real-world evidence (RWE) has moved from the margins of EU medicines regulation to its core. Through initiatives such as DARWIN EU, the European Medicines Agency[…]
External Reference Pricing in Greece: How Prices Are Set and Reviewed
External reference pricing (ERP) sits at the heart of how medicine prices are set in Greece. For any company launching a product, understanding how the[…]