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Joint Clinical Assessment for Rare Disease Therapies: Preparing for 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 and the Falsified Medicines Directive: Keeping the Supply Chain Safe
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[…]
The Pharmacovigilance System Master File: The First Document an Inspector Asks For
The pharmacovigilance system master file (PSMF) is the single document that describes how a marketing authorisation holder runs its safety system — and it is[…]
The EU Pharma Package: A New Baseline for Exclusivity and Access
After more than two years of negotiation, the European Union has settled the text of its new pharmaceutical legislation — the most significant overhaul of[…]
EU MDR: Transition Deadlines and the EUDAMED Shift
The medical device transition has moved from a cliff edge to a staged runway — but the conditions attached to those extensions have already passed,[…]